Impact of Donor-recipient ABO Matching on Haploidentical Stem Cell Transplantation

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT05103995
Collaborator
Affiliated Jinhua Hospital of Zhejiang University (Other)
510
Enrollment
2
Locations
105
Actual Duration (Months)
255
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation

Condition or DiseaseIntervention/TreatmentPhase
  • Other: no intervention

Detailed Description

The impact of donor-recipient ABO compatibility on transplant outcomes had been evaluated in different transplant settings, but had shown different results. The investigators set out to investigate the impact of ABO incompatibility on post-transplant outcomes, engraftment kinetics and blood product requirements, transfusion independence, the incidence of poor graft function (PGF) in anti-T-lymphocyte globulin (ATG) based haplo-SCT with PBSC grafts.

Study Design

Study Type:
Observational
Actual Enrollment :
510 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Donor-recipient ABO Matching on Patients' Outcome After Peripheral Blood Stem Cell Haploidentical Stem Cell Transplantation
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Mar 31, 2019
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

ArmIntervention/Treatment
ABO matched

Donor-recipient ABO matched

Other: no intervention
no intervention, just observation

Minor incompatibility

Donor-recipient minor incompatibility

Other: no intervention
no intervention, just observation

Major incompatibility

Donor-recipient major incompatibility

Other: no intervention
no intervention, just observation

Bidirectional incompatibility

Donor-recipient bidirectional incompatibility

Other: no intervention
no intervention, just observation

Outcome Measures

Primary Outcome Measures

  1. 5-year Overall Survival [5 year]

    5-year Overall Survival

Secondary Outcome Measures

  1. 5-year Non-relapse mortality [5 year]

    5-year non-relapse mortality

  2. 5-year cumulative incidence of chronic graft versus host disease [5 year]

    5-year cumulative incidence of chronic graft versus host disease

  3. 28-day cumulative incidence of neutrophils engraftment [28 day]

    numbers of participants achieved neutrophils engraftment at 28 days post transplantation

  4. 28-day cumulative incidence of platelets engraftment [28 day]

    numbers of participants achieved platelets engraftment at 28 days post transplantation

  5. 365-day blood transfusion requirements [365 day]

    numbers of blood products transfusion within 365-day after transplantation

  6. cumulative incidence of blood transfusion independence within 60 days after transplantation [60 day]

    numbers of participants achieved blood transfusion independence within 60 days after transplantation

  7. the 5-year cumulative incidence of poor graft function the incidence of poor graft function [5 year]

    numbers of participants occurred poor graft function 5 years post transplantation

  8. the 5-year cumulative incidence of graft failure [5-year]

    numbers of participants occurred graft failure 5 years post transplantation

  9. 100-day cumulative incidence of acute graft versus host disease [100-day]

    100-day cumulative incidence of acute graft versus host disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. The subjects or their legal representatives signed the informed consent before the clinical study. 2. Subjects aged 15-70 years. 3. Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation 4. Patients have no suitable HLA identical sibling donor 5.Patients with malignant hematological diseases plan to receive HLA haploidentical stem cell transplantation 6. Subjects with ECoG score of 0-2.
Exclusion Criteria:

1.Patients have suitable HLA identical sibling donor 2. Patients with severe liver and kidney function (alanine aminotransferase > 2.5 times of the upper normal limit, serum creatinine > 1.5 times of the upper normal limit), cardiopulmonary dysfunction (cardiac function NYHA III / IV, cardiac ejection fraction < 50%, severe obstructive or restrictive ventilation dysfunction); 3. Patients with active infection; 4. patients diagnosed with aplastic anemia before transplantation or died within 2 months after transplantation; 5. Subjects with ECoG score > 2; 6. Patients with secondary tumor; 7. Patients who cannot independently choose to enter or exit clinical trials due to serious central nervous system disease or mental disease.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1The first Affiliated Hospital of Zhejiang UniversityHangzhouZhejiangChina310000
2Affiliated Jinhua hospital of Zhejiang UniversityJinhuaZhejiangChina

Sponsors and Collaborators

  • First Affiliated Hospital of Zhejiang University
  • Affiliated Jinhua Hospital of Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yi Luo, Principal Investigator, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier:
NCT05103995
Other Study ID Numbers:
  • ZJU-haplo-abo
First Posted:
Nov 2, 2021
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yi Luo, Principal Investigator, First Affiliated Hospital of Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2021