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

Prevention Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686929
• Other study ID #: SZ9102
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: December 2022
• Source: The First Affiliated Hospital of Soochow University
• Contact: Jia Chen, M.D.
• Phone: +86 512 6778 1856
• Email: drchenjia[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abatacept
• Acute-graft-versus-host Disease
• Graft vs Host Disease
• Haplo-identical HCT
• Prevention

Intervention

Drug:
• Abatacept s.c.
subcutaneous abatacept: 250mg (d-1) , 125mg (d+5, +14, +21, +28, +35, +42, +49, +56) combined with CsA, MTX, MMF.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Engraft failure	Failed to engraft with donor cells	100 days post-HCT
Other	Blood cell recovery	Neutrophil count recover to 1000/ul and platelet count recover to 20000/ul	100 days post-HCT
Primary	Incidence of overt aGVHD	The incidence of grade II-IV aGVHD post-transplantation	100 days post-HCT
Secondary	Incidence of aGVHD	The incidence of grade I-IV aGVHD post-transplantation	100 days post-HCT
Secondary	Incidence of severe aGVHD	The incidence of grade III-IV aGVHD post-transplantation	100 days post-HCT
Secondary	Early transplant-related mortality	The incidence of early transplant-related mortality	100 days post-HCT
Secondary	Relapse	The incidence of relapse/progression of underlying disease	100 days post-HCT