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

Phase 1

Recruiting

• Conditions: Abatacept; Haplo-identical HCT; Prevention; Acute-graft-versus-host Disease
• Interventions: Drug: Abatacept s.c.

• Registration Number: NCT04686929
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Study Start: 2021-06-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-17
• Last Update Posted: 2022-12-20
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	Abatacept s.c.	The participants in Cohort 1 will receive abatacept s.c

Primary Outcome Measures

Name	Time	Method
Incidence of overt aGVHD	100 days post-HCT	The incidence of grade II-IV aGVHD post-transplantation

Secondary Outcome Measures

Name	Time	Method
Incidence of severe aGVHD	100 days post-HCT	The incidence of grade III-IV aGVHD post-transplantation
Early transplant-related mortality	100 days post-HCT	The incidence of early transplant-related mortality
Incidence of aGVHD	100 days post-HCT	The incidence of grade I-IV aGVHD post-transplantation
Relapse	100 days post-HCT	The incidence of relapse/progression of underlying disease

Trial Locations

Locations (1)

the First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China