acute myeloid leukemia, AML, gemtzuzumab ozogamicin, mylotarg, children, relapse
Conditions
Interventions
Patients will be treated with 2 courses of gemtuzumab ozogamicin with a 14-day interval.
Sponsors
VUmc, Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children with primary refractory or relapsed AML, who do not respond to treatment according to the Relapsed AML 2001/01 re-induction protocol, defined as an M3 marrow after 1 course of chemotherapy or no CR after 2 courses of treatment according to this protocol (either FLAG or FLAG/DNX); 2. Children who relapse after having achieved CR by treatment according to the Relapsed AML 2001/01 trial; 3. Inclusion is NOT dependent on CD33 positivity of the AML cells (i.e. CD33 negative AML�s may also be included); 4. No contra-indication for chemotherapy; 5. Age 50% for patients over 15 years of age, or a Lansky performance status >50% for patients aged 15 years and younger; 7. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; 8. Written informed consent, according to the guidelines of the local institution, is mandatory.
Exclusion criteria
Exclusion criteria: 1. Isolated extramedullary relapse; 2. Active, symptomatic CNS leukemia in case of combined relapse; 3. Hepatic dysfunctioning: i.e. hepatic transaminases elevated more than 3 times above upper normal levels, or hyperbilirubinaemia (>20 �mol/l); 4. Impaired renal function (more than 2 times normal value for creatinine, adjusted for age).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events; 2. All patients will be followed for time to prohression and survival; 3. The number of patients that will undergo stemcell transplantation after re-induction with gemtuzumab. | — |
Contacts
Public ContactC.M. Zwaan
Outcome results
None listed