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Status unknownNCT00016887Updated Sep 17, 2013

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

A Phase 3 interventional study of filgrastim and recombinant interferon alfa in Lymphoma, sponsored by German Low Grade Lymphoma Study Group. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-09-17.

Sponsored by German Low Grade Lymphoma Study Group · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2003), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.
  • Compare the overall survival of patients treated with early vs late myeloablative radiochemotherapy and PBSCT.
  • Compare disease-free survival and overall survival of patients treated with this regimen vs historic controls of similar cases.

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.

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

02

Conditions studied

  • Lymphoma

Keywords

  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
03

In context

Lymphoma

5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.

Browse Lymphoma studies →

Lead sponsor

German Low Grade Lymphoma Study Group is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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:

  • No chronic lung disease with hypoxemia

Other:

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized

Interventions

06

Study locations

2 sites
  • AZ Sint-Jan
    Bruges, 8000, Belgium
  • Ospedale Civile Alessandria
    Alessandria, I-15100, Italy
07

References and documents

Publications

  • Determann O, Hoster E, Ott G, Wolfram Bernd H, Loddenkemper C, Leo Hansmann M, Barth TE, Unterhalt M, Hiddemann W, Dreyling M, Klapper W; European Mantle Cell Lymphoma Network and the German Low Grade Lymphoma Study Group. Ki-67 predicts outcome in advanced-stage mantle cell lymphoma patients treated with anti-CD20 immunochemotherapy: results from randomized trials of the European MCL Network and the German Low Grade Lymphoma Study Group. Blood. 2008 Feb 15;111(4):2385-7. doi: 10.1182/blood-2007-10-117010. Epub 2007 Dec 12. PubMed 18077791 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00016887
Lead sponsor
German Low Grade Lymphoma Study Group
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC, Gruppo Italiano Studio Linfomi, Lymphoma Study Association
First posted
Jan 27, 2003
Start date
Dec 2000
Last update
Sep 17, 2013

Study contacts

Wolfgang Hiddemann, MD, PhD
study chair · Klinikum der Universitaet Muenchen - Grosshadern Campus
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
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2003. You cannot join it, but the record below documents what was studied.

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