To hear about similar clinical trials, please enter your email below

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

Login to your account

Did you forget your password?