RecruitingNCT05921318

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

The Safety and Efficiency of Beijing Protocol in Malignant Hematologic Disease Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT


Sponsor

Peking University People's Hospital

Enrollment

20 participants

Start Date

Jun 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Max Age: 70 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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.

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Interventions

COMBINATION_PRODUCTBeijing protocol

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).


Locations(1)

Deparment of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT05921318


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