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

NCT04686929 | Unknown Phase 1

• 1 other identifier: SZ9102
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of overt aGVHD

  The incidence of grade II-IV aGVHD post-transplantation

  100 days post-HCT

Secondary Outcomes (4)

• Incidence of aGVHD

  100 days post-HCT

• Incidence of severe aGVHD

  100 days post-HCT

• Early transplant-related mortality

  100 days post-HCT

• Relapse

  100 days post-HCT

Other Outcomes (2)

• Engraft failure

  100 days post-HCT

• Blood cell recovery

  100 days post-HCT

Study Arms (1)

Cohort 1

EXPERIMENTAL

The participants in Cohort 1 will receive abatacept s.c

Drug: Abatacept s.c.

Interventions

Abatacept s.c. DRUG

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

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≧18 years
• ECOG score 0-2 / Karnofsky score≧80
• haplo-HCT is proposed
• Conditioning with motified Bu/Cy+ATG regimen
• Having the following hematologic malignancies with transplant indications:
• Acute leukemia
• Myelodysplastic syndrome
• Aggressive lymphoma
• Expected survival ≥ 3 months
• Written informed Consent can be acquired
• Agree to use effective contraception

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Central Study Contacts

Jia Chen, M.D.

CONTACT

+86 512 6778 1856; drchenjia@163.com

Xiang Zhang

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 29, 2020
• Study Start: June 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

CN (1)