Treatment of Acute Leukemia Relapse After Allotransplantation
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|ClinicalTrials.gov Identifier: NCT01369368|
Recruitment Status : Recruiting
First Posted : June 8, 2011
Last Update Posted : June 24, 2015
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Disease stabilization [ Time Frame: 5 years ]Strict criteria defined in the protocol.
- Survival [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369368
|Contact: Oystein Bruserud, MD||0047 firstname.lastname@example.org|
|Contact: Bjorn Tore Gjertsen, MD||0047 email@example.com|
|Haukeland University Hospital||Recruiting|
|Bergen, Norway, N-5021|
|Principal Investigator: Oystein Bruserud, MD|