A phase II study of cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, in patients with very high risk relapsed acute myeloid leukemia.
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| Abstract |
Cloretazine (VNP40101M) is a sulfonylhydrazine alkylating agent with significant anti-leukemia activity. A multicenter phase II study of cloretazine was conducted in patients with first relapse of acute myeloid leukemia (AML) following an initial complete remission (CR) of less than 12 months. Cloretazine was given as a single intravenous infusion at a dose of 600 mg/m(2). Fifty-three patients (median age 62 years (18-84), 41 of 44 (93%) evaluable with intermediate or high risk cytogenetics, 32 (60%) with initial CR durations < or =6 months) were treated on study. Two patients (4%) achieved a second CR. Five (9%) patients died within 30 days of receiving cloretazine therapy. Median overall survival (2.3 months) in the study cohort was directly comparable to that of 233 matched patients treated with other single agents. The study cloretazine regimen had minimal activity in a very high risk subset of patients with relapsed AML.
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| Authors | Francis Giles, Srdan Verstovsek, Stefan Faderl, Norbert Vey, Judy Karp, Gail Roboz, Khuda Dan Khan, Maureen Cooper, Syed Fazl Ali Bilgrami, Augustin Ferrant, Simon Daenen, Verena Karsten, Ann Cahill, Maher Albitar, Hagop Kantarjian, Susan O'Brien, Eric Feldman |
| Journal | Leukemia research (Leuk Res) Vol. 30 Issue 12 Pg. 1591-5 (Dec 2006) ISSN: 0145-2126 [Print] England |
| PMID | 16574225 (Publication Type: Clinical Trial, Phase II, Letter, Multicenter Study) |
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