A Phase I-II Study of Pentostatin With Cyclophosphamide for Previously Treated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia
- Determine the dose of cyclophosphamide, with filgrastim (G-CSF) support, that can be
safely administered with pentostatin and rituximab in patients with previously treated
intermediate- or high-risk chronic lymphocytic leukemia or other low-grade B-cell
malignancies. (Phase I closed to accrual effective 11/27/2001.)
- Characterize the toxicity of this regimen in these patients.
- Determine the incidence of response in these patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of cyclophosphamide (CTX).
- Phase I: Patients receive CTX IV followed by pentostatin IV on day 1 of course 1.
Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 3
and continuing until blood counts recover. During the second and subsequent courses,
patients receive CTX IV, pentostatin IV, and rituximab IV on day 1. Patients also
receive G-CSF as in course 1. Treatment repeats every 3 weeks for 3 courses in the
absence of disease progression or unacceptable toxicity. Patients with at least a
partial response after the third course receive an additional 3 courses.
Cohorts of 3-6 patients receive escalating doses of CTX until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6
patients experience dose-limiting toxicity.
(Phase I closed to accrual effective 11/27/2001.)
- Phase II: Patients receive CTX at the recommended phase II dose and treatment as above.
Patients are followed at least every 3 months for 1 year and then periodically thereafter.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I portion of this
study. (Phase I closed to accrual effective 11/27/2001.) A total of 14-30 patients will be
accrued for the phase II portion of this study within 2.5 years.
Primary Purpose: Treatment
Mark Adam Weiss, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
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