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

NCT02544789 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2015-09-09

No results posted yet for this study

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

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin Lu, MD · Department of Pediatrics, Peking University People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-11-30
Completion
2012-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544789 on ClinicalTrials.gov