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

This study is no longer recruiting patients.

Sponsored by: Swiss Institute for Applied Cancer Research
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
noncontiguous stage II mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
contiguous stage II mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
 Procedure: biological response modifier therapy
 Procedure: monoclonal antibody therapy
 Procedure: antibody therapy
 Drug: rituximab
Phase III

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Rituximab Consolidation Following Rituximab Induction in Patients With CD20 Positive Follicular or Mantle Cell Lymphoma

Further Study Details: 

Study start: January 1998

OBJECTIVES: I. 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. II. Compare the event free survival of patients after induction with or without consolidation. III. Compare the tolerability of these two treatment regimens by these patients.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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 nonmelanomatous skin cancer

Location Information


Switzerland
      Burgerspital, Solothurn, Solothurn,  4500,  Switzerland

      City Hospital Triemli, Zurich,  8063,  Switzerland

      Hopital Cantonal Universitaire de Geneva, Geneva,  CH-1211,  Switzerland

      Inselspital, Bern, Bern,  CH-3010,  Switzerland

      Istituto Oncologico della Svizzera Italiana, Lugano,  CH-6900,  Switzerland

      Kantonspital Aarau, AARAU,  5001,  Switzerland

      Klinik Hirslanden, Zurich,  CH-8008,  Switzerland

      Office of Walter Weber-Stadelman, Basel,  CH 4051,  Switzerland

      Ospedale San Giovanni, Bellinzona,  CH-6500,  Switzerland

      University Hospital, Basel,  CH-4031,  Switzerland

Study chairs or principal investigators

Michele Ghielmini,  Study Chair,  Swiss Institute for Applied Cancer Research   

More Information

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

Study ID Numbers:  CDR0000066188; SWS-SAKK-35/98; EU-98009; ICR-35/98
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003280
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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