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
1 other identifier
interventional
44
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2009
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 5, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedSeptember 9, 2015
September 1, 2015
2.4 years
September 5, 2015
September 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
overall response rate
8 weeks
Secondary Outcomes (1)
patients suffering adverse events
8 weeks
Study Arms (1)
clofarabine
EXPERIMENTALClofarabine (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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Department of Pediatrics, Peking University People's Hospital
Beijing, China
Department of Phase 1 Clinical Trial, Peking University People's Hospital
Beijing, China
Guangdong General Hospital, Guangdong Academy of Medical Science
Guangzhou, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, China
The First Hospital of China Medical University
Shenyang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jin Lu, MD
Department of Pediatrics, Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2015
First Posted
September 9, 2015
Study Start
June 1, 2009
Primary Completion
November 1, 2011
Study Completion
May 1, 2012
Last Updated
September 9, 2015
Record last verified: 2015-09