drugset / Trial / NCT00003215

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma

NCT00003215 ↗

Phase 3 Completed 400 enrolled Swiss Cancer Institute
RandomizedTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with more than one drug regimen may kill more tumor cells. It is not known whether receiving standard combination chemotherapy alone is more effective than receiving multiple combination chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-Hodgkin's lymphoma.

Timeline

Start
1997-04
Primary completion
2004-03
Completion
2004-03

Outcome

Missed primary endpoint

paper there was no difference in overall survival at 3 years, with 46% for SHiDo and 53% for CHOP (P = 0.48). PMID 16888080 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Doxorubicin Other / unclassified — Intravenous
Subject Etoposide Small molecule — Intravenous
Subject Melphalan Small molecule — Intravenous
Subject Methotrexate Small molecule — Intravenous
Subject Methylprednisolone Other / unclassified — Intravenous
Subject Mitoxantrone Small molecule — Intravenous
Subject Prednisone Other / unclassified — Oral
Subject Vincristine Small molecule — Intravenous
Background Cytarabine Small molecule — Intrathecal
Background Hydrocortisone Other / unclassified — Intrathecal
Background Leucovorin Small molecule — Intravenous
Background filgrastim Protein / enzyme biologic — Subcutaneous

Indications