ASCT for Relapsed APL After Molecular Remission
|Acute Promyelocytic Leukemia Relapse||Procedure: autologous hematopoietic cell transplantation||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning|
- disease free survival [ Time Frame: 3 years ]
- overall survival [ Time Frame: 3 years ]
- transplantation related mortality [ Time Frame: 3 years ]
|Study Start Date:||June 2009|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: ASCT in relapsed APL
autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission
Procedure: autologous hematopoietic cell transplantation
Autologous hematopoietic cell transplantation and condition with the following:
idarubicin 15mg/m2•d day -11 and -10; busulfan 0.8mg/kg•q6h day -6 to -3.
Once relapsed acute promyelocytic leukemia achieved molecular remission after all-trans retinoic acid (ATRA) and arsenic treatment, PBSC was mobilized and collected with further confirmation of molecular remission via RT-PCR.
Patients received autologous hematopoietic cell transplantation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907582
|Rui Jin Hospital, Shanghai JiaoTong University School of Medicine|
|Shanghai, China, 200025|
|Principal Investigator:||JIong HU, M.D.||Shanghai Rui Jin Hospital|