Treatment of acute leukemia relapse after stem cell transplantation from healthy donors
- Conditions
- Allotransplanted patients with early acute leukemia repse (within 1 year after transplant)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-002689-19-NO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- Not specified
?AML diagnosed according to the WHO criteria, and relapse diagnosed within one year after allogeneic stem cell transplantation
?Blood and marrow samples according to the protocol being possible
?No intolerance or allergy to valproic acid, ATRA, 5-azacitidine or hydroxyurea
?Exected survival at least 4 weeks
?No expected drug interactions
?Informed consent possible
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients will be excluded from the study if they meet any of the following criteria:
•Intolerance to valproic acid, ATRA, azacytidine or hydroxyurea.
•Serious kidney (serum kreatinine increased more than 4 times above the upper normal level) or liver disease (liver enzymes increased more than 5 times above the upper normal levels).
•Informed consent not possible.
•Previous pancreatitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Clinical effect of a therapeutic intervention;Secondary Objective: Survival after treatment;Primary end point(s): Disease stabilization;Timepoint(s) of evaluation of this end point: Within the first 2 years after incluusion, this evaluation will then include time to progression
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Within 2 years after inclusion;Secondary end point(s): Survival