A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas
- Determine the maximum tolerated dose of clofarabine in patients with relapsed or
refractory T-cell or natural killer-cell lymphoma.
- Determine the toxicity of this drug in these patients.
- Determine, preliminarily, the efficacy of this drug, in terms of response rate, in
OUTLINE: This is a phase I, non-randomized, dose-escalation study followed by an open-label,
phase II study.
- Phase I: Patients receive clofarabine IV over 1 hour once daily on days 1-3. Treatment
repeats every 21 days for up to 2 courses in the absence of disease progression or
unacceptable toxicity. Patients achieving stable disease or partial response (PR) or
complete response (CR) may receive 2 additional courses of treatment. Patients with PR
or CR after completing 4 courses of therapy may receive 2 additional courses.
Cohorts of 1-6 patients receive escalating doses of clofarabine 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 II: Patients receive clofarabine as in phase I at the MTD determined in phase I.
After completion of study treatment, patients are followed every 3 months for 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (Phase I)
Steven M. Horwitz, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|