BuCy Vs. TBICy for Allo-HSCT in T-ALL Patients

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

430

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

November 30, 2029

Study Completion Date

November 30, 2029

Conditions
T-Cell Lymphocytic LeukemiaALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONTotal Body IrradiationChemotherapy
Interventions
BIOLOGICAL

TBICy

The TBI-Cy group was administered 250 mg/m2/d oral Me-CCNU on day -8. A total of 12 Gy TBI was for each patient and fractionated dose was 2 Gy twice daily or 4Gy once daily on days -8 to -6. Occluding of the lung fields during TBI, the corresponding irradiation dose reduced to a total of 8 Gy. On day -5, the schedule was intravenous 2 g/m2 Ara-C every 12 hours. Then intravenous 1.8 g/m2 CTX once per day from days -4 to -3.

BIOLOGICAL

BuCy

The BuCy group received oral Me-CCNU 250 mg/m2/d twice daily on day -8, intravenous cytosine arabinoside (Ara-C) 2 g/m2 twice daily on day -7, intravenous Bu 3.2 mg/kg/d from days -6 to -4, and intravenous cyclophosphamide (CTX) 1.8 g/m2/d from days -3 to -2. There were no patients accepted oral Bu.

Trial Locations (1)

215000

The First Affiliated Hospital of Soochow University, Suzhou

All Listed Sponsors
collaborator

Children's Hospital of Soochow University

OTHER

collaborator

Ruijin Hospital

OTHER

collaborator

Nanfang Hospital, Southern Medical University

OTHER

collaborator

Fujian Medical University Union Hospital

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

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

OTHER

collaborator

Zhejiang University

OTHER

collaborator

Anhui Provincial Hospital

OTHER_GOV

lead

The First Affiliated Hospital of Soochow University

OTHER

NCT06673459 - BuCy Vs. TBICy for Allo-HSCT in T-ALL Patients | Biotech Hunter | Biotech Hunter