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Randomized maintenance therapy with Azacitidine (Vidaza) in older patients (>= 60 years of age) with acute myeloid leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t).


- candidate number5738
- NTR NumberNTR1810
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-mei-2009
- Secondary IDs2008-001290-15  
- Public TitleRandomized maintenance therapy with Azacitidine (Vidaza) in older patients (>= 60 years of age) with acute myeloid leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t).
- Scientific TitleRandomized maintenance therapy with Azacitidine (Vidaza) in older patients (>= 60 years of age) with acute myeloid leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t).
- ACRONYMHOVON 97 AML
- hypothesisThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML), RAEB
- Inclusion criteria1. Age 60 years or more;
2. Subjects with a cytopathologically confirmed diagnosis of:
A. AML (M0-M2 and M4-M7, FAB classification);
B. 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. Less than 5% bone marrow blasts and absence of Auer rods after 2 cycles of induction therapy (this induction therapy can be according to HOVON81, HOVON92 or similar protocols);
4. Hematological recovery, i.e. ANC >= 0.5 x 109/l and platelets >= 50 x 109/l;
5. WHO performance status <= 2;
6. Written informed consent.
- Exclusion criteria1. Extramedullary disease;
2. Planned allogeneic hematopoietic cell transplantation;
3. Previous polycythaemia 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:
A. ALT and/or AST > 2.5 x normal value;
B. Bilirubin > 2 x normal value;
C. Serum creatinin > 2 x normal value (after adequate hydration).
8. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
9. Cardiac dysfunction as defined by:
A. Myocardial infarction within the last 6 months of study entry;
B. Reduced left ventricular function with an ejection fraction <50% as measured by MUGA scan or echocardiogram;
C. Unstable angina.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2009
- planned closingdate
- Target number of participants126
- InterventionsPatients will be randomized between either maintenance therapy with Azacitidine or observation. Patients will receive maintenance treatment until relapse, for a maximum of 12 cycles.
- Primary outcomeDisease-free survival measured from the date of randomization to relapse or death from any cause whichever comes first.
- Secondary outcome1. Overall survival measured from the date of randomization;
2. Probability of relapse and death after inclusion from date of randomization calculated as competing risks;
3. Number and duration of hospitalization as well as transfusion requirements (red cell and platelet transfusion);
4. Adverse events.
- TimepointsAt entry, during treatment every 4 weeks (or before start next cycle), in follow up every 4 weeks until relapse and thereafter every 4-8 weeks.
- Trial web sitewww.hovon.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G. Huls
- CONTACT for SCIENTIFIC QUERIESDr. G. Huls
- Sponsor/Initiator HOVON Data Center, Erasmus Medical Center, Daniel den Hoed Cancer Center
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society, HOVON, Celgene
- PublicationsN/A
- Brief summaryStudy phase: Phase 3.
Study objective: Evaluation of the effect of maintenance treatment with Azacitidine (Vidaza) for patients with <5% bone marrow blasts after 2 cycles of chemotherapy.
Patient population: Patients with AML except FAB M3 or t(15;17), and RAEB or RAEB-t with IPSS >= 1.5, age >= 60 yrs.
Study design: Prospective, multicenter, randomized phase III trial. Patients with <5% bone marrow blasts after 2 cycles of chemotherapy and who are not eligible for allogeneic hematopoietic cell transplantation, will be randomized for maintenance treatment or observation.
Duration of treatment: Patients randomized to Azacitidine (Vidaza), will receive maintenance treatment until relapse, for a maximum of 12 cycles. All patients will be followed for a maximum of 10 years after randomization.
- Main changes (audit trail)
- RECORD12-mei-2009 - 30-sep-2009


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