Allotransplanted patients with early acute leukemia repse (within 1 year after transplant)
Conditions
Interventions
Trade Name: Tretinon
all-trans retinoic acid. No marketing authorization in Norway but in other European countries. The formula Vesanoid from Roche will be used
Product Name: All-trans retinoic acid (Vesanoid)
Pharmaceuti
Sponsors
Haukeland University Hospital
Eligibility
Inclusion criteria
Inclusion criteria: ?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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Survival;Timepoint(s) of evaluation of this end point: Within 2 years after inclusion | — |
Countries
Norway
Outcome results
None listed