SWOG clinical trial number
S9901

A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients with Advanced Stage Poor Prognosis Hodgkin’s Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin’s Disease, Intergroup

Closed
Phase
Accrual
3%
Abbreviated Title
HODGKIN'S: ABVD vs ABVD + high dose therapy + PBSC support
Activated
04/15/2000
Closed
11/01/2001
Participants
NCORP, Members, Medical Oncologists, Pathologists, ECOG, CALGB

Research committees

Lymphoma

Treatment

Cyclophosphamide BCNU Bleomycin Doxorubicin DTIC Vinblastine Sulfate VP-16 ABVD

Eligibility Criteria Expand/Collapse

Biopsy proven Hodgkin's Disease (HD), Stage III or IV; MUST HAVE 3 or more of the following poor prognostic factors at the time of diagnosis: (albumin < 4.0 mg/dl, hemoglobin < 10.5 mg/dl, leukocytosis > = 15,000/mm3, lymphocytopenia < 600/mm3 or < 8% of total WBC, male sex, age > = 45 years, Stage IV disease); no prior chemotherapy for HD except for one cycle of ABVD prior to registration (if so, reg. must occur within 35 days of the start of the first cycle of ABVD and all eligibility requirements for first registration must have been completed prior to the first cycle of ABVD); no prior RT for HD; bone marrow aspirate and biopsy; chest x-ray; CT scan; bidimensionally measureable disease; no central nervous system involvement by HD; no non-lymphoma related hepatic and/or renal dysfunction; WBC; LDH; no coronary artery disease, cardiomyopathy, congestive heart failure or arrhythmias; EKG; corrected DLCO or FEV1 > = 60% of predicted; age > = 15 years and < = 65 years; no known HIV or AIDS; potential BMT transplant center must be notified.