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

NCT ID: NCT05103995

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

510 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2021-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Hematological Malignancies Haploidentical Stem Cell Transplantation

Keywords

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haploidentical stem cell transplantation hematological malignancies ABO incompatibility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ABO matched

Donor-recipient ABO matched

no intervention

Intervention Type OTHER

no intervention, just observation

Minor incompatibility

Donor-recipient minor incompatibility

no intervention

Intervention Type OTHER

no intervention, just observation

Major incompatibility

Donor-recipient major incompatibility

no intervention

Intervention Type OTHER

no intervention, just observation

Bidirectional incompatibility

Donor-recipient bidirectional incompatibility

no intervention

Intervention Type OTHER

no intervention, just observation

Interventions

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no intervention

no intervention, just observation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Jinhua Hospital of Zhejiang University

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Yi Luo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The first Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Affiliated Jinhua hospital of Zhejiang University

Jinhua, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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ZJU-haplo-abo

Identifier Type: -

Identifier Source: org_study_id