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

Betta Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Clofarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02544789

BD-3-C01

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

clofarabine

Experimental group

Description:

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.

Treatment:

Drug: Clofarabine