CFAR Study in Patients With Chronic Lymphocytic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00525603
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    200 mg/m\^2/day 3-5 IV 5-30 minutes
  • Fludarabine — DRUG
    20 mg/m\^2/day 3-5 IV 5-30 minutes
  • Alemtuzumab — DRUG
    30 mg Days 1, 3, 5 IV 2-4 hours
  • Rituximab — DRUG
    375 mg/m\^2/day 2 IV 4-6 hours

Study Details

Primary Objective: 1\. Evaluate the ability of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) to increase the proportion of patients with \<5% CD5/CD19+ cells in bone marrow to 66% following 3 courses of treatment without significantly increasing the incidence of pneumonia or sepsis compared to a historic group of patients treated with the combination fludarabine, cyclophosphamide, and rituximab (FCR). Second Objectives: 1. Assess complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. 2. Evaluate molecular remission in bone marrow by polymerase chain reaction (PCR) for the clonal immunoglobulin heavy chain variable gene in responders treated with CFAR. 3. Assess immune parameters including blood T cell counts and subset distribution and serum immunoglobulin levels pretreatment, during treatment, and post-treatment in patients treated with CFAR.

Key Dates

Start date
Jun 30, 2005
Status verified
Jan 2013
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

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

Arms

  • Experimental: CFAR
    CFAR = Cyclophosphamide 200 mg/m\^2/day 3-5 intravenous (IV) 5-30 minutes, Fludarabine 20 mg/m\^2/day 3-5 IV 5-30 minutes, Alemtuzumab 30 mg 1, 3,5 IV 2-4 hours, and Rituximab 375 mg/m\^2/day 2 IV 4-6 hours

Primary Outcome Measure

Overall Participant Response [ Time Frame: Evaluated after 3 courses of 4 week therapy (12 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
The University of Texas M.D. Anderson Cancer Center· Houston, TX

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