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

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544789
• Other study ID #: BD-3-C01
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2015
• Last updated: September 8, 2015
• Start date: June 2009
• Est. completion date: May 2012

Study information

• Verified date: September 2015
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 21 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		8 weeks	No
Secondary	patients suffering adverse events		8 weeks	Yes