Clinical trial NCT05103995: Impact of Donor-recipient ABO Matching on Haploidentical Stem Cell Transplantation
Official title: Impact of Donor-recipient ABO Matching on Patients' Outcome After Peripheral Blood Stem Cell Haploidentical Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematological Malignancies
Haploidentical Stem Cell Transplantation
Keywords: haploidentical stem cell transplantation
hematological malignancies
ABO incompatibility
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Affiliated Jinhua Hospital of Zhejiang University
First posted: 2021-11-02
Enrollment: 510
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 5-year Overall Survival
timeFrame: 5 year
Secondary outcomes:
measure: 5-year Non-relapse mortality
timeFrame: 5 year
measure: 5-year cumulative incidence of chronic graft versus host disease
timeFrame: 5 year
measure: 28-day cumulative incidence of neutrophils engraftment
timeFrame: 28 day
measure: 28-day cumulative incidence of platelets engraftment
timeFrame: 28 day
measure: 365-day blood transfusion requirements
timeFrame: 365 day
measure: cumulative incidence of blood transfusion independence within 60 days after transplantation
timeFrame: 60 day
measure: the 5-year cumulative incidence of poor graft function the incidence of poor graft function
timeFrame: 5 year
measure: the 5-year cumulative incidence of graft failure
timeFrame: 5-year
measure: 100-day cumulative incidence of acute graft versus host disease
timeFrame: 100-day
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Jinhua
country: China
facility: Affiliated Jinhua hospital of Zhejiang University
state: Zhejiang
Study officials:
References: