A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome
- Determine the maximum tolerated dose (MTD) of VNP40101M in patients with Richter
syndrome or refractory or relapsed chronic lymphocytic leukemia or other
lymphoproliferative disease. (phase I)
- Determine the toxic effects of this drug in these patients. (phase I)
- Determine the efficacy, as determined by overall response rate, of this drug at the MTD
determined in phase I in these patients. (phase II)
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
- Phase I: Patients receive VNP40101M IV over 30 minutes on day 1. Courses repeat every
3-6 weeks for up to 6 courses in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
- Phase II: Patients receive VNP40101M at the MTD determined in phase I.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Primary Purpose: Treatment
Maximum tolerated dose
Bonny L. Johnson, RN, MSN
United States: Federal Government
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