Lymphoma
Conditions
Keywords
recurrent adult Hodgkin lymphoma
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well tandem stem cell transplantation works in treating patients with progressive or recurrent Hodgkin's lymphoma.
Detailed description
OBJECTIVES: * Determine the 2-year progression-free survival of patients with progressive or recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation (2 courses of high-dose therapy with autologous stem cell rescue). * Determine the response rate in patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. * Salvage therapy (for patients with relapsed disease after achieving a previous complete response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy. No more than 6 weeks later, patients proceed to autologous hematopoietic stem cell collection. * Autologous hematopoietic stem cell collection: Patients undergo autologous hematopoietic stem cell collection. Patients with an inadequate number of collected stem cells are removed from the study. * Pre-transplant salvage radiation: Patients with residual tumor greater than 5 cm after initial salvage therapy undergo involved-field radiotherapy. All patients then proceed to the first preparative regimen. * First preparative regimen: Patients receive high-dose melphalan IV on day -1. * First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on day 0. At least 28 days later, patients proceed to second preparative regimen. * Second preparative regimen: Patients receive 1 of the following preparative regimens: * Total-body irradiation (TBI)-based regimen: Patients undergo TBI twice daily on days -8 to -5. Patients also receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2. * Carmustine-based regimen: Patients receive carmustine IV over 2 hours on days -6 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2. * Second autologous SCT: Patients undergo second autologous SCT on day 0. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 7 years. PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study over 2 years.
Interventions
DRUGcarmustine
150 mg/m\^2 IV over 2 hours 4, 5, and 6 days before transplant.
DRUGcyclophosphamide
100 mg/kg IV 2 days before transplant.
DRUGetoposide
60 mg/kg IV over 4 hours 4 days before transplant.
DRUGmelphalan
150 mg/m\^2 IV 1 day before transplant.
2.0 x 10\^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.
RADIATIONradiation therapy
150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed Hodgkin's lymphoma * Relapsed or refractory disease * Biopsy or radiological evidence of disease at time of recurrence/progression required * Has received ≥ 1 prior systemic chemotherapy regimen * No clonal abnormalities in marrow collection * Must undergo involved-field radiotherapy if bulky disease \> 5 cm * Must have adequate sections of original diagnostic specimen available for review * Needle aspirations or cytologies are not adequate * No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free \> 5 years) * Patients who relapse after achieving a complete remission must complete a minimum of 2 courses of salvage chemotherapy or radiation therapy to determine if sensitive or resistant recurrent disease is present * No central nervous system (CNS) involvement PATIENT CHARACTERISTICS: Age * 15 to 70 Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Hodgkin's disease) Renal * Creatinine clearance ≥ 60 mL/min * Creatinine ≤ 2 times upper limit of normal Cardiovascular * None of the following conditions requiring therapy: * Coronary artery disease * Cardiomyopathy * Congestive heart failure * Arrhythmias * Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram Pulmonary * Adequate pulmonary function * Corrected diffusing capacity of lung for carbon monoxide (DLCO) ≥ 60% OR * Forced Expiratory Volume in One Side (FEV\_1) ≥ 60% of predicted Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer * No known HIV or AIDS infection * No active bacterial, fungal, or viral infection * No medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Progression-free Survival | At day 60, then every 6 months for 2 years | Measured from date of randomization to date of first observation of progressive disease, or death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | At day 60, then every 6 months for 2 years | Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. |
| Overall Survival | At day 60, then every 6 months for 2 years, then annually for a total of 7 years | Measured from date of registration to date of death due to any cause or last contact |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High-dose Therapy Plus Tandem Transplant Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells. | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Eligible but No Treatment Received | 2 |
| Overall Study | Ineligible | 4 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Other - Not Protocol Specified | 5 |
| Overall Study | Reason Under Review | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | High-dose Therapy Plus Tandem Transplant |
|---|---|
| Age, Continuous | 34.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 7 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 | 4 Participants |
| Race (NIH/OMB) White | 77 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 88 / 90 |
| serious Total, serious adverse events | 2 / 90 |
Outcome results
Primary
2-year Progression-free Survival
Measured from date of randomization to date of first observation of progressive disease, or death due to any cause
Time frame: At day 60, then every 6 months for 2 years
Population: All eligible patients who started treatment were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High-dose Therapy Plus Tandem Transplant | 2-year Progression-free Survival | 59 percentage of participants |
Secondary
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time frame: Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
Population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 4 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 47 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 3 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 6 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 2 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 22 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Nose | 2 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage/Bleeding-Other (Specify) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 10 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 4 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Foreign body | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 3 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Rectum | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Sinus | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Stomach | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Blood | 2 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Catheter | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Blood | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Skin (cellulitis) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection-Other (Specify) | 5 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 65 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphatics-Other (Specify) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 50 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Magnesium, serum-high (hypermagnesemia) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 2 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Oral cavity | 9 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Pharynx | 8 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 6 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Pharynx | 10 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 32 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 67 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Opportunistic inf associated w/gt=Gr 2 lymphopenia | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 2 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Joint | 2 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Oral cavity | 2 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Throat/pharynx/larynx | 3 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-Other (Specify) | 2 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 25 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 70 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 3 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 13 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pruritus/itching | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Psychosis (hallucinations/delusions) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pulmonary hypertension | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 4 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | SVT and nodal arrhythmia - SVT tachycardia | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 11 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syndromes-Other (Specify) | 2 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 2 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Uric acid, serum-high (hyperuricemia) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 12 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 6 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 4 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction/hypersensitivity | 3 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 20 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bilirubin (hyperbilirubinemia) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Calcium, serum-low (hypocalcemia) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colitis, infectious (e.g., Clostridium difficile) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Confusion | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constitutional Symptoms-Other (Specify) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cough | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 6 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dermatology/Skin-Other (Specify) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 8 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Distention/bloating, abdominal | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dry mouth/salivary gland (xerostomia) | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dysphagia (difficulty swallowing) | 6 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 5 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema: limb | 1 Participants |
| High-dose Therapy Plus Tandem Transplant | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Esophagitis | 5 Participants |
Secondary
Overall Survival
Measured from date of registration to date of death due to any cause or last contact
Time frame: At day 60, then every 6 months for 2 years, then annually for a total of 7 years
Population: All eligible patients who started treatment were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High-dose Therapy Plus Tandem Transplant | Overall Survival | 91 percentage of participants |
Secondary
Response Rate
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Time frame: At day 60, then every 6 months for 2 years
Population: All eligible patients who started treatment were included in the analysis. Five patients with no evidence of disease at baseline were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-dose Therapy Plus Tandem Transplant | Response Rate | Complete Response | 15 participants |
| High-dose Therapy Plus Tandem Transplant | Response Rate | Partial Response | 8 participants |
| High-dose Therapy Plus Tandem Transplant | Response Rate | Unconfirmed Complete Response | 3 participants |
| High-dose Therapy Plus Tandem Transplant | Response Rate | Unconfirmed Partial Response | 2 participants |
| High-dose Therapy Plus Tandem Transplant | Response Rate | No Response | 33 participants |
| High-dose Therapy Plus Tandem Transplant | Response Rate | Assessment Inadequate | 26 participants |