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Trial Title:
Beijing Protocol in Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT
NCT ID:
NCT05921318
Condition:
Hematologic Malignancy
Stem Cell Transplant Complications
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Conditions: Keywords:
allogenetic hematopoietic stem cell transplant
HLA locus
Hematologic Malignancy
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Combination Product
Intervention name:
Beijing protocol
Description:
For patients <55 years and HCT-CI≤ 3：Ara-C(4g/m2/day,-9 days),Bu(9.6mg/kg,-8 days to -6
days),Cy(1,800mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10
mg/kg,-5 to -2 days)
For patients ≥ 55 years or HCI-CI>3：Ara-C(2g/m2/day,-10 days to -9 days),Bu(9.6mg/kg,-8
days to -6 days),Flu(30mg/m2/day,-6 days to -2 days),Cy(1,000mg/m2/day,-5 days to -4
days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days).
Arm group label:
more than 5/10 HLA-mismatched allo-HSCT
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.
Criteria for eligibility:
Study pop:
Patient with hematologic malignancy，unavailable with HLA matched donor or related
haploidentical donor
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Deparment of Hematology, Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojun Huang, doctor
Phone:
8601088326666
Email:
xjrm@medmail.com.cn
Investigator:
Last name:
Xiaojun Huang, Dr.
Email:
Principal Investigator
Start date:
June 1, 2023
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05921318
