NCT00381004 - FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions

Chronic Lymphocytic Leukemia

Interventions

DRUG

Cyclophosphamide

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

DRUG

Fludarabine

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

DRUG

Sargramostim

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

DRUG

Rituximab

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

Trial Locations (1)

University of Texas MD Anderson Cancer Center, Houston