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

Peking University People's Hospital20 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hematologic Malignancy Stem Cell Transplant Complications

Interventions

Beijing protocolCOMBINATION_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).

Eligibility

Sex: ALLMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Deparment of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

1-year LFS

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

Time frame: Participants will be followed for an expected average of 1 years

Secondary Outcomes

1-year OS

defined as survival rate within 1 year from the day the patient receives transplantation, calculated based on death from any cause.

Time frame: Participants will be followed for an expected average of 1 years

1-year TRM

defined as death from any cause other than disease relapse within 1 year from the day the patient receives transplantation.

Time frame: Participants will be followed for an expected average of 1 years

Central Contacts

Yu Wang, Prof.

CONTACT

13552647384 ywyw3172@sina.com

Data from ClinicalTrials.gov

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