ASCT for Relapsed APL After Molecular Remission
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00907582|
Recruitment Status : Terminated (slow recruitment)
First Posted : May 22, 2009
Last Update Posted : December 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Promyelocytic Leukemia Relapse||Procedure: autologous hematopoietic cell transplantation||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
U.S. FDA Resources
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.
- disease free survival [ Time Frame: 3 years ]
- overall survival [ Time Frame: 3 years ]
- transplantation related mortality [ Time Frame: 3 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): NCT00907582
|Rui Jin Hospital, Shanghai JiaoTong University School of Medicine|
|Shanghai, China, 200025|
|Principal Investigator:||JIong HU, M.D.||Shanghai Rui Jin Hospital|