Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
- Sponsor
- Commissie Voor Klinisch Toegepast Onderzoek
- Study ID
- NCT00012051
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- filgrastim — BIOLOGICAL
- rituximab — BIOLOGICAL
- carmustine — DRUG
- cisplatin — DRUG
- cytarabine — DRUG
- dexamethasone — DRUG
- etoposide — DRUG
- ifosfamide — DRUG
- melphalan — DRUG
- methotrexate — DRUG
- bone marrow ablation with stem cell support — PROCEDURE
- peripheral blood stem cell transplantation — PROCEDURE
- radiation therapy — RADIATION
Study Details
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by the chemotherapy. Monoclonal antibodies, such as rituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known if giving more than one drug (combination chemotherapy) plus peripheral stem cell transplant is more effective with or without monoclonal antibody therapy in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying how well chemotherapy plus peripheral stem cell transplant with or without monoclonal antibody therapy works in treating patients with relapsed non-Hodgkin's lymphoma.
Key Dates
- Start date
- Sep 30, 2000
- Status verified
- Mar 2007
- Completion
- Oct 31, 2007
Study Design
- Enrollment
- 340 participants (estimated)
- Allocation
- RANDOMIZED
- Primary purpose
- TREATMENT
Primary Outcome Measure
Overall survival
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