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Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
This study is currently recruiting patients.
Sponsored by: | German Low Grade Lymphoma Study Group
European Organization for Research and Treatment of Cancer
Gruppo Italiano Studio Linfomi
Groupe d'Etudes de Lymphomes de L'Adulte
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether chemotherapy combined with radiation therapy and peripheral stem cell transplantation is more effective than chemotherapy followed by interferon alfa in treating mantle cell lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by radiation therapy, chemotherapy, and peripheral stem cell transplantation with that of chemotherapy plus interferon alfa in treating patients who have stage III or stage IV mantle cell lymphoma.
Condition | Treatment or Intervention | Phase |
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stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: etoposide Drug: filgrastim Drug: interferon alfa Drug: melphalan Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: chemotherapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Procedure: high-dose chemotherapy Procedure: interferon therapy Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase III |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Intensified Chemotherapy Followed By Myeloablative Radiochemotherapy and Peripheral Blood Stem Cell Transplantation Versus Standard Therapy and Interferon alfa Maintenance in Patients With Previously Untreated Advanced Mantle Cell Lymphoma
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk factors (ECOG performance status greater than 1, LDH serum level above normal, and/or extranodal lymphoma involvement) and participating center. Patients are randomized to 1 of 2 treatment arms.
Arm I
Arm II
PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study within 5 years.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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