Clinical trial · Interventional
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
NCT02544789CI-TRIAL-00019086completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- clofarabine
- 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.
- interventionNames
- Drug: Clofarabine
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- 8 weeks
Secondary outcomes (1)
- measure
- patients suffering adverse events
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.