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NCT Number: NCT05103995

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

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

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Key information

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The first Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

no intervention, just observation

Primary outcomes

  1. 5-year Overall Survival

    Time frame: 5 year

    5-year Overall Survival

Secondary outcomes

  1. 5-year Non-relapse mortality

    Time frame: 5 year

    5-year non-relapse mortality

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

    Time frame: 5 year

    5-year cumulative incidence of chronic graft versus host disease

  3. 28-day cumulative incidence of neutrophils engraftment

    Time frame: 28 day

    numbers of participants achieved neutrophils engraftment at 28 days post transplantation

  4. 28-day cumulative incidence of platelets engraftment

    Time frame: 28 day

    numbers of participants achieved platelets engraftment at 28 days post transplantation

  5. 365-day blood transfusion requirements

    Time frame: 365 day

    numbers of blood products transfusion within 365-day after transplantation

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

    Time frame: 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

    Time frame: 5 year

    numbers of participants occurred poor graft function 5 years post transplantation

  8. the 5-year cumulative incidence of graft failure

    Time frame: 5-year

    numbers of participants occurred graft failure 5 years post transplantation

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

    Time frame: 100-day

    100-day cumulative incidence of acute graft versus host disease

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

  • Affiliated Jinhua Hospital of Zhejiang University

Registry information

Official study title

Impact of Donor-recipient ABO Matching on Patients' Outcome After Peripheral Blood Stem Cell Haploidentical Stem Cell Transplantation

Important dates

Study start
2013
Primary completion
2019
Study completion
2021
First posted
Nov 2, 2021
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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