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Treatment of Acute Leukemia Relapse After Allotransplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01369368
Recruitment Status : Recruiting
First Posted : June 8, 2011
Last Update Posted : June 24, 2015
Information provided by (Responsible Party):
Øystein Bruserud, 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions. Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation: Disease Stabilization Through Chemotherapy, Immunomodulatory Treatment and Immunotherapy
Study Start Date : August 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: 1
Azacitidine, valproic acid, all-trans retinoic acid, hydroxyurea, eventually donor leukocyte infusions
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.
Other Name: Give as repeated cycles with 5 weeks intervals. Donor leukocyte infusions are allowed from cycle 2.

Primary Outcome Measures :
  1. Disease stabilization [ Time Frame: 5 years ]
    Strict criteria defined in the protocol.

Secondary Outcome Measures :
  1. Survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01369368

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Contact: Oystein Bruserud, MD 0047 55975000
Contact: Bjorn Tore Gjertsen, MD 0047 55972997

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Haukeland University Hospital Recruiting
Bergen, Norway, N-5021
Principal Investigator: Oystein Bruserud, MD         
Sponsors and Collaborators
University of Bergen
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Responsible Party: Øystein Bruserud, Professor, University of Bergen Identifier: NCT01369368    
Other Study ID Numbers: Allo-Relapse-2011
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015
Keywords provided by Øystein Bruserud, University of Bergen:
Acute myeloid leukemia
Allogeneic stem cell transplantation
Disease stabilization, survival
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Valproic Acid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs