一项针对新型磺酰肼类烷基化剂氯雷他嗪（VNP40101M）治疗极高风险复发急性髓系白血病患者的II期研究。

A phase II study of cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, in patients with very high risk relapsed acute myeloid leukemia.

作者信息

Giles Francis, Verstovsek Srdan, Faderl Stefan, Vey Norbert, Karp Judy, Roboz Gail, Khan Khuda Dan, Cooper Maureen, Bilgrami Syed Fazl Ali, Ferrant Augustin, Daenen Simon, Karsten Verena, Cahill Ann, Albitar Maher, Kantarjian Hagop, O'Brien Susan, Feldman Eric

出版信息

Leuk Res. 2006 Dec;30(12):1591-5. doi: 10.1016/j.leukres.2006.02.019. Epub 2006 Mar 29.

DOI:10.1016/j.leukres.2006.02.019

PMID:16574225

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.

摘要

氯雷他嗪（VNP40101M）是一种具有显著抗白血病活性的磺酰肼类烷化剂。一项关于氯雷他嗪的多中心II期研究在初次完全缓解（CR）持续时间少于12个月后首次复发的急性髓系白血病（AML）患者中进行。氯雷他嗪以600mg/m²的剂量单次静脉输注给药。53例患者（中位年龄62岁（18 - 84岁），44例中有41例（93%）可评估，具有中高危细胞遗传学特征，32例（60%）初始CR持续时间≤6个月）接受了该研究治疗。2例患者（4%）实现了第二次CR。5例（9%）患者在接受氯雷他嗪治疗后30天内死亡。研究队列中的中位总生存期（2.3个月）与233例接受其他单药治疗的匹配患者的总生存期直接可比。该研究的氯雷他嗪治疗方案在复发AML的极高危亚组患者中活性极小。