NCT05290545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

August 13, 2024

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

March 3, 2022

Last Update Submit

August 12, 2024

Conditions

Hematological MalignanciesHematopoietic Stem Cell Transplantation

Keywords

Hematological malignanciesHaploidentical transplantationUmbilical cord bloodDisease-free survival

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS)

    1 year

Secondary Outcomes (5)

  • Relapse rate

    1 year

  • Overall survival (OS)

    1 year

  • The cumulative incidence of hematopoietic engraftment.

    30 days post-transplantation

  • The cumulative incidence of acute graft-versus-host-disease (GVHD)

    100 days post-transplantation

  • The cumulative incidence of chronic GVHD

    1 year

Study Arms (2)

Haplo-PBSC+Cord group

EXPERIMENTAL

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

Other: PBSCsOther: Cord

Haplo-PBSC+BM group

ACTIVE COMPARATOR

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

Other: PBSCsOther: BMSCs

Interventions

PBSCsOTHER

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.

Haplo-PBSC+BM groupHaplo-PBSC+Cord group
CordOTHER

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.

Haplo-PBSC+Cord group
BMSCsOTHER

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.

Haplo-PBSC+BM group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

  • 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.

    PMID: 39919775DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Qifa Liu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 22, 2022

Study Start

February 15, 2022

Primary Completion

January 2, 2023

Study Completion

March 30, 2024

Last Updated

August 13, 2024

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)