Phase II Study of Pentostatin With Cyclophosphamide and Rituximab for Previously Untreated Patients With Chronic Lymphocytic Leukemia
OBJECTIVES:
- To determine the frequency of response in patients with previously untreated,
intermediate- or high-risk B-cell chronic lymphocytic leukemia (CLL) treated with
pentostatin, cyclophosphamide, and rituximab.
- To characterize the toxicity of this regimen in these patients.
OUTLINE: Patients receive cyclophosphamide IV followed by pentostatin IV on day 1 in course
1. Beginning in course 2 and in all subsequent courses, patients receive cyclophosphamide IV
on day 1, pentostatin IV on day 1, and rituximab IV on day 1 or on days 1 and 2. Treatment
repeats every 3 weeks for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed at least every 3 months for 1
year.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response
2 years
No
Nicole Lamanna, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
05-051
NCT00541034
May 2005
May 2014
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |