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

Study Timeline

• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Study Start: 2013-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24
• Primary Completion: 2017-10
• Study Completion: 2020-10

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