Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00098670
Phase
PHASE2
Status
Completed

Conditions

  • B-cell Chronic Lymphocytic Leukemia
  • Stage I Chronic Lymphocytic Leukemia
  • Stage II Chronic Lymphocytic Leukemia
  • Stage III Chronic Lymphocytic Leukemia
  • Stage IV Chronic Lymphocytic Leukemia

Eligibility Criteria

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

Interventions

  • alemtuzumab — BIOLOGICAL
    Given SC
  • rituximab — BIOLOGICAL
    Given IV
  • fludarabine phosphate — DRUG
    Given IV

Study Details

This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others can find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fludarabine together with rituximab followed by alemtuzumab may kill more cancer cells.

Key Dates

Start date
Oct 31, 2004
Status verified
Dec 2012
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

Enrollment
102 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (alemtuzumab, rituximab, fludarabine phosphate)
    Patients receive induction therapy comprising rituximab IV over 4 hours on days 1, 3, and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression. Approximately 4 months after completion of induction therapy, patients achieving a partial response, nodular partial response, or stable disease receive consolidation therapy comprising alemtuzumab subcutaneously on days 1-3. Treatment repeats weekly for up to 6 courses in the absence of disease progression.

Primary Outcome Measure

Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab [ Time Frame: Duration of treatment (up to 13.5 months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Cancer and Leukemia Group BChicagoIllinois60606-
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbusOhio43210-

Find similar trials in Chicago, IL

By research site
Cancer and Leukemia Group B· Chicago, ILArthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center· Columbus, OH

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