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| Name | Class |
|---|---|
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Hunan Provincial People's Hospital | OTHER |
| The Seventh Affiliated Hospital of Sun Yat-sen University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haplo-PBSC+Cord group | Experimental | The third party UCB will be infused the day after infusion of PBSCs from HID. |
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| Haplo-PBSC+BM group | Active Comparator | The BMSCs from the same HID will be infused the day after infusion of PBSCs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBSCs | Other | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate | 1 year | |
| Overall survival (OS) | 1 year | |
| The cumulative incidence of hematopoietic engraftment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39919775 | Derived | Yu S, Huang F, Xu N, Zhang Z, Liu C, Xu X, Fan Z, Zeng X, Liu Q, Qiu G, Xi X, Lin R, Liang X, Jiang Y, Dai M, Jin H, Li X, Wang S, Wu M, Sun J, Xuan L, Liu Q. Haploidentical peripheral blood stem cells combined with bone marrow or unrelated cord blood as grafts for haematological malignancies: an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2025 Mar;12(3):e190-e200. doi: 10.1016/S2352-3026(24)00372-7. Epub 2025 Feb 4. |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| First People's Hospital of Chenzhou |
| OTHER |
| Dongguan People's Hospital | OTHER_GOV |
| The First People's Hospital of Guangzhou | UNKNOWN |
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| Cord | Other | 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. |
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| BMSCs | Other | 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. |
|
Hematopoietic engraftment includes the time of neutrophil and platelet engraftment. Neutrophil engraftment was defined as the first of two consecutive days with an absolute neutrophil count in the peripheral blood exceeding 0.5 × 10^9/L and the platelet engraftment was defined as the first of 3 days with an absolute platelet count exceeding 20 × 10^9 /L without transfusion support. |
| 30 days post-transplantation |
| The cumulative incidence of acute graft-versus-host-disease (GVHD) | Acutue GVHD was defined according to the 1994 consensus conference on acute GVHD grading and graded from I to IV. | 100 days post-transplantation |
| The cumulative incidence of chronic GVHD | Chronic GVHD was graded as mild, moderate and severe according to the national institutes of health consensus development project on criteria for clinical trials in chronic GVHD: the 2014 diagnosis and staging working group report. | 1 year |