A phase II study of cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, in patients with very high risk relapsed acute myeloid leukemia.
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.
Giles
Francis
F
Verstovsek
Srdan
S
Faderl
Stefan
S
Vey
Norbert
N
Karp
Judy
J
Roboz
Gail
G
Khan
Khuda Dan
KD
Cooper
Maureen
M
Bilgrami
Syed Fazl Ali
SF
Ferrant
Augustin
A
Daenen
Simon
S
Karsten
Verena
V
Cahill
Ann
A
Albitar
Maher
M
Kantarjian
Hagop
H
O'Brien
Susan
S
Feldman
Eric
E
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D005260:Female; D006801:Humans; D006834:Hydrazines / Q000008:administration & dosage* / Q000009:adverse effects; D007262:Infusions, Intravenous; D007951:Leukemia, Myeloid / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D012307:Risk Factors; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D015996:Survival Rate; D016896:Treatment Outcome
D006834:Hydrazines; D013449:Sulfonamides; C483604:laromustine