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

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05290545
• Other study ID #: Haplo+Cord vs Haplo-2022
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xiangzong Zeng
• Phone: +86-020-62787883
• Email: gdzxz1990[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancies
• Hematopoietic Stem Cell Transplantation
• Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Anhui Provincial People's Hospital Affiliated to University of Science and Technology of China, The First People's Hospital of Chenzhou, The First People's Hospital of Guangzhou, The Seventh Affiliated Hospital of Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)		1 year
Secondary	Relapse rate		1 year
Secondary	Overall survival (OS)		1 year
Secondary	The cumulative incidence of hematopoietic engraftment.	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
Secondary	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
Secondary	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