Status:
UNKNOWN
Abatacept s.c. for aGVHD Prevention in Haplo-HCT
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Abatacept
Acute-graft-versus-host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Acute graft-versus-host disease (aGVHD) is a potentially fatal complication after allogeneic hematopoietic cell transplantation (HCT), particularly for that with a HLA-mismatched donor. Abatacept has ...
Eligibility Criteria
Inclusion
- Age≧18 years
- ECOG score 0-2 / Karnofsky score≧80
- haplo-HCT is proposed
- Conditioning with motified Bu/Cy+ATG regimen
- Having the following hematologic malignancies with transplant indications:
- Acute leukemia
- Myelodysplastic syndrome
- Aggressive lymphoma
- Expected survival ≥ 3 months
- Written informed Consent can be acquired
- Agree to use effective contraception
Exclusion
- With a history of allo-HCT previously
- Allergic/intolerant to Abatacept
- Contraindications to the use of Abatacept
- HIV infection, or active HBV infection or HCV infection
- Uncontrolled active infection
- Vital organ function intolerated to transplantation
- Other malignancies except for the following diseases: malignant tumors that have been cured for at least 3 years without active lesions; adequete treated non-melanoma skin cancer, malignant amygdala, and carcinoma in situ without active lesions
- Evidence of complications or medical conditions that may interfere with research or put the subjects at serious risk, including but not limited to severe cardiovascular disease (e.g. New York Heart Association grade III or IV heart disease, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina) and/or severe lung disease (e.g. history of severe obstructive lung disease and symptomatic bronchospasm)
- Pregnant and lactational women
- Any life-threatening disease, medical condition, or organ dysfunction unfit for participants, or may interfere with the absorption or metabolism of Abatacept
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04686929
Start Date
June 1 2021
End Date
December 30 2023
Last Update
December 20 2022
Active Locations (1)
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1
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006