Treatment of Acute Leukemia Relapse After Allotransplantation
Phase 1
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Drug: Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.
- Registration Number
- NCT01369368
- Lead Sponsor
- University of Bergen
- Brief Summary
Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- AML relapse within one year after transplantation
- Blood and marrow sampling being possible
- Expected survival at least 4 weeks
- No expected drug interactions
- Informed consent possible
Exclusion Criteria
- Intolerance to any study drug
- Serious kidney or liver disease
- Informed consent not possible
- Previous pancreatitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions. Azacitidine, valproic acid, all-trans retinoic acid, hydroxyurea, eventually donor leukocyte infusions
- Primary Outcome Measures
Name Time Method Disease stabilization 5 years Strict criteria defined in the protocol.
- Secondary Outcome Measures
Name Time Method Survival 5 years
Trial Locations
- Locations (1)
Haukeland University Hospital
🇳🇴Bergen, Norway