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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00003280
First received: November 1, 1999
Last updated: May 14, 2012
Last verified: May 2012

November 1, 1999
May 14, 2012
January 1998
March 2002   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003280 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma
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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Biological: rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
March 2002
March 2002   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00003280
SAKK 35/98, SWS-SAKK-35/98, ICR-35/98, EU-98009
Not Provided
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
Not Provided
Study Chair: Michele Ghielmini, MD Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Swiss Group for Clinical Cancer Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP