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Abatacept s.c. for aGVHD Prevention in Haplo-HCT | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

Abatacept s.c. for aGVHD Prevention in Haplo-HCT

The Efficacy and Safety of Subcutaneous Abatacept in the Prevention of Acute Graft-versus-host Disease After Haplo-identical Donor Hematopoietic Cell Transplantation

NCT04686929•The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

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 been demonstrated as a potent drug to reduce the risk of aGVHD, but the efficacy of subcutaneous form has yet been investigated. This trial is designed to preliminarily determin the efficacy and saftey of subcutaneous abatacept in the prevention of aGVHD after haplo-identical HCT.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age≧18 years
•2. ECOG score 0-2 / Karnofsky score≧80
•3. haplo-HCT is proposed
•4. Conditioning with motified Bu/Cy+ATG regimen
•5. Having the following hematologic malignancies with transplant indications:
•1. Acute leukemia
•2. Myelodysplastic syndrome
•3. Aggressive lymphoma
•6. Expected survival ≥ 3 months
•7. Written informed Consent can be acquired
+1 more criteria

Exclusion Criteria

•1. With a history of allo-HCT previously
•2. Allergic/intolerant to Abatacept
•3. Contraindications to the use of Abatacept
•4. HIV infection, or active HBV infection or HCV infection
•5. Uncontrolled active infection
•6. Vital organ function intolerated to transplantation
•7. 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
•8. 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)
•9. Pregnant and lactational women
•10. Any life-threatening disease, medical condition, or organ dysfunction unfit for participants, or may interfere with the absorption or metabolism of Abatacept

Locations (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

June 1, 2021

Primary Completion Date

June 30, 2023

Completion Date

December 30, 2023

Last Updated

December 20, 2022

Enrollment

ESTIMATED participants

Conditions

AbataceptAcute-graft-versus-host DiseaseHaplo-identical HCTPrevention

Interventions

Abatacept s.c.

DRUG

Contacts

Jia Chen, M.D.

CONTACT

+86 512 6778 1856 drchenjia@163.com

Xiang Zhang

CONTACT

+86 512 6778 1850 lcsy2013@sina.com.cn

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ACTIVE_NOT_RECRUITINGPHASE2

Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease

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COMPLETEDPHASE3

Sitagliptin for Prevention of aGVHD After Alternative Donor Transplation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Abatacept s.c. for aGVHD Prevention in Haplo-HCT

Inclusion Criteria

Exclusion Criteria

FMT in Gut aGVHD Treated

Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease

Sitagliptin for Prevention of aGVHD After Alternative Donor Transplation

Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease

Pharmacological Predictors of Successful Cyclosporine Acute GVHD Prophylaxis in Children Undergoing HSCT

Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT