|- candidate number||5738|
|- NTR Number||NTR1810|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mei-2009|
|- Secondary IDs||2008-001290-15 |
|- Public Title||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). |
|- Scientific Title||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).|
|- ACRONYM||HOVON 97 AML|
|- hypothesis||The hypothesis to be tested is that the outcome in arm B is better than in arm A.|
|- Healt Condition(s) or Problem(s) studied||Acute Myeloid Leukemia (AML), RAEB|
|- Inclusion criteria||1. 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 criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2009|
|- planned closingdate|
|- Target number of participants||126|
|- Interventions||Patients 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 outcome||Disease-free survival measured from the date of randomization to relapse or death from any cause whichever comes first. |
|- Secondary outcome||1. 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.
|- Timepoints||At 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 site||www.hovon.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. G. Huls|
|- CONTACT for SCIENTIFIC QUERIES||Dr. G. Huls|
|- Sponsor/Initiator ||HOVON Data Center, Erasmus Medical Center, Daniel den Hoed Cancer Center |
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society, HOVON, Celgene |
|- Brief summary||Study 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)|
|- RECORD||12-mei-2009 - 30-sep-2009|