Phase I/II Study Of UCN-01 In Combination With Fludarabine In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma
- Determine the overall response rate in patients with relapsed or refractory chronic
lymphocytic leukemia (CLL) or small lymphocytic lymphoma treated with UCN-01 and
- Assess the molecular changes in CLL cells in peripheral blood in patients treated with
- Determine the progression-free and overall survival of patients treated with this
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of UCN-01.
Patients receive UCN-01 IV over 3 hours on day 1 and fludarabine IV over 30-60 minutes on
days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 18-46
additional patients receive UCN-01 and fludarabine as above at the recommended phase II
PROJECTED ACCRUAL: A total of 12 patients will be accrued for the phase I portion of this
study within 6 months. A total of 18-46 patients will be accrued for the phase II portion of
this study within 9-23 months.
Primary Purpose: Treatment
Michael R. Crump, MD, FRCPC
Princess Margaret Hospital, Canada
United States: Federal Government