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

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 3

Conditions: Hematological Malignancies; Hematopoietic Stem Cell Transplantation

Treatments: Other: Cord; Other: BMSCs; Other: PBSCs

Study type: Interventional

Funder types: Other

Identifiers

NCT05290545

NFEC-2021-126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 314 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with hematologic malignancies undergoing first HID allo-HSCT
• Age 18 to 65 years old with ECOG performance status 0-2
• Received myeloablative conditioning regimens
• Sign informed consent form, have the ability to comply with study and follow-up procedures

Exclusion criteria

• Received PBSCs as only grafts
• Acute leukemia transformed from a myeloproliferative tumor
• Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
• Respiratory failure ( PaO2 ≤60mmHg)
• Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase >2 times the upper limit of normal)
• Renal dysfunction (creatinine clearance rate < 30 mL/min)
• ECOG performance status 3, 4 or 5
• With any conditions not suitable for the trial (investigators' decision)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

314 participants in 2 patient groups

Haplo-PBSC+Cord group

Experimental group

Description:

The third party UCB will be infused the day after infusion of PBSCs from HID.

Treatment:

Other: Cord

Other: PBSCs

Haplo-PBSC+BM group

Active Comparator group

Description:

The BMSCs from the same HID will be infused the day after infusion of PBSCs.

Treatment:

Other: BMSCs

Other: PBSCs