131
Participants
Start Date
July 31, 2014
Primary Completion Date
February 28, 2018
Study Completion Date
April 30, 2019
Haplo-identical HSCT
Haplo-identical Protocol: myeloablative human leukocyte antigen (HLA) haploidentical stem cell transplantation (haplo-SCT) using pretransplant ATG and granulocyte colony-stimulating factor (G-CSF)-stimulated grafts (ATG+G-CSF) GVHD prevention regimen: CSA/MMF/MTX, CSA 1.25mg/kg/d, i.v administrated in two doses from day -109 until bowel function returned to normal, at which time patients receive oral CSA until 12months after HRD-HSC and then gradually tapered. Every 12h, 0.5g MMF(0.25g for children) was administrated orally from day -10 to +30 and subsequently 0.25g from days +30 to +60. MTX was administrated at a dose of 15mg/m2 on day +1 and 10mg/m2 on days +3,+6, and +11.
Chemotherapy
Patients receive 6 cycles of consolidation chemotherapy after randomization, including Hyper-CVAD-B regimen-Hyper-CVAD-A regimen/Hyper-CVAD-B regimen/Hyper-CVAD-A regimen/Hyper-CVAD-B regimen/Hyper-CVAD-A regimen.Maintenance treatment includes MTX 20mg/m2/w,po,6-mercaptopurine 60 mg/m2/d,po,d1-d28,VP(VDS 4mg,d1, Prednisone 1mg/kg d1-7) every one month for 2 years.
Aerospace Center Hospital, Beijing
Wuhan Union Hospital, Wuhan
The First Affiliated Hospital of Soochow University, Suzhou
General Hospital of PLA, Beijing
Peking Union Hospital, Beijing
Peking Union Medical College Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Chinese PLA General Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Peking University Aerospace Center Hospital
OTHER
Peking University
OTHER