Stage II Childhood Hodgkin Lymphoma, Stage III Childhood Hodgkin Lymphoma, Stage IV Childhood Hodgkin Lymphoma
Conditions
Keywords
Pediatric cancer, Hodgkin lymphoma, Targeted therapy, Frontline therapy, Brentuximab vedotin, Quality of Life, OEPA/COPDac
Brief summary
This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer cells and reduce the need for radiation therapy.
Detailed description
PRIMARY OBJECTIVES: * To evaluate the safety of brentuximab vedotin, etoposide, prednisone and doxorubicin hydrochloride (AEPA)/cyclophosphamide, brentuximab vedotin, prednisone and dacarbazine (CAPDac), as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high risk patients with Hodgkin lymphoma (HL). * To compare the event-free survival in high risk HL patients treated with AEPA/CAPDac to the historical control unfavorable risk 2 arm (UR2) of the St. Jude HOD99 study. SECONDARY OBJECTIVES: * To estimate the number of patients with adequate response according to the definitions in the Euro-Net C1 after 2 cycles of AEPA. * To evaluate the safety of Adcetris (brentuximab vedotin) in the AEPA/CAPDac regimen in children with high risk HL. * To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. * To study the association between local failure and original lymph node region and volume of radiation (patterns of treatment failure). * To assess patient-reported symptoms and health-related quality of life in children with high risk HL compared to those treated on the unfavorable treatment arm of the St. Jude HOD99 study. OUTLINE: AEPA REGIMEN: Patients receive brentuximab vedotin on days 1, 8, and 15, etoposide on days 1 to 5, prednisone three times daily (TID) on days 1 to 15, and doxorubicin hydrochloride on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. CAPDac REGIMEN: Patients receive cyclophosphamide on days 1 and 8, brentuximab vedotin days 1 and 8, prednisone TID on days 1 to 15, and dacarbazine on days 1 to 3. Treatment repeats every 21-28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after CAPDac chemotherapy, patients with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy undergo radiation therapy daily, 5 days a week for 3-4 weeks. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.
Interventions
DRUGbrentuximab vedotin
Given intravenously (IV).
DRUGetoposide
Given IV.
DRUGprednisone
Given orally (PO).
DRUGdoxorubicin
Given IV.
DRUGcyclophosphamide
Given IV.
DRUGDacarbazine(R)
Given IV.
DRUGfilgrastim
Given subcutaneously (SQ) as clinically indicated.
OTHERquality of life assessment
Quality of life assessment will be done at initial clinical visit, and during chemotherapy, completion of therapy, then at 1 year, 2 years and 5 years. It should take no more than 15-20 minutes to complete. Participation is voluntary by participating institution and by participant.
RADIATIONradiation therapy
At the end of chemotherapy and recovery of blood counts, radiotherapy will be given to any involved nodes (if any) that are not in complete remission.
Sponsors
St. Jude Children's Research Hospital
Seagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL). (Participants receiving limited emergent radiation therapy (RT) or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment). * Age ≤ 18 years at the time of diagnosis (i.e., participants are eligible until their 19th birthday). * Ann Arbor stage IIB, IIIB, IVA, or IVB. * Adequate renal function based on GFR ≥ 70 ml/min/1.73m\^2 or serum creatinine adjusted for age and gender. * Adequate hepatic function (total bilirubin \< 1.5 x ULN for age, and SGOT/SGPT \< 2.5 x ULN for age). * Female participant who is post-menarchal must have a negative urine or serum pregnancy test. * Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.
Exclusion criteria
* CD30 negative HL. * Has received prior therapy for Hodgkin lymphoma, except as noted above. * Inadequate organ function as described above. * Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control | After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment) | To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients. |
| Complete Response Rate Estimate for All Evaluable Participants | After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant) | To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL). |
| Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2). | From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment) | Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac. | From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment) | The local failure rate within the high-risk HL participants treated with AEPA/CAPDac will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). |
| Descriptive of Hematological Adverse Events | From enrollment to end of therapy (approximately 8 months) | To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. |
| Descriptive of Infectious Adverse Events | From enrollment to end of therapy (approximately 8 months) | To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. |
| Descriptive of Neuropathic Adverse Events | From enrollment to end of therapy (approximately 8 months) | To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. |
| To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4) | Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 3. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life. |
| To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4) | Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 4. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life. |
| Response Rate | after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment) | Response compared to the Euro-Net C1 after 2 cycles of AEPA. |
| Patient Quality of Life (QoL) | At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment). | Patient QOL will be measured at multiple time points to assess the patient's physical emotional, social, and school functioning. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life. |
| Parent Proxy Quality of Life (QoL) | At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment) | Parent's assessment of child's physical, emotional, social and school functioning over multiple time points. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life. |
| Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment) | The correlation of agreement between patient and parent Quality of Life is calculated by using the Pearson's Correlation Coefficient, which considers only the record with both parent and patient data. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatt Ehrhardt, MD
St. Jude Children's Research Hospital
Participant flow
Recruitment details
Participants were enrolled at 5 institutions between August 2013 to July 2018.
Pre-assignment details
All the 77 patients are eligible for the study. Two out of 77 enrolled patients did not complete the study. One patient died during therapy, and 1 patient withdrew from the study. But both patients are evaluable for the primary objective.
Participants by arm
| Arm | Count |
|---|---|
| AEPA/CAPDac Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive:
2 cycles of AEPA chemotherapy:
(A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m\^2 IV days 1-5, (P) Prednisone 60 mg/m\^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m\^2 IV days 1 and 15),
Followed by 4 cycles of CAPDac:
(C) Cyclophosphamide 500 mg/m\^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m\^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m\^2 IV days 1-3.).
Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated.
For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given. | 77 |
| Total | 77 |
Baseline characteristics
| Characteristic | AEPA/CAPDac |
|---|---|
| Age, Continuous | 16 years |
| Histology Classical, NOS | 11 Participants |
| Histology Lymphocyte rich | 4 Participants |
| Histology Mixed cellularity | 3 Participants |
| Histology Nodular sclerosing | 59 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants |
| Race/Ethnicity, Customized More than one race | 4 Participants |
| Race/Ethnicity, Customized Others | 2 Participants |
| Race/Ethnicity, Customized White | 50 Participants |
| Region of Enrollment United States Dana Farber Cancer Institute | 4 Participants |
| Region of Enrollment United States Maine Medical Center | 1 Participants |
| Region of Enrollment United States Massachusetts General Hospital | 2 Participants |
| Region of Enrollment United States Stanford University Medical Center | 9 Participants |
| Region of Enrollment United States St. Jude Children's Research Hospital | 59 Participants |
| Region of Enrollment United States St. Jude Midwest Affiliate | 2 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 38 Participants |
| Stage IIB | 13 Participants |
| Stage IIIB | 19 Participants |
| Stage IVA | 12 Participants |
| Stage IVB | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 77 |
| other Total, other adverse events | 75 / 77 |
| serious Total, serious adverse events | 2 / 77 |
Outcome results
Primary
Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2).
Time frame: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
Population: For HLHR13, all the evaluable participants that treated with AEPA/CAPDac; for HOD99 Unfavorable Risk 2 Arm (UR2), all the evaluable participants that treated with Stanford V + RT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AEPA Chemotherapy | Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2). | 0.974 probability |
Comparison: The comparison of the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2) was done by the two-sample log-rank test.p-value: 0.0008Log Rank
Primary
Complete Response Rate Estimate for All Evaluable Participants
To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL).
Time frame: After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)
Population: All the evaluable participants that completed the first 2 cycles of chemotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AEPA Chemotherapy | Complete Response Rate Estimate for All Evaluable Participants | 35 percentage of participants |
Comparison: Comparison of proportion of patient's complete response rate between HLHR13 and HOD99 (NCT00145600) unfavorable risk arm 2 (UR2).p-value: 0.004Fisher Exact
Primary
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.
Time frame: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Population: The first 32 evaluable participants enrolled was evaluated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AEPA Chemotherapy | Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control | 31.25 percentage of participants |
Comparison: In the historical control (HOD99) 17% of patients had CR at week 8. Sample size for this objective is calculated based on a binomial distribution to test H0: p=17% vs. Ha: p\>17%, where p is the true CR rate after 2 cycles of AEPA. 32 patients are needed to detect 20% increase of CR rate with 80% power and 5% type I error. If it shows efficacy, the response results will be reported, and the study will continue to enroll for a total of 77 patients to assess response and EFS.
Primary
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.
Time frame: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Population: The first 32 evaluable participants enrolled was evaluated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AEPA Chemotherapy | Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control | 31.25 percentage of participants |
Secondary
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points
The correlation of agreement between patient and parent Quality of Life is calculated by using the Pearson's Correlation Coefficient, which considers only the record with both parent and patient data. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Time frame: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)
Population: Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by participant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AEPA Chemotherapy | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Physical Functioning | 0.701 correlation coefficient |
| AEPA Chemotherapy | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Social Functioning | 0.309 correlation coefficient |
| AEPA Chemotherapy | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Emotional Functioning | 0.593 correlation coefficient |
| AEPA Chemotherapy | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | School Functioning | 0.444 correlation coefficient |
| Cycle 1 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | School Functioning | 0.577 correlation coefficient |
| Cycle 1 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Social Functioning | 0.566 correlation coefficient |
| Cycle 1 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Physical Functioning | 0.503 correlation coefficient |
| Cycle 1 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Emotional Functioning | 0.664 correlation coefficient |
| Cycle 2 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Physical Functioning | 0.536 correlation coefficient |
| Cycle 2 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | School Functioning | 0.501 correlation coefficient |
| Cycle 2 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Social Functioning | 0.534 correlation coefficient |
| Cycle 2 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Emotional Functioning | 0.648 correlation coefficient |
| Cycle 2 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Physical Functioning | 0.575 correlation coefficient |
| Cycle 2 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Social Functioning | 0.242 correlation coefficient |
| Cycle 2 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Emotional Functioning | 0.588 correlation coefficient |
| Cycle 2 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | School Functioning | 0.441 correlation coefficient |
| Cycle 3 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | School Functioning | 0.694 correlation coefficient |
| Cycle 3 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Emotional Functioning | 0.344 correlation coefficient |
| Cycle 3 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Social Functioning | 0.086 correlation coefficient |
| Cycle 3 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Physical Functioning | 0.406 correlation coefficient |
| Cycle 3 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | School Functioning | 0.315 correlation coefficient |
| Cycle 3 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Emotional Functioning | 0.671 correlation coefficient |
| Cycle 3 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Social Functioning | 0.327 correlation coefficient |
| Cycle 3 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Physical Functioning | 0.528 correlation coefficient |
| Cycle 4 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | School Functioning | 0.209 correlation coefficient |
| Cycle 4 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Physical Functioning | 0.468 correlation coefficient |
| Cycle 4 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Emotional Functioning | 0.291 correlation coefficient |
| Cycle 4 - Grade 2 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Social Functioning | 0.135 correlation coefficient |
| Cycle 4 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Social Functioning | -0.027 correlation coefficient |
| Cycle 4 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Emotional Functioning | 0.756 correlation coefficient |
| Cycle 4 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | School Functioning | 0.574 correlation coefficient |
| Cycle 4 - Grade 3-4 | Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points | Physical Functioning | 0.294 correlation coefficient |
Secondary
Descriptive of Hematological Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Time frame: From enrollment to end of therapy (approximately 8 months)
Population: Toxicities reported below for the current study (HLHR13) include all reported hematological toxicities from a participant's on-study date through end of therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AEPA Chemotherapy | Descriptive of Hematological Adverse Events | Leukopenia | 15 Participants |
| AEPA Chemotherapy | Descriptive of Hematological Adverse Events | Thrombocytopenia | 3 Participants |
| AEPA Chemotherapy | Descriptive of Hematological Adverse Events | Lymphopenia | 15 Participants |
| AEPA Chemotherapy | Descriptive of Hematological Adverse Events | Anemia | 23 Participants |
| AEPA Chemotherapy | Descriptive of Hematological Adverse Events | Neutropenia | 5 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Hematological Adverse Events | Leukopenia | 49 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 3 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Hematological Adverse Events | Neutropenia | 62 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Hematological Adverse Events | Anemia | 12 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Hematological Adverse Events | Lymphopenia | 36 Participants |
| Cycle 2 - Grade 2 | Descriptive of Hematological Adverse Events | Lymphopenia | 18 Participants |
| Cycle 2 - Grade 2 | Descriptive of Hematological Adverse Events | Neutropenia | 13 Participants |
| Cycle 2 - Grade 2 | Descriptive of Hematological Adverse Events | Anemia | 28 Participants |
| Cycle 2 - Grade 2 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 2 Participants |
| Cycle 2 - Grade 2 | Descriptive of Hematological Adverse Events | Leukopenia | 28 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Hematological Adverse Events | Neutropenia | 51 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Hematological Adverse Events | Leukopenia | 23 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 1 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Hematological Adverse Events | Anemia | 5 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Hematological Adverse Events | Lymphopenia | 15 Participants |
| Cycle 3 - Grade 2 | Descriptive of Hematological Adverse Events | Lymphopenia | 9 Participants |
| Cycle 3 - Grade 2 | Descriptive of Hematological Adverse Events | Leukopenia | 8 Participants |
| Cycle 3 - Grade 2 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 0 Participants |
| Cycle 3 - Grade 2 | Descriptive of Hematological Adverse Events | Anemia | 6 Participants |
| Cycle 3 - Grade 2 | Descriptive of Hematological Adverse Events | Neutropenia | 7 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Hematological Adverse Events | Leukopenia | 4 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 2 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Hematological Adverse Events | Anemia | 1 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Hematological Adverse Events | Lymphopenia | 7 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Hematological Adverse Events | Neutropenia | 10 Participants |
| Cycle 4 - Grade 2 | Descriptive of Hematological Adverse Events | Lymphopenia | 16 Participants |
| Cycle 4 - Grade 2 | Descriptive of Hematological Adverse Events | Leukopenia | 5 Participants |
| Cycle 4 - Grade 2 | Descriptive of Hematological Adverse Events | Neutropenia | 5 Participants |
| Cycle 4 - Grade 2 | Descriptive of Hematological Adverse Events | Anemia | 6 Participants |
| Cycle 4 - Grade 2 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 0 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Hematological Adverse Events | Lymphopenia | 15 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Hematological Adverse Events | Neutropenia | 3 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Hematological Adverse Events | Leukopenia | 5 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Hematological Adverse Events | Anemia | 0 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 1 Participants |
| Cycle 5 - Grade 2 | Descriptive of Hematological Adverse Events | Anemia | 4 Participants |
| Cycle 5 - Grade 2 | Descriptive of Hematological Adverse Events | Lymphopenia | 13 Participants |
| Cycle 5 - Grade 2 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 0 Participants |
| Cycle 5 - Grade 2 | Descriptive of Hematological Adverse Events | Neutropenia | 4 Participants |
| Cycle 5 - Grade 2 | Descriptive of Hematological Adverse Events | Leukopenia | 7 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Hematological Adverse Events | Anemia | 1 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 1 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Hematological Adverse Events | Lymphopenia | 22 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Hematological Adverse Events | Neutropenia | 3 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Hematological Adverse Events | Leukopenia | 2 Participants |
| Cycle 6 - Grade 2 | Descriptive of Hematological Adverse Events | Leukopenia | 14 Participants |
| Cycle 6 - Grade 2 | Descriptive of Hematological Adverse Events | Neutropenia | 8 Participants |
| Cycle 6 - Grade 2 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 1 Participants |
| Cycle 6 - Grade 2 | Descriptive of Hematological Adverse Events | Lymphopenia | 20 Participants |
| Cycle 6 - Grade 2 | Descriptive of Hematological Adverse Events | Anemia | 2 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Hematological Adverse Events | Anemia | 1 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Hematological Adverse Events | Neutropenia | 6 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Hematological Adverse Events | Lymphopenia | 31 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Hematological Adverse Events | Leukopenia | 5 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Hematological Adverse Events | Thrombocytopenia | 2 Participants |
Secondary
Descriptive of Infectious Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Time frame: From enrollment to end of therapy (approximately 8 months)
Population: Toxicities reported below for the current study (HLHR13) include all reported infectious toxicities from a participant's on-study date through end of therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AEPA Chemotherapy | Descriptive of Infectious Adverse Events | Upper respiratory infection | 5 Participants |
| AEPA Chemotherapy | Descriptive of Infectious Adverse Events | Mucositis | 10 Participants |
| AEPA Chemotherapy | Descriptive of Infectious Adverse Events | Genitourinary infection | 1 Participants |
| AEPA Chemotherapy | Descriptive of Infectious Adverse Events | Febrile neutropenia | 0 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Infectious Adverse Events | Mucositis | 2 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 6 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 2 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Infectious Adverse Events | Genitourinary infection | 0 Participants |
| Cycle 2 - Grade 2 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 0 Participants |
| Cycle 2 - Grade 2 | Descriptive of Infectious Adverse Events | Mucositis | 6 Participants |
| Cycle 2 - Grade 2 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 3 Participants |
| Cycle 2 - Grade 2 | Descriptive of Infectious Adverse Events | Genitourinary infection | 1 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 3 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Infectious Adverse Events | Genitourinary infection | 0 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Infectious Adverse Events | Mucositis | 4 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 0 Participants |
| Cycle 3 - Grade 2 | Descriptive of Infectious Adverse Events | Mucositis | 0 Participants |
| Cycle 3 - Grade 2 | Descriptive of Infectious Adverse Events | Genitourinary infection | 2 Participants |
| Cycle 3 - Grade 2 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 0 Participants |
| Cycle 3 - Grade 2 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 0 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 0 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Infectious Adverse Events | Mucositis | 0 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Infectious Adverse Events | Genitourinary infection | 0 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 0 Participants |
| Cycle 4 - Grade 2 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 0 Participants |
| Cycle 4 - Grade 2 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 0 Participants |
| Cycle 4 - Grade 2 | Descriptive of Infectious Adverse Events | Mucositis | 1 Participants |
| Cycle 4 - Grade 2 | Descriptive of Infectious Adverse Events | Genitourinary infection | 1 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Infectious Adverse Events | Mucositis | 0 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 2 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Infectious Adverse Events | Genitourinary infection | 0 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 2 Participants |
| Cycle 5 - Grade 2 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 0 Participants |
| Cycle 5 - Grade 2 | Descriptive of Infectious Adverse Events | Genitourinary infection | 2 Participants |
| Cycle 5 - Grade 2 | Descriptive of Infectious Adverse Events | Mucositis | 1 Participants |
| Cycle 5 - Grade 2 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 0 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 1 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 0 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Infectious Adverse Events | Mucositis | 0 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Infectious Adverse Events | Genitourinary infection | 0 Participants |
| Cycle 6 - Grade 2 | Descriptive of Infectious Adverse Events | Mucositis | 1 Participants |
| Cycle 6 - Grade 2 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 0 Participants |
| Cycle 6 - Grade 2 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 0 Participants |
| Cycle 6 - Grade 2 | Descriptive of Infectious Adverse Events | Genitourinary infection | 0 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Infectious Adverse Events | Febrile neutropenia | 0 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Infectious Adverse Events | Upper respiratory infection | 0 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Infectious Adverse Events | Mucositis | 0 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Infectious Adverse Events | Genitourinary infection | 0 Participants |
Secondary
Descriptive of Neuropathic Adverse Events
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Time frame: From enrollment to end of therapy (approximately 8 months)
Population: Toxicities reported below for the current study (HLHR13) include all reported neuropathic toxicities from a participant's on-study date through end of therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AEPA Chemotherapy | Descriptive of Neuropathic Adverse Events | Neuralgia | 1 Participants |
| AEPA Chemotherapy | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| AEPA Chemotherapy | Descriptive of Neuropathic Adverse Events | Pain NOS | 1 Participants |
| AEPA Chemotherapy | Descriptive of Neuropathic Adverse Events | Pain in extremity | 3 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 1 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain NOS | 0 Participants |
| Cycle 1 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Neuralgia | 0 Participants |
| Cycle 2 - Grade 2 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 4 Participants |
| Cycle 2 - Grade 2 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 1 Participants |
| Cycle 2 - Grade 2 | Descriptive of Neuropathic Adverse Events | Pain NOS | 1 Participants |
| Cycle 2 - Grade 2 | Descriptive of Neuropathic Adverse Events | Neuralgia | 0 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain NOS | 0 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 0 Participants |
| Cycle 2 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Neuralgia | 0 Participants |
| Cycle 3 - Grade 2 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 2 Participants |
| Cycle 3 - Grade 2 | Descriptive of Neuropathic Adverse Events | Neuralgia | 0 Participants |
| Cycle 3 - Grade 2 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 1 Participants |
| Cycle 3 - Grade 2 | Descriptive of Neuropathic Adverse Events | Pain NOS | 0 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Neuralgia | 0 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 0 Participants |
| Cycle 3 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain NOS | 0 Participants |
| Cycle 4 - Grade 2 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 3 Participants |
| Cycle 4 - Grade 2 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 1 Participants |
| Cycle 4 - Grade 2 | Descriptive of Neuropathic Adverse Events | Pain NOS | 0 Participants |
| Cycle 4 - Grade 2 | Descriptive of Neuropathic Adverse Events | Neuralgia | 0 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain NOS | 0 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 0 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| Cycle 4 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Neuralgia | 0 Participants |
| Cycle 5 - Grade 2 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 2 Participants |
| Cycle 5 - Grade 2 | Descriptive of Neuropathic Adverse Events | Pain NOS | 0 Participants |
| Cycle 5 - Grade 2 | Descriptive of Neuropathic Adverse Events | Neuralgia | 1 Participants |
| Cycle 5 - Grade 2 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 1 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Neuralgia | 0 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 0 Participants |
| Cycle 5 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain NOS | 0 Participants |
| Cycle 6 - Grade 2 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 0 Participants |
| Cycle 6 - Grade 2 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 1 Participants |
| Cycle 6 - Grade 2 | Descriptive of Neuropathic Adverse Events | Pain NOS | 1 Participants |
| Cycle 6 - Grade 2 | Descriptive of Neuropathic Adverse Events | Neuralgia | 0 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Neuralgia | 0 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Peripheral sensory neuropathy | 0 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain in extremity | 0 Participants |
| Cycle 6 - Grade 3-4 | Descriptive of Neuropathic Adverse Events | Pain NOS | 1 Participants |
Secondary
Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac.
The local failure rate within the high-risk HL participants treated with AEPA/CAPDac will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
Time frame: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
Population: All the evaluable participants treated with AEPA/CAPDac.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AEPA Chemotherapy | Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac. | 0.013 Probability |
Secondary
Parent Proxy Quality of Life (QoL)
Parent's assessment of child's physical, emotional, social and school functioning over multiple time points. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Time frame: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)
Population: Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by parent.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AEPA Chemotherapy | Parent Proxy Quality of Life (QoL) | Emotional Functioning | 61.9 score on a scale | Standard Deviation 23.1 |
| AEPA Chemotherapy | Parent Proxy Quality of Life (QoL) | School Functioning | 63.2 score on a scale | Standard Deviation 25.4 |
| AEPA Chemotherapy | Parent Proxy Quality of Life (QoL) | Physical Functioning | 61.8 score on a scale | Standard Deviation 26.9 |
| AEPA Chemotherapy | Parent Proxy Quality of Life (QoL) | Social Functioning | 80.3 score on a scale | Standard Deviation 18.8 |
| Cycle 1 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Physical Functioning | 65.3 score on a scale | Standard Deviation 20.8 |
| Cycle 1 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Emotional Functioning | 69.3 score on a scale | Standard Deviation 25.2 |
| Cycle 1 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Social Functioning | 79.2 score on a scale | Standard Deviation 21.6 |
| Cycle 1 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | School Functioning | 68.5 score on a scale | Standard Deviation 25.6 |
| Cycle 2 - Grade 2 | Parent Proxy Quality of Life (QoL) | Emotional Functioning | 72 score on a scale | Standard Deviation 22.5 |
| Cycle 2 - Grade 2 | Parent Proxy Quality of Life (QoL) | School Functioning | 67.1 score on a scale | Standard Deviation 25.3 |
| Cycle 2 - Grade 2 | Parent Proxy Quality of Life (QoL) | Physical Functioning | 66.8 score on a scale | Standard Deviation 22.3 |
| Cycle 2 - Grade 2 | Parent Proxy Quality of Life (QoL) | Social Functioning | 79.6 score on a scale | Standard Deviation 18.4 |
| Cycle 2 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Social Functioning | 79.2 score on a scale | Standard Deviation 19.8 |
| Cycle 2 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Emotional Functioning | 73.7 score on a scale | Standard Deviation 21.4 |
| Cycle 2 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | School Functioning | 70.5 score on a scale | Standard Deviation 25.2 |
| Cycle 2 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Physical Functioning | 65.6 score on a scale | Standard Deviation 24.1 |
| Cycle 3 - Grade 2 | Parent Proxy Quality of Life (QoL) | Physical Functioning | 74.5 score on a scale | Standard Deviation 25.6 |
| Cycle 3 - Grade 2 | Parent Proxy Quality of Life (QoL) | Emotional Functioning | 78.6 score on a scale | Standard Deviation 21 |
| Cycle 3 - Grade 2 | Parent Proxy Quality of Life (QoL) | Social Functioning | 84.5 score on a scale | Standard Deviation 20.1 |
| Cycle 3 - Grade 2 | Parent Proxy Quality of Life (QoL) | School Functioning | 80.3 score on a scale | Standard Deviation 21.7 |
| Cycle 3 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Social Functioning | 87.8 score on a scale | Standard Deviation 17.9 |
| Cycle 3 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | School Functioning | 82.2 score on a scale | Standard Deviation 22.9 |
| Cycle 3 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Emotional Functioning | 84.2 score on a scale | Standard Deviation 20.3 |
| Cycle 3 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Physical Functioning | 76.6 score on a scale | Standard Deviation 29 |
| Cycle 4 - Grade 2 | Parent Proxy Quality of Life (QoL) | Physical Functioning | 75 score on a scale | Standard Deviation 26.4 |
| Cycle 4 - Grade 2 | Parent Proxy Quality of Life (QoL) | Social Functioning | 82.5 score on a scale | Standard Deviation 22.8 |
| Cycle 4 - Grade 2 | Parent Proxy Quality of Life (QoL) | Emotional Functioning | 79 score on a scale | Standard Deviation 23.3 |
| Cycle 4 - Grade 2 | Parent Proxy Quality of Life (QoL) | School Functioning | 78.2 score on a scale | Standard Deviation 22.5 |
| Cycle 4 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Physical Functioning | 84.7 score on a scale | Standard Deviation 29.1 |
| Cycle 4 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Social Functioning | 92.6 score on a scale | Standard Deviation 13.5 |
| Cycle 4 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | Emotional Functioning | 85.5 score on a scale | Standard Deviation 19.2 |
| Cycle 4 - Grade 3-4 | Parent Proxy Quality of Life (QoL) | School Functioning | 81 score on a scale | Standard Deviation 19.4 |
Secondary
Patient Quality of Life (QoL)
Patient QOL will be measured at multiple time points to assess the patient's physical emotional, social, and school functioning. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Time frame: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment).
Population: Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by patient.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AEPA Chemotherapy | Patient Quality of Life (QoL) | Physical Functioning | 69.5 score on a scale | Standard Deviation 21.8 |
| AEPA Chemotherapy | Patient Quality of Life (QoL) | Emotional Functioning | 71.7 score on a scale | Standard Deviation 24.4 |
| AEPA Chemotherapy | Patient Quality of Life (QoL) | Social Functioning | 86.2 score on a scale | Standard Deviation 17 |
| AEPA Chemotherapy | Patient Quality of Life (QoL) | School Functioning | 65.5 score on a scale | Standard Deviation 22.7 |
| Cycle 1 - Grade 3-4 | Patient Quality of Life (QoL) | School Functioning | 75.7 score on a scale | Standard Deviation 24.3 |
| Cycle 1 - Grade 3-4 | Patient Quality of Life (QoL) | Emotional Functioning | 80.3 score on a scale | Standard Deviation 20.2 |
| Cycle 1 - Grade 3-4 | Patient Quality of Life (QoL) | Physical Functioning | 75.8 score on a scale | Standard Deviation 21.8 |
| Cycle 1 - Grade 3-4 | Patient Quality of Life (QoL) | Social Functioning | 87.2 score on a scale | Standard Deviation 18.3 |
| Cycle 2 - Grade 2 | Patient Quality of Life (QoL) | Physical Functioning | 73.9 score on a scale | Standard Deviation 24.1 |
| Cycle 2 - Grade 2 | Patient Quality of Life (QoL) | School Functioning | 75.7 score on a scale | Standard Deviation 24.7 |
| Cycle 2 - Grade 2 | Patient Quality of Life (QoL) | Emotional Functioning | 83.1 score on a scale | Standard Deviation 16.6 |
| Cycle 2 - Grade 2 | Patient Quality of Life (QoL) | Social Functioning | 88.5 score on a scale | Standard Deviation 15.9 |
| Cycle 2 - Grade 3-4 | Patient Quality of Life (QoL) | Physical Functioning | 74 score on a scale | Standard Deviation 22.1 |
| Cycle 2 - Grade 3-4 | Patient Quality of Life (QoL) | Emotional Functioning | 82.1 score on a scale | Standard Deviation 18.4 |
| Cycle 2 - Grade 3-4 | Patient Quality of Life (QoL) | Social Functioning | 90.2 score on a scale | Standard Deviation 12.4 |
| Cycle 2 - Grade 3-4 | Patient Quality of Life (QoL) | School Functioning | 79.2 score on a scale | Standard Deviation 21.5 |
| Cycle 3 - Grade 2 | Patient Quality of Life (QoL) | School Functioning | 86.9 score on a scale | Standard Deviation 18.6 |
| Cycle 3 - Grade 2 | Patient Quality of Life (QoL) | Social Functioning | 92.3 score on a scale | Standard Deviation 11.6 |
| Cycle 3 - Grade 2 | Patient Quality of Life (QoL) | Emotional Functioning | 84.8 score on a scale | Standard Deviation 19.8 |
| Cycle 3 - Grade 2 | Patient Quality of Life (QoL) | Physical Functioning | 82.5 score on a scale | Standard Deviation 23.2 |
| Cycle 3 - Grade 3-4 | Patient Quality of Life (QoL) | School Functioning | 85.4 score on a scale | Standard Deviation 16.2 |
| Cycle 3 - Grade 3-4 | Patient Quality of Life (QoL) | Social Functioning | 93.8 score on a scale | Standard Deviation 11.9 |
| Cycle 3 - Grade 3-4 | Patient Quality of Life (QoL) | Emotional Functioning | 88.4 score on a scale | Standard Deviation 18.8 |
| Cycle 3 - Grade 3-4 | Patient Quality of Life (QoL) | Physical Functioning | 87.7 score on a scale | Standard Deviation 20.3 |
| Cycle 4 - Grade 2 | Patient Quality of Life (QoL) | School Functioning | 87.2 score on a scale | Standard Deviation 13.1 |
| Cycle 4 - Grade 2 | Patient Quality of Life (QoL) | Physical Functioning | 87.1 score on a scale | Standard Deviation 20.7 |
| Cycle 4 - Grade 2 | Patient Quality of Life (QoL) | Social Functioning | 94 score on a scale | Standard Deviation 12.8 |
| Cycle 4 - Grade 2 | Patient Quality of Life (QoL) | Emotional Functioning | 88.2 score on a scale | Standard Deviation 16.4 |
| Cycle 4 - Grade 3-4 | Patient Quality of Life (QoL) | Emotional Functioning | 80.9 score on a scale | Standard Deviation 22.8 |
| Cycle 4 - Grade 3-4 | Patient Quality of Life (QoL) | Social Functioning | 95.3 score on a scale | Standard Deviation 12.2 |
| Cycle 4 - Grade 3-4 | Patient Quality of Life (QoL) | School Functioning | 81.5 score on a scale | Standard Deviation 23.1 |
| Cycle 4 - Grade 3-4 | Patient Quality of Life (QoL) | Physical Functioning | 88.8 score on a scale | Standard Deviation 19.4 |
Secondary
Response Rate
Response compared to the Euro-Net C1 after 2 cycles of AEPA.
Time frame: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Secondary
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0)
Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 3. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Time frame: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)
Population: Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by patient. The Peds QL 3.0 data was not collected on the HOD 99 patients at the T1 time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Nausea-T1 | 73.97 score on a scale | Standard Deviation 21.2 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Total Score-T2 | 80.41 score on a scale | Standard Deviation 14.68 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Nausea-T2 | 75.52 score on a scale | Standard Deviation 23.92 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Nausea-T3 | 79.66 score on a scale | Standard Deviation 20.73 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Nausea-T4 | 88.1 score on a scale | Standard Deviation 17.67 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Procedural Anxiety-T1 | 58.6 score on a scale | Standard Deviation 37 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Procedural Anxiety-T2 | 77.55 score on a scale | Standard Deviation 26.64 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Procedural Anxiety-T3 | 81.61 score on a scale | Standard Deviation 24.47 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Procedural Anxiety-T4 | 76.83 score on a scale | Standard Deviation 30.36 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Treatment Anxiety-T1 | 84.52 score on a scale | Standard Deviation 21.47 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Treatment Anxiety-T2 | 91.39 score on a scale | Standard Deviation 14.67 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Treatment Anxiety-T3 | 93.97 score on a scale | Standard Deviation 12.37 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Treatment Anxiety-T4 | 93.17 score on a scale | Standard Deviation 13.95 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Worry-T1 | 69.22 score on a scale | Standard Deviation 24.08 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Worry-T2 | 77.55 score on a scale | Standard Deviation 22.51 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Worry-T3 | 84.2 score on a scale | Standard Deviation 17.01 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Worry-T4 | 82.17 score on a scale | Standard Deviation 20.89 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Cognitive Problems-T1 | 72.34 score on a scale | Standard Deviation 23.09 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Cognitive Problems-T2 | 81.25 score on a scale | Standard Deviation 21.06 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Cognitive Problems-T3 | 84.38 score on a scale | Standard Deviation 19.41 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Cognitive Problems-T4 | 87.04 score on a scale | Standard Deviation 18.95 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Perceived Physical Appearance-T1 | 79.64 score on a scale | Standard Deviation 25.21 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Perceived Physical Appearance-T2 | 83.53 score on a scale | Standard Deviation 22.99 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Perceived Physical Appearance-T3 | 82.69 score on a scale | Standard Deviation 22.29 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Perceived Physical Appearance-T4 | 85.17 score on a scale | Standard Deviation 22.48 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Communication-T1 | 74.6 score on a scale | Standard Deviation 27.3 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Communication-T2 | 85.38 score on a scale | Standard Deviation 20.73 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Communication-T3 | 85.34 score on a scale | Standard Deviation 20.9 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Communication-T4 | 87.33 score on a scale | Standard Deviation 17.6 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Total Score-T3 | 83.33 score on a scale | Standard Deviation 13.87 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Total Score-T4 | 85.33 score on a scale | Standard Deviation 13.62 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Pain and Hurt-T1 | 73.41 score on a scale | Standard Deviation 27.45 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Pain and Hurt-T2 | 71.77 score on a scale | Standard Deviation 29.94 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Pain and Hurt-T3 | 72.63 score on a scale | Standard Deviation 30.03 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Pain and Hurt-T4 | 77.5 score on a scale | Standard Deviation 30.3 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Total Score-T1 | 73.38 score on a scale | Standard Deviation 15.97 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Total Score-T2 | 71.92 score on a scale | Standard Deviation 14.58 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Cognitive Problems-T2 | 75.72 score on a scale | Standard Deviation 19.48 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Total Score-T3 | 73.78 score on a scale | Standard Deviation 17.72 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Treatment Anxiety-T2 | 85.92 score on a scale | Standard Deviation 17.06 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Total Score-T4 | 79.92 score on a scale | Standard Deviation 16.25 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Perceived Physical Appearance-T3 | 79.87 score on a scale | Standard Deviation 22.47 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Treatment Anxiety-T3 | 85.06 score on a scale | Standard Deviation 23.11 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Pain and Hurt-T2 | 66.09 score on a scale | Standard Deviation 27.49 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Cognitive Problems-T3 | 78.38 score on a scale | Standard Deviation 22.03 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Pain and Hurt-T3 | 69.81 score on a scale | Standard Deviation 29.34 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Treatment Anxiety-T4 | 83.71 score on a scale | Standard Deviation 22.9 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Pain and Hurt-T4 | 82.2 score on a scale | Standard Deviation 25.39 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Communication-T2 | 79.02 score on a scale | Standard Deviation 18.58 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Cognitive Problems-T4 | 81.69 score on a scale | Standard Deviation 17.84 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Nausea-T2 | 60.5 score on a scale | Standard Deviation 23.83 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Worry-T2 | 64.63 score on a scale | Standard Deviation 25.01 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Nausea-T3 | 60.26 score on a scale | Standard Deviation 26.92 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Perceived Physical Appearance-T4 | 79.95 score on a scale | Standard Deviation 23.79 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Nausea-T4 | 78.13 score on a scale | Standard Deviation 22.69 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Worry-T3 | 66.45 score on a scale | Standard Deviation 25.33 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Communication-T4 | 84.24 score on a scale | Standard Deviation 21.16 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Procedural Anxiety-T2 | 71.17 score on a scale | Standard Deviation 27.72 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Worry-T4 | 69.57 score on a scale | Standard Deviation 29.58 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Procedural Anxiety-T3 | 73.46 score on a scale | Standard Deviation 27.98 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Perceived Physical Appearance-T2 | 78.07 score on a scale | Standard Deviation 24.91 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Procedural Anxiety-T4 | 77.65 score on a scale | Standard Deviation 24.2 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) | PedsQL v.3.0 Communication-T3 | 81.93 score on a scale | Standard Deviation 21.22 |
Comparison: PedsQL v.3.0 Communication-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Cognitive Problems-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.043Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Cognitive Problems-T4, completion of radiation (approximately 8 months)p-value: 0.044Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Perceived Physical Appearance-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: 0.091Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Perceived Physical Appearance-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.248Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Perceived Physical Appearance-T4, completion of radiation (approximately 8 months)p-value: 0.069Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.002Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Total Score-T4, completion of radiation (approximately 8 months)p-value: 0.067Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Pain and Hurt-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: 0.115Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Pain and Hurt-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.455Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Pain and Hurt-T4, completion of radiation (approximately 8 months)p-value: 0.636Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Nausea-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Nausea-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Nausea-T4, completion of radiation (approximately 8 months)p-value: 0.006Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Procedural Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: 0.099Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Procedural Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.05Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Procedural Anxiety-T4, completion of radiation (approximately 8 months)p-value: 0.52Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Treatment Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: 0.024Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Treatment Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.011Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Treatment Anxiety-T4, completion of radiation (approximately 8 months)p-value: 0.009Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Worry-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Worry-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Worry-T4, completion of radiation (approximately 8 months)p-value: 0.035Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Cognitive Problems-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: 0.037Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Communication-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.292Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.3.0 Communication-T4, completion of radiation (approximately 8 months)p-value: 0.429Wilcoxon (Mann-Whitney)
Secondary
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0)
Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 4. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Time frame: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)
Population: Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by patient.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Total Score-T1 | 72.94 score on a scale | Standard Deviation 17.63 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Total Score-T2 | 79.38 score on a scale | Standard Deviation 17.43 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Total Score-T3 | 80.39 score on a scale | Standard Deviation 14.96 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Total Score-T4 | 86.06 score on a scale | Standard Deviation 14.53 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Physical Functioning-T1 | 69.54 score on a scale | Standard Deviation 21.78 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Physical Functioning-T2 | 73.86 score on a scale | Standard Deviation 24.14 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Physical Functioning-T3 | 74.02 score on a scale | Standard Deviation 22.13 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Physical Functioning-T4 | 82.45 score on a scale | Standard Deviation 23.24 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Emotional Functioning-T1 | 71.75 score on a scale | Standard Deviation 24.38 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Emotional Functioning-T2 | 83.06 score on a scale | Standard Deviation 16.63 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Emotional Functioning-T3 | 82.07 score on a scale | Standard Deviation 18.43 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Emotional Functioning-T4 | 84.81 score on a scale | Standard Deviation 19.75 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Social Functioning-T1 | 86.21 score on a scale | Standard Deviation 17.05 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Social Functioning-T2 | 88.47 score on a scale | Standard Deviation 15.85 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Social Functioning-T3 | 90.22 score on a scale | Standard Deviation 12.41 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Social Functioning-T4 | 92.31 score on a scale | Standard Deviation 11.57 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 School Functioning-T1 | 65.49 score on a scale | Standard Deviation 22.72 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 School Functioning-T2 | 75.66 score on a scale | Standard Deviation 24.66 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 School Functioning-T3 | 79.2 score on a scale | Standard Deviation 21.49 |
| AEPA Chemotherapy | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 School Functioning-T4 | 86.9 score on a scale | Standard Deviation 18.62 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 School Functioning-T2 | 66.91 score on a scale | Standard Deviation 21.79 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Total Score-T1 | 72.48 score on a scale | Standard Deviation 17.37 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Emotional Functioning-T3 | 75.06 score on a scale | Standard Deviation 22.38 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Total Score-T2 | 73.54 score on a scale | Standard Deviation 16.71 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Social Functioning-T4 | 91.44 score on a scale | Standard Deviation 14.35 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Total Score-T3 | 77.68 score on a scale | Standard Deviation 17.25 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Emotional Functioning-T4 | 80.87 score on a scale | Standard Deviation 20.63 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Total Score-T4 | 84.58 score on a scale | Standard Deviation 15.02 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 School Functioning-T4 | 79.32 score on a scale | Standard Deviation 17.77 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Physical Functioning-T1 | 70.41 score on a scale | Standard Deviation 26.09 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Social Functioning-T1 | 86.22 score on a scale | Standard Deviation 17.69 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Physical Functioning-T2 | 70.06 score on a scale | Standard Deviation 22.73 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 School Functioning-T1 | 67.82 score on a scale | Standard Deviation 19.65 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Physical Functioning-T3 | 72.94 score on a scale | Standard Deviation 25.25 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Social Functioning-T2 | 86.82 score on a scale | Standard Deviation 15.42 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Physical Functioning-T4 | 83.57 score on a scale | Standard Deviation 18.86 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 School Functioning-T3 | 69.1 score on a scale | Standard Deviation 24.27 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Emotional Functioning-T1 | 67.18 score on a scale | Standard Deviation 18.25 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Social Functioning-T3 | 88.86 score on a scale | Standard Deviation 13.84 |
| Cycle 1 - Grade 3-4 | To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) | PedsQL v.4.0 Emotional Functioning-T2 | 71.31 score on a scale | Standard Deviation 20.96 |
Comparison: PedsQL v.4.0 Total Score-T1, At Diagnosis (baseline)p-value: 0.975Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: 0.032t-test, 2 sided
Comparison: PedsQL v.4.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.497Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Total Score-T4, completion of radiation (approximately 8 months)p-value: 0.399Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Physical Functioning-T1, At Diagnosis (baseline)p-value: 0.451Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Physical Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: 0.198Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Physical Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.967Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Physical Functioning-T4, completion of radiation (approximately 8 months)p-value: 0.647Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Emotional Functioning-T1, At Diagnosis (baseline)p-value: 0.145Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Emotional Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Emotional Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.073Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Emotional Functioning-T4, completion of radiation (approximately 8 months)p-value: 0.156Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Social Functioning-T1, At Diagnosis (baseline)p-value: 0.844Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Social Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: 0.206Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Social Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.491Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 Social Functioning-T4, completion of radiation (approximately 8 months)p-value: 0.906Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 School Functioning-T1, At Diagnosis (baseline)p-value: 0.58Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 School Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)p-value: 0.012Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 School Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)p-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: PedsQL v.4.0 School Functioning-T4, completion of radiation (approximately 8 months)p-value: 0.005Wilcoxon (Mann-Whitney)