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Mylotarg as salvage treatment for children with relapsed acute myeloid leukemia.


- candidate number5353
- NTR NumberNTR1680
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-feb-2009
- Secondary IDs2001/02/ 01/215 Relapsed AML I-BFM study/METC ErasmusMC
- Public TitleMylotarg as salvage treatment for children with relapsed acute myeloid leukemia.
- Scientific TitleEfficacy and safety of Mylotarg� (gemtuzumab ozogamicin) as salvage treatment in children with refractory or relapsed acute myeloid leukemia.
- ACRONYMRelapsed AML 2001/02
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML), Children, Relapse
- Inclusion criteria1. 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 criteria1. 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).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 20-mrt-2002
- planned closingdate20-jun-2009
- Target number of participants50
- InterventionsPatients will be treated with 2 courses of gemtuzumab ozogamicin with a 14-day interval.
- Primary outcomeOverall response rate.
- Secondary outcome1. 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.
- TimepointsPatients will be evaluated after 2 courses of treatment.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD, PhD C.M. Zwaan
- CONTACT for SCIENTIFIC QUERIESMD, PhD C.M. Zwaan
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summarySummary:
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.
- Main changes (audit trail)
- RECORD20-feb-2009 - 14-sep-2009


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