drugset / Trial / NCT00012051

Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

NCT00012051

Phase 3 Completed 340 enrolled Commissie Voor Klinisch Toegepast Onderzoek
RandomizedTreatment

Summary

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.

Timeline

Start
2000-09
Primary completion
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody Intravenous
Background Cisplatin Other / unclassified Intravenous
Background Cytarabine Small molecule Intravenous
Background Dexamethasone Small molecule Oral
Background Etoposide Small molecule Intravenous
Background Ifosfamide Small molecule Intravenous
Background Melphalan Small molecule Intravenous
Background Methotrexate Small molecule Intravenous
Background carmustine Small molecule Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous

Indications