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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.
• Treatments: Clofarabine

Criteria

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