An observational study in Hematologic Malignancy and Stem Cell Transplant Complications, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by Peking University People's Hospital · Observational
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 20 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.
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Patient with hematologic malignancy，unavailable with HLA matched donor or related haploidentical donor
Exclusion Criteria:
more than 5/10 HLA-mismatched allo-HSCT
Combination Product: Beijing 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).
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
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
Adverse event
The incidence rate of acute GVHD, chronic GVHD, CMV activation, EBV activation after transplantation
Time frame: Participants will be followed for an expected average of 1 years
Engraftment rate
The success rate of engraftment after transplantation
Time frame: Participants will be followed for an expected average of 1 years
Plan to share: Undecided
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Peking University People's Hospital