Treatment of Acute Leukemia Relapse After Allotransplantation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2011 by University of Bergen
Sponsor:
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT01369368
First received: June 7, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Disease stabilization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Strict criteria defined in the protocol.


Secondary Outcome Measures:
  • Survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369368

Contacts
Contact: Oystein Bruserud, MD 0047 55975000 oystein.bruserud@haukeland.no
Contact: Bjorn Tore Gjertsen, MD 0047 55972997 bjorn.gjertsen@med.uib.no

Locations
Norway
Haukeland University Hospital Not yet recruiting
Bergen, Norway, N-5021
Principal Investigator: Oystein Bruserud, MD         
Sponsors and Collaborators
University of Bergen
  More Information

No publications provided

Responsible Party: Oystein Bruserud, professor, consultant, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01369368     History of Changes
Other Study ID Numbers: Allo-Relapse-2011
Study First Received: June 7, 2011
Last Updated: June 7, 2011
Health Authority: Norway: Innovest, Haukeland University Hospital, N-5021 Bergen, Norway

Keywords provided by University of Bergen:
Acute myeloid leukemia
Allogeneic stem cell transplantation
Relapse
Disease stabilization, survival

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Valproic Acid
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Anticonvulsants
Central Nervous System Agents
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014