FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 14, 2005

Primary Completion Date

September 14, 2017

Study Completion Date

September 14, 2017

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Fludarabine

Fludarabine 25 mg/m2 on Days 2,3,4 i.v. 5-30 mins for course 1, and on Days 1 - 3 for courses 2 - 6

DRUG

Cyclophosphamide

Cyclophosphamide 250 mg/m2 on Day 2,3,4 i.v. 5-30 mins for course 1, and on Days1 - 3 for courses 2 - 6.

DRUG

Mitoxantrone

Mitoxantrone 6 mg/m2 on Day 2 i.v. 30-60 mins for course 1, and on Day 1 for courses 2 - 6.

DRUG

Rituximab

Rituximab 375 mg/m2 on Day 1 i.v. 2-6 hours for course 1 and 500 mg/m2 on Day 1 for courses 2 - 6.

DRUG

Filgrastim

Pegylated Filgrastim - 6 mg on Day 4,s.c. for course 1 and on Day 3 for courses 2 - 6.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
collaborator

OSI Pharmaceuticals

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER