Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia
NCT ID: NCT02544789
Last Updated: 2015-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2009-06-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
21 Years
ALL
No
Sponsors
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Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jin Lu, MD
Role: STUDY_CHAIR
Department of Pediatrics, Peking University People's Hospital
Locations
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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
Countries
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Other Identifiers
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BD-3-C01
Identifier Type: -
Identifier Source: org_study_id
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