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Randomized induction and post induction therapy in older patients (>= 61 yrs of age) with acute myelocytic leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t).


- candidate number1376
- NTR NumberNTR212
- ISRCTNISRCTN77039377
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR5-sep-2005
- Secondary IDsHO43 
- Public TitleRandomized induction and post induction therapy in older patients (>= 61 yrs of age) with acute myelocytic leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t).
- Scientific TitleRandomized induction and post induction therapy in older patients (>= 61 yrs of age) with acute myelocytic leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t).
- ACRONYMHOVON 43 AML / SAKK 30/01
- hypothesisThe first hypothesis to be tested is that the outcome in arm B is better than in arm A. The second hypothesis to be tested is that the outcome in arm 2 is better than in arm 1.
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML)
- Inclusion criteria1. Age 61 years or more;
2. Subjects with a cytopathologically
confirmed diagnosis of AML (M0-M2 and M4-M7, FAB classification), or with refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >=1.5;
3. Subjects with a secondary AML progressing from antecedent myelodysplasia and biphenotypic leukemia are eligible.
Antecedent MDS refers to any antecedent hematological disease of at least 4 month duration;
4. WHO performance status <= 2;
5. Written informed consent.
- Exclusion criteria1. Previous induction treatment for AML/MDS;
2. Prior chemotherapy within 6 months of study entry;
3. Previous polycythemia rubra vera;
4. Primary myelofibrosis;
5. Blast crisis of chronic myeloid leukemia;
6. AML-FAB type M3 or AML with cytogenetic abnormality t(15;17);
7. Impaired hepatic or renal function as defined by:ALT and/or AST > 2.5 x normal valueBilirubin > 2 x normal value;
8. Serum creatinine > 2 x normal value (after adequate hydration) , (unless these are most likely caused by AML organ infiltration);
9. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.);
10. Cardiac dysfunction as defined by: myocardial infarction within the last 6 months of study entry, or reduced left ventricular function with an ejection fraction <=50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable);
11. Unstable angina;
12. Unstable cardiac arrhythmias.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-okt-2000
- planned closingdate1-nov-2005
- Target number of participants800
- InterventionsPatients will be randomized on entry for induction between:


Arm A:
Cycle I: conventional type daunomycin-cytarabine schedule; Cycle II: intermediate dose cytarabine
Arm B:
Cycle I: daunomycin at escalated dose with standard dose cytarabine;
Cycle II: intermediate dose cytarabine.


Patients attaining CR and remaining in CR after cycle II will be randomized between:


Arm 1: no further treatment.
Arm 2: 3 dosages of gemtuzumab ozogamicin (GO, Mylotarg) at 4 week intervals.


For patients with an HLA identical sibling donor, an allograft with non-myeloablative conditioning, will be available depending on the active involvement in allotransplantation per center (optional per center).
- Primary outcomeEndpoint for the comparison of induction treatment arm B with arm A:
Event-free survival (i.e., time from registration to induction failure, death or relapse whichever occurs first); the time to failure of patients with induction failure is set at one day.


Endpoint for the comparison of postinduction maintenance treatment with GO with no further treatment:
Disease-free survival measured from the date of second randomization to relapse or death from any cause.
- Secondary outcomeEndpoints for the comparison of induction treatment arm B with arm A:
1. Response and especially CR to chemotherapy cycles I and II;
2. Overall survival measured form the time of registration;
3. Disease-free interval (duration of the first CR) measured from the time of achievement of CR to day of relapse or death from any cause (whichever occurs first);
4. Probability of complete response, relapse, death in CR1, event-free survival, disease-free survival and overall survival will also be assessed in relation to age (61-70, 70-80, above 80), cytogenetic abnormalities, CD33-positivity of AML (phenotype), PgP positivity;
5. Toxicities and treatment related mortality;
6. Time to hematopoietic recovery (ANC 0.5 and 1.5 x 10^9/l; platelets 50 and 100 x 10^9/l) after each treatment cycle;
7. Number of platelet transfusions and last day of platelet transfusion after each cycle;


Endpoints for the comparison of postinduction maintenance treatment with GO with no further treatment:
8. Overall survival measured from the date of second randomisation;
9. Probability of relapse and death in first CR from date of second randomization calculated as competing risks;
10. Number and duration of hospitalization as well as transfusion requirements (red cell and platelet transfusion).
- TimepointsN/A
- Trial web sitehttp://www.hovon.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. B. L÷wenberg
- CONTACT for SCIENTIFIC QUERIESProf. Dr. B. L÷wenberg
- Sponsor/Initiator VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Koningin Wilhelmina Fonds (KWF)
- PublicationsN/A
- Brief summaryStudy phase:
phase III.


Study objectives:
evaluation of the effect of an escalated dose of Daunomycin in induction treatment. Evaluation of the effect of maintenance treatment with GO for patients in CR.


Patient population:
patients with AML except FAB M3 or t(15;17), RAEB or RAEB-t with IPSS >= 1.5, previously untreated, age >= 61 yrs.


Study design:
prospective, multicenter, randomized with randomization up front for induction treatment and randomization of patients in CR for maintenance treatment or not.


Duration of treatment:
expected duration of 2 cycles of induction treatment inclusive evaluation is about 3 months. For patients in CR, randomized to GO, the additional treatment time is between 12 and 36 weeks.
- Main changes (audit trail)
- RECORD5-sep-2005 - 15-sep-2008


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