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

NCT05290545 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2024-08-13

No results posted yet for this study

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.

Conditions

Interventions

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER
  • Hunan Provincial People's Hospital

    collaborator OTHER
  • The Seventh Affiliated Hospital of Sun Yat-sen University

    collaborator OTHER
  • First People's Hospital of Chenzhou

    collaborator OTHER
  • Dongguan People's Hospital

    collaborator OTHER_GOV
  • The First People's Hospital of Guangzhou

    collaborator UNKNOWN
  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Qifa Liu · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2023-01-02
Completion
2024-03-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05290545 on ClinicalTrials.gov