Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 65 years	Other	GER-LGLSG-INTERGROUP-20995 EORTC-20995, GELA-INTERGROUP-20995, GISL-INTERGROUP-20995, NCT00016887

Objectives

1. Compare the disease-free survival of patients with previously untreated advanced mantle cell lymphoma treated with intensified chemotherapy followed by myeloablative radiochemotherapy and peripheral blood stem cell transplantation (PBSCT) vs standard therapy and interferon alfa maintenance.
2. Compare the overall survival of patients treated with early vs late myeloablative radiochemotherapy and PBSCT.
3. Compare disease-free survival and overall survival of patients treated with this regimen vs historic controls of similar cases.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage III or IV mantle cell lymphoma
  • Previously untreated



• Not qualified for primary potentially curative radiotherapy

Prior/Concurrent Therapy:

Biologic therapy:

• No prior interferon
• No prior organ, bone marrow, or peripheral blood stem cell transplantation

Chemotherapy:

• No prior cytostatic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified

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:

• No chronic lung disease with hypoxemia

Other:

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

Expected Enrollment

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

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

• Consolidation: Patients achieving complete or partial remission after 4-6 courses of induction therapy begin intensified chemotherapy within 6 weeks. Patients receive oral dexamethasone daily on days 1-10, carmustine IV on day 2, melphalan IV on day 3, etoposide IV daily and cytarabine IV twice a day on days 4-7. Patients also receive filgrastim (G-CSF) beginning on day 11 and continuing until peripheral blood stem cells (PBSC) are harvested.



• Within 4-6 weeks after PBSC harvest, patients undergo myeloablative radiochemotherapy comprising radiotherapy on days -6 to -4 and cyclophosphamide IV on days -3 to -2. Patients then undergo PBSC transplantation on day 0.

Arm II

• Consolidation: Patients receive 2 additional courses of induction chemotherapy as consolidation (for a total of 8 chemotherapy courses).



• Maintenance: Within 4 weeks after arm II consolidation, patients receive interferon alfa subcutaneously (SC) 3 days a week in the absence of unacceptable toxicity or disease progression or relapse. Patients who experience first relapse or progression during maintenance therapy may receive intensified chemotherapy as in arm I.

Patients are followed every 3 months.

Trial Contact Information

Trial Lead Organizations

German Low Grade Lymphoma Study Group

Wolfgang Hiddemann, MD, PhD, Protocol chair		Ph: 49-89-7095-2551

European Organization for Research and Treatment of Cancer

J. C. Kluin-Nelemans, MD, PhD, Protocol chair		Ph: 31-50-361-2354

Gruppo Italiano Studio Linfomi

Alessandro Levis, MD, Protocol chair		Ph: 39-131-206-262 Email: alevis@ospedale.al.it

Groupe d'Etudes de Lymphomes de L'Adulte

Achiel Van Hoof, MD, Protocol chair		Ph: 32-50-45-23-10 Email: achiel.vanhoof@azbrugge.be

Registry Information
Official Title		Treatment of Mantle Cell Lymphomas at Advanced Stages: Prospective Randomized Comparison of Myeloablative Radiochemotherapy Followed by Blood Stem Cell Transplantation Versus Maintenance with Interferon Alpha in First Remission After Initial Cytoreductive Chemotherapy with an Anthracycline Containing Combination
Trial Start Date		2000-12-01
Registered in ClinicalTrials.gov		NCT00016887
Date Submitted to PDQ		2001-04-11
Information Last Verified		2003-08-12

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