Treatment of Acute Leukemia Relapse After Allotransplantation
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Acute myeloid leukemia, Allogeneic stem cell transplantation, Relapse, Disease stabilization, survival
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Haukeland University Hospital
Bergen, Norway
Status: Recruiting
Start Date
August 2013
Completion Date
October 2020
Sponsors
University of Bergen
Source
University of Bergen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page