Treatment of Mantle Cell Lymphomas at Advanced Stages: Prospective Randomized Comparison of Myeloablative Radiochemotherapy Followed by Blood Stem Cell Transplantation Versus Maintenance With Interferon Alpha in First Remission After Initial Cytoreductive Chemotherapy With an Anthracycline Containing Combination
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Locations
- 4
Study Overview
Brief Summary
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill cancer cells. Peripheral stem cell transplant 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 giving more than one drug (combination chemotherapy) with radiation therapy and peripheral stem cell transplant is more effective than chemotherapy followed by interferon alfa in treating mantle cell lymphoma.
PURPOSE: This randomized phase III trial compares how well chemotherapy followed by radiation therapy, chemotherapy, and peripheral stem cell transplant works compared to chemotherapy plus interferon alfa in treating patients who have stage III or stage IV mantle cell lymphoma.
Detailed Description
OBJECTIVES:
- Compare the disease-free survival of patients with previously untreated advanced mantle cell lymphoma treated with intensified chemotherapy followed by myeloablative radiochemotherapy and peripheral blood stem cell transplantation (PBSCT) vs standard therapy and interferon alfa maintenance.
- Compare the overall survival of patients treated with early vs late myeloablative radiochemotherapy and PBSCT.
- Compare disease-free survival and overall survival of patients treated with this regimen vs historic controls of similar cases.
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.
- Induction: All patients receive 4 courses of cytoreductive chemotherapy comprising an anthracycline-containing combination. Patients not achieving complete remission after 4 courses receive 2 additional courses of induction chemotherapy. Patients without at least a partial response after 6 courses discontinue treatment; those with at least a partial response proceed to arm I or II.
Arm I
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage III or IV mantle cell lymphoma
- •Previously untreated
- •Not qualified for primary potentially curative radiotherapy
- •PATIENT CHARACTERISTICS:
- •18 to 65 years
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •No impairment of liver function (unless due to lymphoma)
- •Transaminases no greater than 3 times normal
- •Bilirubin no greater than 2.0 mg/dL
- •No renal insufficiency
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No manifest heart failure or coronary heart disease
- •No severe uncontrolled hypertension
- •No chronic lung disease with hypoxemia
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No severe uncontrolled diabetes mellitus
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior interferon
- •No prior organ, bone marrow, or peripheral blood stem cell transplantation
- •Chemotherapy:
- •No prior cytostatic chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy
- •Not specified
Exclusion Criteria
- Not provided