Back to resultsClofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia
Primary Purpose
Acute Lymphoblastic Leukemia
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Clofarabine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia
Eligibility Criteria
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
Sites / Locations
- Department of Pediatrics, Peking University People's Hospital
- Department of Phase 1 Clinical Trial, Peking University People's Hospital
- Guangdong General Hospital, Guangdong Academy of Medical Science
- The First Affiliated Hospital, Zhejiang University
- The First Hospital of China Medical University
- The First Affiliated Hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
clofarabine
Arm 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.
Outcomes
Primary Outcome Measures
overall response rate
Secondary Outcome Measures
patients suffering adverse events
Full Information
NCT ID
NCT02544789
First Posted
September 5, 2015
Last Updated
September 8, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02544789
Brief Title
Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clofarabine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Clofarabine
Intervention 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.
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
patients suffering adverse events
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Lu, MD
Organizational Affiliation
Department of Pediatrics, Peking University People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pediatrics, Peking University People's Hospital
City
Beijing
Country
China
Facility Name
Department of Phase 1 Clinical Trial, Peking University People's Hospital
City
Beijing
Country
China
Facility Name
Guangdong General Hospital, Guangdong Academy of Medical Science
City
Guangzhou
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia
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