Clinical trial · Interventional
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
NCT05290545CI-TRIAL-00079762completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMSCs | Other | — | UNRESOLVED |
| Cord | Other | — | UNRESOLVED |
| PBSCs | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Haplo-PBSC+Cord group
- description
- The third party UCB will be infused the day after infusion of PBSCs from HID.
- interventionNames
- Other: PBSCs
- Other: Cord
- type
- ACTIVE_COMPARATOR
- label
- Haplo-PBSC+BM group
- description
- The BMSCs from the same HID will be infused the day after infusion of PBSCs.
- interventionNames
- Other: PBSCs
- Other: BMSCs
Primary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDYu 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. PMID 39919775