Phase II Trial Comparing Combination Treatment With Fludarabine and Alemtuzumab to Fludarabine and Rituximab in Patients With B-Cell Chronic Lymphocytic Leukemia Requiring Treatment After First Line Therapy
- Compare the complete response rate in patients with refractory or relapsed B-cell
chronic lymphocytic leukemia treated with fludarabine and alemtuzumab vs fludarabine
- Compare the overall response rate in patients treated with these regimens.
- Compare 1-year survival of patients treated with these regimens.
- Compare time to progression in patients treated with these regimens.
- Compare duration of response in patients treated with these regimens.
- Compare the adverse event profile of these regimens in these patients.
- Compare the molecular response rate in patients treated with these regimens.
- Compare lymphocyte and lymphocyte subset recovery (CD3, CD3/CD4, CD3/CD8, CD20) in
patients treated with these regimens.
- Compare the time to complete response in patients treated with these regimens.
- Compare the rate of cytomegalovirus reactivation and time to reactivation in patients
treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to prior treatment with fludarabine (yes vs no). Patients are randomized to 1 of 2
- Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5. At least 30 minutes
before fludarabine administration, patients receive alemtuzumab subcutaneously (SC) on
- Arm II: Patients receive fludarabine as in arm I. At least 30 minutes before
fludarabine administration, patients receive rituximab IV on days 1 and 4 of course 1
and on day 1 only in subsequent courses.
In both arms, treatment repeats every 28 days for 4-6 courses in the absence of disease
progression or unacceptable toxicity. An interim assessment is performed during course 4.
Patients achieving a partial response or stable disease receive 2 additional courses of
therapy (for a total of 6 courses). Patients achieving a complete response (CR) do not
receive further treatment beyond CR.
Patients are followed weekly for 2 months, monthly for 6 months, every 2 months for 6
months, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Ann S. LaCasce, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15236|
|Cancer Institute of New Jersey at Robert Wood Johnson University Hospital||New Brunswick, New Jersey 08903|
|Western Pennsylvania Cancer Institute||Pittsburgh, Pennsylvania 15224|
|Jackson Oncology Associates, PLLC||Jackson, Mississippi 39202|