Phase II clinical study of cladribine in the treatment of hairy cell leukemia.
We conducted a phase II clinical study to evaluate the therapeutic efficacy of cladribine (2-chlorodeoxyadenosine [2-CdA]) in the treatment of Japanese patients with hairy cell leukemia (HCL). Seven patients with classic HCL and 3 with a prolymphocytic HCL variant were administered 2-CdA (0.09 mg/kg per day) by continuous intravenous infusion for 7 days. Seven patients responded to this therapy, with 5 patients achieving a complete response (CR). After a median follow-up of 792 days (range, 599-1253 days), there were no cases of clinical relapse, and the median duration of the response in the responders was 670+ days (range, 470+ to 1121+ days). The median duration of the CR in the CR patients was 953+ days (range, 480+ to 1121+ days). At treatment initiation, most patients had hematologic impairment as a manifestation of HCL. During the early stage after administration, further hematologic impairment occurred, but subsequent peripheral blood counts gradually recovered as 2-CdA treatment showed antitumor activity. Infections occurred at a high incidence at this time, but all cases could be controlled with appropriate treatment. 2-CdA was surmised to represent a useful therapeutic approach for Japanese patients with HCL.
Machii
Takashi
T
Department of Hematology and Oncology, Osaka University Graduate School of Medicine, Osaka, Japan. ta-mach@pop.cypress.ne.jp
Chou
Takaaki
T
Suzuki
Muneou
M
Ohe
Yokiko
Y
Katagiri
Shuichi
S
Kitano
E Kiyoshi
EK
Kitano
Kiyoshi
K
Fujiyama
Yoshihide
Y
Izumi
Tooru
T
Shimazaki
Chihiro
C
Nanba
Koji
K
Ohashi
Yasuo
Y
Kitani
Teruo
T
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D017338:Cladribine / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007943:Leukemia, Hairy Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D017338:Cladribine