Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00794820
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Fludarabine Phosphate — DRUG
    25 mg/m\^2 by vein over 5-30 minutes daily for 3 days (days 2-4)
  • Cyclophosphamide — DRUG
    250 mg/m\^2 by vein over 60 minutes daily for 3 days (days 2-4)
  • Rituximab — DRUG
    375 mg/m\^2 by vein for dose 1 (given 1 day prior to chemotherapy) and then 500 mg/m\^2 on days 2-3

Study Details

Primary Objective: * To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL. Secondary Objective: * To evaluate remission duration and survival.

Key Dates

Start date
Dec 31, 2003
Status verified
Apr 2018
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Experimental: FCR-Multiple Dose Rituximab
    Fludarabine phosphate + Cyclophosphamide + Rituximab

Primary Outcome Measure

Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

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

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