A Phase 3 interventional study of filgrastim and carmustine in Lymphoma, sponsored by German Hodgkin's Lymphoma Study Group. Status unknown at 44 sites in 8 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-09-17.
Sponsored by German Hodgkin's Lymphoma Study Group · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, type of relapse (early first relapse [remission duration 3-12 months] vs late first relapse [remission duration more than 12 months] vs second relapse without prior high-dose chemotherapy salvage [remission duration after salvage at least 3 months]), disease status at relapse (stage I or II vs stage III or IV), age (18 to 49 vs 50 to 60), and response after 2 courses of study induction chemotherapy (complete remission vs partial remission vs no change).
All patients receive induction chemotherapy comprising dexamethasone IV over 30 minutes on days 1-4 and 15-18, cisplatin IV continuously over 24 hours on days 1 and 15, cytarabine IV over 3 hours every 12 hours on days 2 and 16, and filgrastim (G-CSF) subcutaneously (SC) once daily on days 5-12 and days 19-26. Patients with complete remission (CR), unconfirmed CR, partial remission, or no change are randomized to one of two treatment arms.
Patients with residual lymphoma at 100 days after completion of BEAM chemotherapy may receive radiotherapy.
Patients are followed at 100 days after PBSC transplantation, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 220 patients (110 per treatment arm) will be accrued for this study within 5 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 220 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →This is the only study on the registry with German Hodgkin's Lymphoma Study Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Early or late first relapse
Second relapse
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Efficacy at 3 months
Toxicity at 3 months
Complete remission at 3 months
Relapse-free survival at 3 months
Overall survival at 3 months
This study is status unknown, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.
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