Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

November 30, 2011

Study Completion Date

May 31, 2012

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

Clofarabine

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.

Trial Locations (6)

Unknown

Department of Pediatrics, Peking University People's Hospital, Beijing

Department of Phase 1 Clinical Trial, Peking University People's Hospital, Beijing

Guangdong General Hospital, Guangdong Academy of Medical Science, Guangzhou

The First Affiliated Hospital, Zhejiang University, Hangzhou

The First Hospital of China Medical University, Shenyang

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

All Listed Sponsors
lead

Betta Pharmaceuticals Co., Ltd.

INDUSTRY