Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

Sponsor
EBMT Solid Tumors Working Party
Study ID
NCT00005589
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • carmustine — DRUG
  • cyclophosphamide — DRUG
  • cytarabine — DRUG
  • etoposide — DRUG
  • melphalan — DRUG
  • bone marrow ablation with stem cell support — PROCEDURE
  • peripheral blood stem cell transplantation — PROCEDURE

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.

Key Dates

Start date
Oct 31, 1999
Status verified
Mar 2007
Completion
Apr 30, 2013

Study Design

Enrollment
460 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Time to disease progression

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