Hodgkin Lymphoma, Adult
Conditions
Keywords
Hodgkin's lymphoma, Hodgkin lymphoma
Brief summary
The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4 chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive radiation therapy. The use of chemotherapy and radiation may cause long term treatment related side effects such as heart problems and other cancers. Researchers are trying to find if combining ABVD chemotherapy with new drugs and reducing the number of ABVD chemotherapy cycles given is just as effective as the standard Hodgkin treatment. Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study, the use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered investigational. Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it. Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of the brentuximab vedotin sticks to a target called cluster of differentiation antigen 30 (CD30). CD30 is an important molecule on some cancer cells and some normal cells of the immune system. The purpose of this research study is to see the effects of treatment with fewer cycles of the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on study participants and Hodgkins lymphoma.
Detailed description
This study is designed as a single arm pilot feasibility trial using an induction of 2-6 cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) chemotherapy followed by 6 cycles of brentuximab vedotin (SGN-35) consolidation for previously untreated patients with stage I and II non-bulky Hodgkin Lymphoma (HL). Feasibility will be determined by the percentage of patients who have no clinical evidence of HL, and achieve positron emission tomograph (PET) negative disease post brentuximab consolidation. We anticipate approximately 40 patients will be eligible across participating centers (including UNC, Mayo Clinic, and the UNC Cancer Network (UNCCN)) over a 2 year period. A future phase II study evaluating progression free survival (PFS) after ABVD followed by brentuximab vedotin will be considered feasible if ≥ 13 of 15 patients enrolled in this pilot trial become PET negative after brentuximab vedotin consolidation.
Interventions
DRUGBrentuximab vedotin
IV, 1.8mg/kg, every 3 weeks for 6 cycles.
DRUGABVD
Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles. Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles. Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Sponsors
Seagen Inc.
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Previously untreated stage I or II non-bulky Hodgkin lymphoma * No mediastinal mass \>0.33 maximum intrathoracic diameter on chest x-ray (see Appendix B) * No adenopathy ≥7.5 cm in its largest diameter * Measurable disease as assessed by 2 dimensional measurement by CT (\>2cm or 1.5 cm if 0.5 cm slices are used, as in spiral CT scan) * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Age ≥18 years and ≤60 years of age * Life expectancy of at least 3 months * Adequate bone marrow function (without transfusion support within one week of screening) as demonstrated by: * Hemoglobin ≥ 8 g/dL * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 * Platelet count ≥ 75,000/mm3 * Adequate hepatic and renal function as demonstrated by: * Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) * Total serum bilirubin ≤1.5 x ULN * Serum creatinine ≤ 2.0 mg/dL * Negative serum human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours of day 1 of treatment with ABVD in women of child-bearing potential * Females of childbearing potential, and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of brentuximab vedotin. Effective contraception is defined as any medically recommended method (or combination of methods) as per standard of care, including abstinence. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. * Signed an institutional review board (IRB)-approved informed consent document for this protocol Prior to Day 1 of brentuximab vedotin, patients must again meet the following inclusion criteria: * Adequate bone marrow function (without transfusion support within one week of D1 of brentuximab vedotin) as demonstrated by: * Hemoglobin ≥ 8 g/dL * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 * Platelet count ≥ 75,000/mm3 * Adequate hepatic and renal function as demonstrated by: * Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) * Total serum bilirubin ≤1.5 x ULN * Serum creatinine ≤ 2.0 mg/dL * Achieved at least a partial response (PR) (and not progressed) after ABVD therapy
Exclusion criteria
* Prior therapies for treatment of HL including involved field radiation therapy or any prior treatment for any malignancy with anthracyclines. * Bulky disease (defined as a mass measuring \> 7.5 cm or one-third the maximal diameter of the thoracic cavity) * Known central nervous system (CNS) involvement * Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators * Known history of human immunodeficiency virus (HIV), hepatitis B and hepatitis C (testing is not necessary if patient does not have history of these diseases, and no risk factors for acquisition of these viruses) * Cardiac disease with left ventricular ejection fraction of less than 45% * Known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD * Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective * Other active malignancies with the exception of: * Non-melanoma skin cancer * Cervical carcinoma in situ without evidence of disease * Prostatic intraepithelial neoplasia without evidence of prostate cancer * Pregnant or lactating women Prior to Day 1 of brentuximab vedotin, please verify the patient does not meet the criteria below: * Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Positron Emission Tomography (PET) Negative Disease | 12 months | Percentage of patients who convert to PET negative disease post consolidation. This is defined by PET with Deauville \<=2. The Deauville 5-point scoring system is a five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG Positron emission tomography: Score 1: No uptake above the background Score 2: Uptake ≤ mediastinum Score 3: Uptake \> mediastinum but ≤ liver Score 4: Uptake moderately increased compared to the liver at any site Score 5: Uptake markedly increased compared to the liver at any site Score X: New areas of uptake unlikely to be related to lymphoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant Who Achieved a Complete Response | 12 months | Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas. Complete Response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. |
| Conversion Rate to Complete Response. Number of Participants Who Had a Partial Response Post ABVD Who Converted to a Complete Response. | 12 months | Conversion rate to Complete Response after brentuximab vedotin in patients with partial response at the end of ABVD therapy. Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas. Complete Response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least 2 perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved. |
| 3 Year Progression Free Survival Rate | 3 years | Defined as the percentage of participants who did not show relapse/progression or death from any cause occurred at 3 years after the time from ABVD treatment start. Relapse/progression is measured using the Revised Response Criteria for Malignant Lymphoma and is defined as the following: appearance of any new lesion \> 1.5 centimeters (cm) in any axis during or at the end of therapy; at least a 50% increase from nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions; or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis. In addition, lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was positron emission tomography (PET) positive before therapy |
| 3 Year Time to Progression Rate | 3 years | Defined as the percentage of participants who did not show relapse/progression at 3 years after the time from ABVD treatment start. Relapse/progression is measured using the Revised Response Criteria for Malignant Lymphoma and is defined as the following: appearance of any new lesion \> 1.5 centimeters (cm) in any axis during or at the end of therapy; at least a 50% increase from nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions; or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis. In addition, lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was positron emission tomography (PET) positive before therapy |
| Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | 12 months | Number of adverse events attributed to Brentuximab Vedotin with a grade 3 or higher. Toxicity assessed via the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.The higher the grade the more severe the adverse event. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ABVD Followed by Brentuximab Vedotin Single arm trial
Brentuximab vedotin: IV, 1.8mg/kg, every 3 weeks for 6 cycles.
ABVD: Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | ABVD Followed by Brentuximab Vedotin |
|---|---|
| Age, Continuous | 29 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 40 participants |
| Risk Favorable | 18 Participants |
| Risk UnFavorable | 22 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 17 Participants |
| Stage I | 2 Participants |
| Stage IIA | 28 Participants |
| Stage IIB | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 41 |
| other Total, other adverse events | 41 / 41 |
| serious Total, serious adverse events | 6 / 41 |
Outcome results
Primary
Percentage of Patients With Positron Emission Tomography (PET) Negative Disease
Percentage of patients who convert to PET negative disease post consolidation. This is defined by PET with Deauville \<=2. The Deauville 5-point scoring system is a five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG Positron emission tomography: Score 1: No uptake above the background Score 2: Uptake ≤ mediastinum Score 3: Uptake \> mediastinum but ≤ liver Score 4: Uptake moderately increased compared to the liver at any site Score 5: Uptake markedly increased compared to the liver at any site Score X: New areas of uptake unlikely to be related to lymphoma
Time frame: 12 months
Population: One patient was not evaluable due to change in diagnosis during ABVD treatment (HL --\> gray zone lymphoma). There was one death due to sepsis and hepatic failure, a very rare but known complication of brentuximab vedotin. Leaving 39 evaluable patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABVD Followed by Brentuximab Vedotin | Percentage of Patients With Positron Emission Tomography (PET) Negative Disease | 37 Participants |
Secondary
3 Year Progression Free Survival Rate
Defined as the percentage of participants who did not show relapse/progression or death from any cause occurred at 3 years after the time from ABVD treatment start. Relapse/progression is measured using the Revised Response Criteria for Malignant Lymphoma and is defined as the following: appearance of any new lesion \> 1.5 centimeters (cm) in any axis during or at the end of therapy; at least a 50% increase from nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions; or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis. In addition, lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was positron emission tomography (PET) positive before therapy
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABVD Followed by Brentuximab Vedotin | 3 Year Progression Free Survival Rate | 92 percentage of patients progression free |
Secondary
3 Year Time to Progression Rate
Defined as the percentage of participants who did not show relapse/progression at 3 years after the time from ABVD treatment start. Relapse/progression is measured using the Revised Response Criteria for Malignant Lymphoma and is defined as the following: appearance of any new lesion \> 1.5 centimeters (cm) in any axis during or at the end of therapy; at least a 50% increase from nadir in the sum of the product of the diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions; or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis. In addition, lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was positron emission tomography (PET) positive before therapy
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABVD Followed by Brentuximab Vedotin | 3 Year Time to Progression Rate | 92 percentage of patients progression free |
Secondary
Conversion Rate to Complete Response. Number of Participants Who Had a Partial Response Post ABVD Who Converted to a Complete Response.
Conversion rate to Complete Response after brentuximab vedotin in patients with partial response at the end of ABVD therapy. Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas. Complete Response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least 2 perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.
Time frame: 12 months
Population: 4 subjects had a partial response (PR) (Deauville score of 3)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABVD Followed by Brentuximab Vedotin | Conversion Rate to Complete Response. Number of Participants Who Had a Partial Response Post ABVD Who Converted to a Complete Response. | 3 Participants |
Secondary
Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher
Number of adverse events attributed to Brentuximab Vedotin with a grade 3 or higher. Toxicity assessed via the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.The higher the grade the more severe the adverse event.
Time frame: 12 months
Population: Please note all grade 4 or higher events were experienced by one patient. The patient developed fever and hepatic dysfunction after 1 dose of Brentuximab Vedotin (BV). Patient also developed pancreatitis and eventually died of sepsis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Aspartate aminotransferase increased | 1 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | White blood cell decreased | 0 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Pancreatitis | 0 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Blood bilirubin increased | 0 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Rash maculo-papular | 1 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Lipase increased | 0 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Infections and infestations | 1 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Hypophosphatemia | 1 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Hepatic failure | 0 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Hyperglycemia | 1 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Syncope | 1 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Creatinine increased | 1 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Alanine aminotransferase increased | 1 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Sepsis | 0 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Pleural effusion | 0 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Anemia | 1 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Renal and urinary disorders | 0 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Platelet count decreased | 0 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Ascites | 0 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Neutropenia | 3 Number of events |
| ABVD Followed by Brentuximab Vedotin | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Peripheral sensory neuropathy | 1 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Pleural effusion | 1 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Hepatic failure | 1 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Neutropenia | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Infections and infestations | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Alanine aminotransferase increased | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Anemia | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Ascites | 1 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Aspartate aminotransferase increased | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Blood bilirubin increased | 1 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Creatinine increased | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Hyperglycemia | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Hypophosphatemia | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Lipase increased | 1 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Pancreatitis | 1 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Peripheral sensory neuropathy | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Platelet count decreased | 1 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Rash maculo-papular | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Renal and urinary disorders | 1 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Sepsis | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Syncope | 0 Number of events |
| Grade 4 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | White blood cell decreased | 1 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Sepsis | 1 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Peripheral sensory neuropathy | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Anemia | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Syncope | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Platelet count decreased | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Alanine aminotransferase increased | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Infections and infestations | 1 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Pleural effusion | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Neutropenia | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Lipase increased | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Rash maculo-papular | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Hyperglycemia | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Creatinine increased | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | White blood cell decreased | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Hypophosphatemia | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Blood bilirubin increased | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Hepatic failure | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Aspartate aminotransferase increased | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Renal and urinary disorders | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Pancreatitis | 0 Number of events |
| Grade 5 | Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher | Ascites | 0 Number of events |
Secondary
Number of Participant Who Achieved a Complete Response
Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas. Complete Response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
Time frame: 12 months
Population: One patient was not evaluable due to change in diagnosis during ABVD treatment (HL --\> gray zone lymphoma). There was one death due to sepsis and hepatic failure, a very rare but known complication of brentuximab vedotin. Leaving 39 evaluable patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABVD Followed by Brentuximab Vedotin | Number of Participant Who Achieved a Complete Response | 37 Participants |