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Beijing Protocol in Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT

P

Peking University

Status

Enrolling

Conditions

Hematologic Malignancy
Stem Cell Transplant Complications

Treatments

Combination Product: Beijing protocol

Study type

Observational

Funder types

Other

Identifiers

NCT05921318
Highly HLA mismatched HSCT

Details and patient eligibility

About

The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.

Full description

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative procedure for patients with hematological malignancies.Donor-recipient human leukocyte antigen (HLA) compatibility plays a key role in successful allo-HSCT as HLA-matching has a direct impact on the risk of GvHD, non-relapse mortality (NRM), and survival. Suitable, matched or haploidentical donors are not always available or accessible, even in the era of the international registries.Therefore, there is a need for new strategies that could negate the barrier of HLA-mismatching, allowing allo-HSCT from traditionally prohibitive highly mismatched donors.The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.

Enrollment

20 estimated patients

Sex

All

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • hematologic malignancy patients
  • patients eligible for the transplantation of allogeneic hematopoietic stem cells;
  • patients unavailable with HLA matched donor or related haploidentical donor
  • voluntary participation in this study and signing the informed consent form.

Exclusion criteria

  • Patients with the severe infections;
  • Pregnant or lactating women
  • Patients who are not eligible for hematopoietic stem cell transplantation;
  • Patients who are enrolled in other clinical trials within 1 month;
  • Patients who may not be able to complete the study for other reasons, or may be considered by the investigator not suitable to participate in the study;
  • Patients unable to properly understand or refusing to accept the informed consent form.

Trial design

20 participants in 1 patient group

more than 5/10 HLA-mismatched allo-HSCT
Description:
more than 5/10 HLA-mismatched allo-HSCT
Treatment:
Combination Product: Beijing protocol

Trial contacts and locations

1

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Central trial contact

Yu Wang, Prof.

Data sourced from clinicaltrials.gov

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