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 ]
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 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|