Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplant Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma

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.

Conditions

• Lymphoma

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

recombinant interferon alfa

DRUG

carmustine

DRUG

cyclophosphamide

DRUG

cytarabine

DRUG

dexamethasone

DRUG

etoposide

DRUG

melphalan

PROCEDURE

bone marrow ablation with stem cell support

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• Gruppo Italiano Studio Linfomi

  collaborator OTHER

• Lymphoma Study Association

  collaborator OTHER

• German Low Grade Lymphoma Study Group

  lead OTHER

Principal Investigators

• Wolfgang Hiddemann, MD, PhD · Klinikum der Universitaet Muenchen - Grosshadern Campus

• J. C. Kluin-Nelemans, MD, PhD · University Medical Center Groningen

• Alessandro Levis, MD · Ospedale Civile Alessandria

• Achiel Van Hoof, MD · AZ Sint-Jan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-12-31

Countries

• Belgium
• Italy

Study Locations