Clinical Trial: ASCT for Relapsed APL After Molecular Remission
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning
Brief Summary: For relapsed acute promyelocytic leukemia after all-trans retinoic acid (ATRA) and arsenic treatment, remission can be achieved by chemotherapy with ATRA and/or arsenic and addition of mylotarg. Autologous hematopoietic cell transplantation using a polymerase chain reaction (PCR) negative graft is important treatment option to obtain sustainable remission. This study is to test the efficacy and the safety of conditioning regimen with idarubicin and busulfan for relapsed Acute Promyelocytic Leukemia (APL).
Detailed Summary:
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.
Sponsor: Shanghai Jiao Tong University School of Medicine
Current Primary Outcome: disease free survival [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- overall survival [ Time Frame: 3 years ]
- transplantation related mortality [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Shanghai Jiao Tong University School of Medicine
Dates:
Date Received: May 21, 2009
Date Started: June 2009
Date Completion:
Last Updated: December 1, 2014
Last Verified: November 2014
