A phase II study of clofarabine in combination with cytarabine and daunoxome for children with acute myeloid leukemia withour other treatment options.
Completed
- Conditions
- acute myeloid leukemia in childrenrelapserefactory
- Registration Number
- NL-OMON22399
- Lead Sponsor
- Erasmus MC, Rotterdam, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
1. 2nd relapse of AML;
2. Refractory AML in 1st relapse (defined as ≥ 20% blasts in the bone marrow after the 1st course of re-induction therapy according to the AML 2001/01 protocol);
Exclusion Criteria
1. Isolated extramedullary relapse, including isolated CNS-relapse;
2. Symptomatic CNS leukemia in case of combined relapse;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish the recommended dose of clofarabine in combination with cytarabine and liposomal daunorubicin (DaunoXome®) in children with relapsed/refractory AML, based on the FLAG regimen as used in the Relapsed AML 2001/01 study.
- Secondary Outcome Measures
Name Time Method 1. To determine the safety and tolerability of this combination;<br /><br>2. To determine (preliminary) efficacy in terms of the hematological remission rate in these patients;<br /><br>3. To describe the durability of response, including the number of patients that undergo stem-cell transplant after re-induction with this regimen;<br /><br>4. To describe the pharmacokinetics of clofarabine in combination with cytarabine and liposomal daunorubicin;<br /><br>5. To preliminary assess the CSF blast disappearance, and the CSF-levels of clofarabine.<br>