Treatment of Acute Leukemia Relapse After Allotransplantation

University of Bergen

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.

Study type: Interventional

Funder types: Other

Identifiers

NCT01369368

Allo-Relapse-2011

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Description:

Azacitidine, valproic acid, all-trans retinoic acid, hydroxyurea, eventually donor leukocyte infusions

Treatment:

Drug: Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.