NCT05290545

Haplo-PBSC+Cord vs Haplo-PBSC+BM for Hematological Malignancies Undergoing Allo-HSCT

A Comparative Study of Haploidentical Transplantation Supported by Third-party Cord Blood and Haploidentical Transplantation in Hematological Malignancies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to explore whether the combination with umbilical cord blood (UCB) is associated with superior disease-free survival (DFS) in the setting of haploidentical donors (HID) transplantation.

Detailed description

The main causes of allogeneic hematopoietic stem cell transplantation (allo-HSCT) failure are primary disease relapse and transplant-related complications, especially relapse. In recent years, with the development of transplantation technology, alternative donors such as HID and UCB have been widely used. But, these alternative donors are associated with high incidences of transplant-related complications and mortalities when compared with human leukocyte antigen (HLA)-matched donors. Some studies suggeted that mixed grafts might overcome the disadvantages of a single alternative graft. UCB transplant (UCBT) supported by third-party HID or HID transplants supported by third-party UCB has been reported to have rapid engraftment and low incidences of graft-versus-host-disease (GVHD), making survival improvement. However, most of these results came from single-arm studies. The comparative studies between haplo-PBSC+Cord and haplo-PBSC+BM are scarce in the setting of HID transplantation. In a retrospective study, the investigators found haplo-PBSC+Cord transplantation has superior DFS than haplo-PBSC+BM in hematological malignancies. To further confirmed this conclusion, the investigators plan to conduct a prospective, multicenter, phase 3 randomized controlled trial.

Conditions

• Hematological Malignancies
• Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
OTHER	PBSCs	PBSCs harvest is performed from day 5 of G-CSF to obtain at least 7.0×10\^8 total nucleated cells/kg recipient ideal body weight.
OTHER	Cord	The criteria for cord selection included the following: (1) ≥3 of 6 HLA loci , (2) blood type matches, (3) contained a minimum cell count of 0.3×10\^8 nucleated cells/kg and 0.15×10\^6 CD34-positive cells/kg before freezing. The third party UCB will be infused the day after infusion of PBSCs.
OTHER	BMSCs	BMSCs of donor will be collected and infused at least 0.5×10\^8 total nucleated cells/kg recipient ideal body weight the day after PBSCs infusion.

Timeline

• Start date: 2022-02-15
• Primary completion: 2023-01-02
• Completion: 2024-03-30
• First posted: 2022-03-22
• Last updated: 2024-08-13

Locations

1 site across 1 country: China