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

This study is currently recruiting patients.

Sponsors and Collaborators: German Low Grade Lymphoma Study Group
European Organization for Research and Treatment of Cancer
Gruppo Italiano Studio Linfomi
Groupe d'Etudes de Lymphomes de L'Adulte
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation 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 chemotherapy combined with radiation therapy and peripheral stem cell transplantation is more effective than chemotherapy followed by interferon alfa in treating mantle cell lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by radiation therapy, chemotherapy, and peripheral stem cell transplantation with that of chemotherapy plus interferon alfa in treating patients who have stage III or stage IV mantle cell lymphoma.

Condition Treatment or Intervention Phase
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: dexamethasone
 Drug: etoposide
 Drug: filgrastim
 Drug: interferon alfa
 Drug: melphalan
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: interferon therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: radiation therapy
Phase III

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Intensified Chemotherapy Followed By Myeloablative Radiochemotherapy and Peripheral Blood Stem Cell Transplantation Versus Standard Therapy and Interferon alfa Maintenance in Patients With Previously Untreated Advanced Mantle Cell Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk factors (ECOG performance status greater than 1, LDH serum level above normal, and/or extranodal lymphoma involvement) and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Induction: All patients receive 4 courses of cytoreductive chemotherapy comprising an anthracycline-containing combination. Patients not achieving complete remission after 4 courses receive 2 additional courses of induction chemotherapy. Patients without at least a partial response after 6 courses discontinue treatment; those with at least a partial response proceed to arm I or II.

Arm I

Arm II

PROJECTED ACCRUAL: A total of 210 patients will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV mantle cell lymphoma
  • Previously untreated
  • Not qualified for primary potentially curative radiotherapy

PATIENT CHARACTERISTICS: Age:

  • 18 to 65 years

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No impairment of liver function (unless due to lymphoma)
  • Transaminases no greater than 3 times normal
  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • No renal insufficiency
  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No manifest heart failure or coronary heart disease
  • No severe uncontrolled hypertension

Pulmonary:

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No severe uncontrolled diabetes mellitus

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

  • No prior cytostatic chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified

Location and Contact Information


Belgium
      AZ Sint-Jan, Brugge,  8000,  Belgium; Recruiting
Achiel Van Hoof, MD  32-50-45-23-10    achiel.vanhoof@azbrugge.be 

Italy
      Ospedale Civile Alessandria, Alessandria,  I-15100,  Italy; Recruiting
Alessandro Levis, MD  39-131-206-262    alevis@ospedale.al.it 

Study chairs or principal investigators

Wolfgang Hiddemann, MD, PhD,  Study Chair,  Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen   
J. C. Kluin-Nelemans, MD, PhD,  Study Chair,  University Medical Center Groningen   
Alessandro Levis, MD,  Study Chair,  Ospedale Civile Alessandria   
Achiel Van Hoof, MD,  Study Chair,  AZ Sint-Jan   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068609; GER-LGLSG-INTERGROUP-20995; EORTC-20995; GELA-INTERGROUP-20995; GISL-INTERGROUP-20995; NCT00016887
Record last reviewed:  September 2003
Last Updated:  April 4, 2005
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00016887
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005