NCT00907582

ASCT for Relapsed APL After Molecular Remission

Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Acute Promyelocytic Leukemia
• Relapse

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2009-05-22
• Last updated: 2014-12-02

Locations

1 site across 1 country: China