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

Soochow University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Abatacept; Prevention; Acute-graft-versus-host Disease; Haplo-identical HCT

Treatments: Drug: Abatacept s.c.

Study type: Interventional

Funder types: Other

Identifiers

NCT04686929

SZ9102

Details and patient eligibility

About

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.

Enrollment: 29 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Cohort 1

Experimental group

Description:

The participants in Cohort 1 will receive abatacept s.c

Treatment:

Drug: Abatacept s.c.