Treatment of Acute Leukemia Relapse After Allotransplantation

• Status: Unknown status
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bergen
• Treatments: Azacitidine; Tretinoin; Valproic Acid

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