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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02544789

Enrollment

Registered

2015-09-09

Start date

2009-06-30

Completion date

2012-05-31

Last updated

2015-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

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

Interventions

DRUGClofarabine

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 21 Years

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

Design outcomes

Primary

Measure	Time frame
overall response rate	8 weeks

Secondary

Measure	Time frame
patients suffering adverse events	8 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026