Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

February 28, 2018

Study Completion Date

April 30, 2019

Conditions
Acute Lymphoblastic Leukemia
Interventions
PROCEDURE

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.

DRUG

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.

Trial Locations (5)

100044

Aerospace Center Hospital, Beijing

Unknown

Wuhan Union Hospital, Wuhan

The First Affiliated Hospital of Soochow University, Suzhou

General Hospital of PLA, Beijing

Peking Union Hospital, Beijing

All Listed Sponsors
collaborator

Peking Union Medical College Hospital

OTHER

collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

collaborator

Chinese PLA General Hospital

OTHER

collaborator

The First Affiliated Hospital of Soochow University

OTHER

collaborator

Peking University Aerospace Center Hospital

OTHER

lead

Peking University

OTHER

NCT02042690 - Haplo-identical HSCT Versus Chemotherapy for Adult Acute Lymphoblastic Leukemia Patients | Biotech Hunter | Biotech Hunter