Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma

May 13, 2019 updated by: Swiss Group for Clinical Cancer Research

A Randomized, Phase III Trial to Determine the Effect of Consolidation With Rituximab (IDEC C2B8-Mabthera) in Patients With CD20+ Follicular or Mantle Cell Lymphoma Having Received Induction Therapy With Rituximab Weekly x 4

RATIONALE: 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 which treatment regimen is more effective for lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of rituximab in treating patients who have follicular or mantle cell lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Assess the clinical efficacy of consolidation treatment with rituximab in terms of response rate in patients with follicular (closed to accrual 9/18/00) or mantle cell lymphoma.
  • Compare the event free survival of patients after induction with or without consolidation.
  • Compare the tolerability of these two treatment regimens by these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to participating center, histology (follicular (closed to accrual 9/18/00) vs mantle cell), status of disease (de novo vs relapsed vs resistant), response after induction (stable disease vs partial or complete response), and treatment status (treated vs untreated).

All patients receive induction therapy consisting of rituximab IV over 3-5 hours once a week during weeks 1-4. Patients are then randomized to one of two treatment arms.

  • Arm I: Patients are observed.
  • Arm II: Patients receive rituximab IV over 3-5 hours once a week during weeks 12, 20, 28, and 36.

Patients are followed weekly for the first month; every 8 weeks for the next 8 months; then at 12, 18, and 24 months; and then annually for the next 3 years.

PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 3-4 years.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonspital Aarau
      • Basel, Switzerland, CH-4031
        • University Hospital
      • Basel, Switzerland, CH 4051
        • Office of Walter Weber-Stadelman
      • Bellinzona, Switzerland, CH-6500
        • Ospedale San Giovanni
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Geneva, Switzerland, CH-1211
        • Hopital Cantonal Universitaire de Geneva
      • Lugano, Switzerland, CH-6900
        • Istituto Oncologico della Svizzera Italiana
      • Solothurn, Switzerland, 4500
        • Burgerspital, Solothurn
      • Zurich, Switzerland, 8063
        • City Hospital Triemli
      • Zurich, Switzerland, CH-8008
        • Klinik Hirslanden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically proven CD20 positive follicular (closed to accrual 9/18/00) or mantle cell lymphoma

    • Untreated "de novo" disease OR
    • Chemotherapy resistant disease OR
    • Relapsing disease
  • Bidimensionally measurable disease
  • No symptomatic CNS disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • No hepatitis B or C

Renal:

  • Creatinine no greater than 2 times ULN

Cardiovascular:

  • Ejection fraction at least 50%

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active opportunistic infections
  • HIV negative
  • No prior malignancy within 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior antibody based therapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas) and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior corticosteroids, unless chronic dose no greater than 20 mg/day for nonlymphoma related condition
  • No other concurrent corticosteroids

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Study Chair: Michele Ghielmini, MD, Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Primary Completion (Actual)

March 1, 2002

Study Completion (Actual)

March 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 23, 2003

First Posted (Estimate)

September 24, 2003

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 35/98
  • SWS-SAKK-35/98
  • ICR-35/98
  • EU-98009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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