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

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

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clofarabine

Drug

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 outcomes

overall response rate

Time frame: 8 weeks

Secondary outcomes

patients suffering adverse events

Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Betta Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

Phase II, Multi-center, and Pharmacokinetic Study of Efficacy, Safety and Pharmacokinetic of Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: Sep 9, 2015
Registry last updated: Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed