Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia

Sponsor
Cancer Research UK
Study ID
NCT00337246
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with rituximab may kill more cancer cells. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia.

Key Dates

Start date
Jul 31, 2005
Status verified
May 2007
Completion
Mar 31, 2011

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Overall response rate as measured by NCI Response Criteria

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