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

NCT05921318 | Recruiting DMC

• 1 other identifier: Highly HLA mismatched HSCT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy; Stem Cell Transplant Complications

Keywords

allogenetic hematopoietic stem cell transplant; HLA locus; Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• 1-year LFS

  defined as disease relapse, disease progression or death (whichever occurs first) within 1 year from the day the patient receives transplantation.

  Participants will be followed for an expected average of 1 years

Secondary Outcomes (2)

• 1-year OS

  Participants will be followed for an expected average of 1 years

• 1-year TRM

  Participants will be followed for an expected average of 1 years

Other Outcomes (2)

• Adverse event

  Participants will be followed for an expected average of 1 years

• Engraftment rate

  Participants will be followed for an expected average of 1 years

Study Arms (1)

more than 5/10 HLA-mismatched allo-HSCT

more than 5/10 HLA-mismatched allo-HSCT

Combination Product: Beijing protocol

Interventions

Beijing protocol COMBINATION_PRODUCT

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).

more than 5/10 HLA-mismatched allo-HSCT

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with hematologic malignancy，unavailable with HLA matched donor or related haploidentical donor

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Deparment of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xiaojun Huang, Prof.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Wang, Prof.

CONTACT

13552647384; ywyw3172@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director, hematology department,Peking University People's Hospital

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 27, 2023
• Study Start: June 1, 2023
• Primary Completion: May 31, 2024
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

CN (1)