Outcomes for children with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) are dismal. Therefore, the investigators performed this multicenter, phase II study to evaluate the efficacy and , safety and pharmacokinetic of clofarabine in Chinese pediatric patients with R/R ALL
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Clofarabine (Betta Pharmaceuticals Co., Ltd, Zhejiang, China) was administered intravenously at 52 mg/m2 over 2 hours daily for 5 consecutive days. During the first two induction cycles, patients who did not achieve an objective response were taken off the study, and responsive patients continued to receive consolidation for a maximum 11 cycles if non-hematological toxicity was grade 2 or less.
Department of Pediatrics, Peking University People's Hospital
Beijing, China
Department of Phase 1 Clinical Trial, Peking University People's Hospital
Beijing, China
Guangdong General Hospital, Guangdong Academy of Medical Science
Guangzhou, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, China
overall response rate
Time frame: 8 weeks
patients suffering adverse events
Time frame: 8 weeks
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The First Hospital of China Medical University
Shenyang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China