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

Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103995
• Other study ID #: ZJU-haplo-abo
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: October 1, 2021
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Haploidentical Stem Cell Transplantation
• Hematologic Neoplasms
• Hematological Malignancies
• Neoplasms

Intervention

Other:
• no intervention
no intervention, just observation

Locations

Country	Name	City	State
China	The first Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Affiliated Jinhua hospital of Zhejiang University	Jinhua	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	Affiliated Jinhua Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year Overall Survival	5-year Overall Survival	5 year
Secondary	5-year Non-relapse mortality	5-year non-relapse mortality	5 year
Secondary	5-year cumulative incidence of chronic graft versus host disease	5-year cumulative incidence of chronic graft versus host disease	5 year
Secondary	28-day cumulative incidence of neutrophils engraftment	numbers of participants achieved neutrophils engraftment at 28 days post transplantation	28 day
Secondary	28-day cumulative incidence of platelets engraftment	numbers of participants achieved platelets engraftment at 28 days post transplantation	28 day
Secondary	365-day blood transfusion requirements	numbers of blood products transfusion within 365-day after transplantation	365 day
Secondary	cumulative incidence of blood transfusion independence within 60 days after transplantation	numbers of participants achieved blood transfusion independence within 60 days after transplantation	60 day
Secondary	the 5-year cumulative incidence of poor graft function the incidence of poor graft function	numbers of participants occurred poor graft function 5 years post transplantation	5 year
Secondary	the 5-year cumulative incidence of graft failure	numbers of participants occurred graft failure 5 years post transplantation	5-year
Secondary	100-day cumulative incidence of acute graft versus host disease	100-day cumulative incidence of acute graft versus host disease	100-day