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

Zhejiang University logo

Zhejiang University

Status

Completed

Conditions

Haploidentical Stem Cell Transplantation
Hematological Malignancies

Treatments

Other: no intervention

Study type

Observational

Funder types

Other

Identifiers

NCT05103995
ZJU-haplo-abo

Details and patient eligibility

About

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

Full 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.

Enrollment

510 patients

Sex

All

Ages

15 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

510 participants in 4 patient groups

ABO matched
Description:
Donor-recipient ABO matched
Treatment:
Other: no intervention
Minor incompatibility
Description:
Donor-recipient minor incompatibility
Treatment:
Other: no intervention
Major incompatibility
Description:
Donor-recipient major incompatibility
Treatment:
Other: no intervention
Bidirectional incompatibility
Description:
Donor-recipient bidirectional incompatibility
Treatment:
Other: no intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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