`A Phase II Study of Alternating Cycles of Fludarabine and Cyclophosphamide in Previously Untreated Patients With B-Cell CLL
OBJECTIVES: I. Determine the rate and duration of complete and partial remissions in
patients with previously untreated B-cell chronic lymphocytic leukemia after treatment with
alternating courses of fludarabine and cyclophosphamide. II. Monitor and assess toxicity of
this regimen in these patients. III. Utilize molecular genetic studies and flow cytometry on
peripheral blood cells from patients achieving complete remission by conventional criteria.
IV. Apply FISH techniques using probes to chromosomes 12 and 13 as prognostic factors for
time to progression and overall survival of these patients.
OUTLINE: Patients receive alternating courses of fludarabine and cyclophosphamide.
Fludarabine is administered IV over 10-30 minutes on days 1-5 of courses 1, 3, and 5.
Cyclophosphamide is administered IV over 30-60 minutes on day 1 of courses 2, 4, and 6.
Treatment repeats every 4 weeks. Patients achieving clinical complete remission (CCR) after
6 courses of chemotherapy receive 2 additional courses (one course of each drug). Patients
achieving partial remission after 6 courses of chemotherapy also receive 2 additional
courses. If these patients then achieve CCR, they receive another 2 courses. Patients are
followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 22 months.
Primary Purpose: Treatment
Thomas E. Witzig, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Ann Arbor Regional||Ann Arbor, Michigan 48106|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Duluth||Duluth, Minnesota 55805|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CentraCare Clinic||Saint Cloud, Minnesota 56303|
|Quain & Ramstad Clinic, P.C.||Bismarck, North Dakota 58501|
|Altru Health Systems||Grand Forks, North Dakota 58201|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|