drugset / Trial / NCT01369368

Treatment of Acute Leukemia Relapse After Allotransplantation

NCT01369368

Phase 1/2 Unknown 20 enrolled University of Bergen
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-08
Primary completion
2017-10
Completion
2020-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 100 mg Subcutaneous
Subject Hydroxurea Unknown 1 g
Subject Tretinoin Small molecule 22.5 mg/m2
Subject Valproic Acid Small molecule