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

Phase 2

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Clofarabine

• Registration Number: NCT02544789
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2011-11
• Study Completion: 2012-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-05
• Study First Submitted QC: 2015-09-08
• Last Update Submitted: 2015-09-08
• Study First Posted: 2015-09-09
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Pediatric patients (younger than 21 years old) with acute lymphoblastic leukemia confirmed by histology
• Refractory or relapsed acute lymphocytic leukemia who had received at least two drugs treatment
• No prior chemotherapy within 2 weeks before entry and resolution of toxic effects from prior therapy
• Normal cardiac function, adequate hepatic function [total bilirubin ≤1.5× upper limit of normal (ULN), aspartate aminotransferase (AST) alanine aminotransferase (ALT) ≤ 3ULN] and renal function (serum creatinine ≤ 2 ULN)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy more than 3 months

Exclusion Criteria

• AEs not recovered from prior therapy
• Within 3 months from allogeneic or autologous stem cell transplantation
• With central nervous involvement or uncontrolled infection
• Patients who used clofarabine before or allergic to fludarabine or cladribine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
clofarabine	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.

Primary Outcome Measures

Name	Time	Method
overall response rate	8 weeks

Secondary Outcome Measures

Name	Time	Method
patients suffering adverse events	8 weeks

Trial Locations

Locations (6)

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, China

Department of Pediatrics, Peking University People's Hospital; 🇨🇳 Beijing, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, China

Guangdong General Hospital, Guangdong Academy of Medical Science; 🇨🇳 Guangzhou, China

The First Affiliated Hospital, Zhejiang University; 🇨🇳 Hangzhou, China

Department of Phase 1 Clinical Trial, Peking University People's Hospital; 🇨🇳 Beijing, China