Clinical trial NCT04686929: Abatacept s.c. for aGVHD Prevention in Haplo-HCT
Official title: The Efficacy and Safety of Subcutaneous Abatacept in the Prevention of Acute Graft-versus-host Disease After Haplo-identical Donor Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Abatacept
Acute-graft-versus-host Disease
Haplo-identical HCT
Prevention
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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 criteria: 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
8. Agree to use effective contraception

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

Primary outcomes:
measure: Incidence of overt aGVHD
timeFrame: 100 days post-HCT
Secondary outcomes:
measure: Incidence of aGVHD
timeFrame: 100 days post-HCT
measure: Incidence of severe aGVHD
timeFrame: 100 days post-HCT
measure: Early transplant-related mortality
timeFrame: 100 days post-HCT
measure: Relapse
timeFrame: 100 days post-HCT
Other outcomes:
measure: Engraft failure
timeFrame: 100 days post-HCT
measure: Blood cell recovery
timeFrame: 100 days post-HCT
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: