FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00381004
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    Course 1: 250 mg/m\^2 by vein over 5-30 minutes on Days 2, 3, and 4; Course 2 - 6: 250 mg/m\^2 by vein over 5-30 minutes on Days 1 - 3
  • Fludarabine — DRUG
    Course 1: 25 mg/m\^2 by vein over 5-30 minutes on Days 2,3, and 4; Course 2 - 6: 25 mg/m\^2 by vein over 5-30 minutes on Days 1 - 3
  • Sargramostim — DRUG
    Course 1: 250 mcg/m\^2 subcutaneous (SQ) on Days -1 and Days 5 - 11; Course 2 - 6: 250 mcg/m\^2 SQ on Days -1 and Days 4 - 10
  • Rituximab — DRUG
    Course 1: 375 mg/m\^2 by vein over 2-6 Hours on Day 1; Course 2 - 6: 500 mg/m\^2 by vein over 2-6 Hours on Day 1

Study Details

The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and rituximab, with sargramostim (GM-CSF) can help to control previously untreated chronic lymphocytic leukemia (CLL). The safety of this combination will also be studied. This study will evaluate antibody-dependent cellular cytotoxicity (ADCC) and its relationship to response.

Key Dates

Start date
Sep 30, 2006
Status verified
Dec 2015
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Experimental: FCR + Sargramostim
    Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m\^2 IV Days 2-4; Course 2-6: 25 mg/m\^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m\^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m\^2 Days 1-3. Rituximab - Course 1: 375 mg/m\^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m\^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m\^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m\^2 SQ Days -1 and 4-10.

Primary Outcome Measure

Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. [ Time Frame: Baseline to 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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