Status:
TERMINATED
ATG Plus Low-dose PT-Cy for GVHD Prevention
Lead Sponsor:
Peking University People's Hospital
Conditions:
Hematologic Malignancy
Eligibility:
All Genders
12-55 years
Phase:
PHASE3
Brief Summary
During the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-HCT) has been made possible through the T cell-replete (TCR) regimens inclu...
Eligibility Criteria
Inclusion
- Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation;
- Male or female , aged 12-55 years;
- Haploidentical donor transplantation;
- ECOG score ≤3; The basic organ function tests met the following standards;
- 1\) Cardiac ejection index \>55% 2) Creatinine ≤1.5 times the highest normal value (ULN)
Exclusion
- Severe brain, heart, kidney or liver dysfunction;
- Refractory malignant state;
- Patients with other malignant tumors requiring treatment;
- Clinically uncontrolled severe active infection;
- The expected survival time was less than 3 months.
- A history of severe anaphylaxis.
- Pregnant or lactating women;
- Any condition considered by the investigators to be unsuitable for enrollment.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06108739
Start Date
November 1 2023
End Date
December 31 2024
Last Update
June 3 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China