Clinical trial NCT05921318: Beijing Protocol in Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT
Official title: The Safety and Efficiency of Beijing Protocol in Malignant Hematologic Disease Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Malignancy
Stem Cell Transplant Complications
Keywords: allogenetic hematopoietic stem cell transplant
HLA locus
Hematologic Malignancy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 20
Sex: ALL
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: Patient with hematologic malignancy，unavailable with HLA matched donor or related haploidentical donor

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 1-year LFS
timeFrame: Participants will be followed for an expected average of 1 years
Secondary outcomes:
measure: 1-year OS
timeFrame: Participants will be followed for an expected average of 1 years
measure: 1-year TRM
timeFrame: Participants will be followed for an expected average of 1 years
Other outcomes:
measure: Adverse event
timeFrame: Participants will be followed for an expected average of 1 years
measure: Engraftment rate
timeFrame: Participants will be followed for an expected average of 1 years
Locations:
city: Beijing
country: China
facility: Deparment of Hematology, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiaojun Huang, Prof.
role: PRINCIPAL_INVESTIGATOR
References: