Study for the treatment of patients who have been succesfully treated for leukemia before, to keep the patient leukemia free

• Conditions: Acute myeloid leukemia; MedDRA version: 16.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-001290-15-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-29
• Last Update Posted: 22 July 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 126

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, appendix A), or
(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
Note: Subjects with a secondary AML progressing from antecedent myelodysplasia and biphenotypic leukaemia are eligible.
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. Of note: also patients who are treated according to one of these protocols but were not formally included in these studies are eligible for HOVON97)
4) Hematological recovery, i.e. ANC ³ 0.5 x 109/l and platelets ³ 50 x 109/l
5) WHO performance status <= 2
6) Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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, or
b) Reduced left ventricular function with an ejection fraction <50%
c) Unstable angina
d) Unstable cardiac arrhythmias

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified