Refractory or relapsed acute myeloid leukemia in children and adolescents.
Conditions
Interventions
Addition of liposomal daunorubicin (DaunoXome®) to FLAG in reinduction course I.
Sponsors
Dutch Childhood Oncology Group
Den Haag
The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Primary refractory AML; 2. First relapsed AML; 3. 2nd or subsequent relapsed AML, but not previously treated according to protocol Relapsed AML 2001/01; 4. <18 years of age at initial diagnosis; 5. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Symptomatic cardiac dysfunction (CTC grade 3 or 4), and/or a fractional shortening at echocardiography below 29%; 2. Karnofsky performance status <40% (children aged 16 years and older) or Lansky performance status of <40% (yougner children); 3. Any other organ dysfunction (CTC grade 4) that will interfere with the protocol treatment; 4. Inability to apply to the protocol for other reasons; 5. AML FAB type M3, acute promyelocytic leukemia, and/or t(15;17) and/or PML-RARalfa fusion gene.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of BM blasts >20% after course I, determined 4-6 weeks after the start. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity, focussing on but not limited to bone marrow aplasia, mucosal toxicity and cardiotoxicity; 2. Efficacy as determined by day 14 BM blasts, time to PB clearance of blasts, CR rate after 2 course of chemotherapy, % of patients that underwent SCT, overall survival, event-free survival and disease-free survival; 3. Clinical and cell biological features, and overall outcome of the entire cohort of patients with relapsed AML that has been registered in the time period of patient accrual (also including patients that were not treated according to this protocol). | — |
Contacts
Public ContactGertjan J.L. Kaspers
VU University Medical Center, Department of Pediatric Oncology/Hematology, De Boelelaan 1117
Outcome results
None listed