Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT
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|ClinicalTrials.gov Identifier: NCT03530085|
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Allogeneic Hematopoietic Stem Cell Transplantation Conditioning Elderly||Drug: Decitabine Drug: Busulfan (BU) Drug: Fludarabine(Flu)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation|
|Actual Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||April 1, 2022|
Experimental: Dec+Flu+Bu Conditioning Regimen
For AML patients older than 60 years in CR, Decitabine+ Fludarabine+Busulfan conditioning regimen was used (Decitabine 20mg/m2/day on days -12 to -8；Fludarabine(Flu) 30mg/m2/day on days -5 to -2；Busulfan (BU) 3.2 mg/kg/day on days -5 to -4).
Decitabine was administered at 20mg/m2/day on days -12 to -8.
Drug: Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.
Fludarabine(Flu) was administered at 30mg/m2/day on days -5 to -2.
- overall survival (OS) [ Time Frame: 2 year ]
- disease-free survival (DFS) [ Time Frame: 2 year ]
- relapse [ Time Frame: 2 year ]
- transplant-related mortality (TRM) [ Time Frame: 2 year ]
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): NCT03530085
|Contact: Li Xuanfirstname.lastname@example.org|
|Department of Hematology,Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Li Xuan +86-020-62787883 email@example.com|
|Principal Investigator: Qifa Liu|
|Principal Investigator:||Qifa Liu||Department of Hematology,Nanfang Hospital|