No registrations found.
ID
Source
Brief title
Health condition
acute myeloid leukemia, AML, gemtzuzumab ozogamicin, mylotarg, children, relapse
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall response rate.
Secondary outcome
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.
Background summary
Summary:
Children with relapsed/refractory AML have a dire prognosis and new treatment options are urgently needed. Gemtuzumab ozogamicin is an immunoconjugate, consisting of a humanized anti-CD33 antibody, linked to calicheamicin, a cytotoxic anti-tumor antibiotic. By this approach the chemotherapy is delivered more selectively to the leukemic cells, which may increase anti-leukemic effectiveness and cause less side effects. In studies in adults response rates of approximately 30% have been reported. In a pediatric phase I study the recommended phase II dose was 7.5 mg/m2 given twice with a 14-day interval.
We therefore designed an open-label phase II study with gemtuzumab ozogamicin, given as single agent at a dose of 7.5 mg/m2 IV, twice with a 14-day interval, in children with refractory AML after 1st relapse and re-induction according to the Relapsed AML 2001/01 study, or children with a second relapse of AML. The main objective is to assess the complete response rate after treatment with gemtuzumab ozogamicin as a single agent. The secondary objective is to determine the safety profile of re-induction with gemtuzumab ozogamicin. When a complete response is achieved after 2 courses patients may proceed to stem-cell transplantation, and the number of patients that are eligible for a stem cell transplant is a secondary objective.
Study objective
To assess whether children with relapsed/refractory AML, who do not achieve remission or relapse after treatment with the Relapsed AML 2001/01 standard reinduction protocol (fludarabine, cytarabine and GCSF with or without DaunoXome�), can be salvaged by treatment with Mylotarg� (gemtuzumab ozogamicin) as a single agent. The principal endpoint is overall complete response.
Study design
Patients will be evaluated after 2 courses of treatment.
Intervention
Patients will be treated with 2 courses of gemtuzumab ozogamicin with a 14-day interval.
Erasmus MC
Dr Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
research-kocr@erasmusmc.nl
Erasmus MC
Dr Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
research-kocr@erasmusmc.nl
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 <19 years;
6. A Karnofsky performance status >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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1600 |
| NTR-old | NTR1680 |
| Other | Relapsed AML I-BFM study/METC ErasmusMC : 2001/02/ 01/215 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |