NCT01369368

Treatment of Acute Leukemia Relapse After Allotransplantation

Treatment of Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation: Disease Stabilization Through Chemotherapy, Immunomodulatory Treatment and Immunotherapy

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Bergen · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.	Azacitidine 100 mg day 1-3 in each cycle Valproic acid, continuous therapy from day 1 All-trans retinoic acid 22.5 mg/m2 twice daily day 1-14 in each cycle Hydroxurea 500 mg initially eventually increased to 1 g daily. Eventually donor leukocyte infusions on day 10 from the second cycle.

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-10-01
• Completion: 2020-10-01
• First posted: 2011-06-08
• Last updated: 2015-06-24

Locations

1 site across 1 country: Norway