Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma

Sponsor
Institute of Cancer Research, United Kingdom
Study ID
NCT00053092
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • fludarabine phosphate — DRUG

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. 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 if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma. PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma.

Key Dates

Start date
Oct 31, 2002
Status verified
Jun 2007
Completion
Feb 28, 2009

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Response rate

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