No registrations found.
ID
Source
Brief title
Health condition
AML except FAB M3 or t(15;17), and RAEB or RAEB-t with IPSS >= 1.5, age >= 60 yrs.
Sponsors and support
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
Intervention
Outcome measures
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.
Background 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.
Study objective
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Study design
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.
Intervention
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.
G. Huls
UMCG, Department of Hematology
Groningen 9700 RB
The Netherlands
+31 (0)50 3612354
g.huls@int.umcg.nl
G. Huls
UMCG, Department of Hematology
Groningen 9700 RB
The Netherlands
+31 (0)50 3612354
g.huls@int.umcg.nl
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.
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 | NL1700 |
| NTR-old | NTR1810 |
| Other | : 2008-001290-15 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |