Clinical trial NCT05290545: Haplo-PBSC+Cord vs Haplo-PBSC+BM for Hematological Malignancies Undergoing Allo-HSCT
Official title: A Comparative Study of Haploidentical Transplantation Supported by Third-party Cord Blood and Haploidentical Transplantation in Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hematological Malignancies
Hematopoietic Stem Cell Transplantation
Keywords: Hematological malignancies
Haploidentical transplantation
Umbilical cord blood
Disease-free survival
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Guangxi Medical University
name: Hunan Provincial People's Hospital
name: The Seventh Affiliated Hospital of Sun Yat-sen University
name: First People's Hospital of Chenzhou
name: Dongguan People's Hospital
name: The First People's Hospital of Guangzhou
First posted: 2022-03-22
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 1 year
Secondary outcomes:
measure: Relapse rate
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 1 year
measure: The cumulative incidence of hematopoietic engraftment.
timeFrame: 30 days post-transplantation
measure: The cumulative incidence of acute graft-versus-host-disease (GVHD)
timeFrame: 100 days post-transplantation
measure: The cumulative incidence of chronic GVHD
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References: