Abatacept s.c. for aGVHD Prevention in Haplo-HCT | NCT04686929

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

NCT04686929

Sponsor

The First Affiliated Hospital of Soochow University

Status

Completed

Last Update Posted

Jun 11, 2026Actual

Enrollment

29Actual

Phase

Phase 1Phase 2

Conditions

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

Interventions

Abatacept s.c.

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

May 31, 2023Actual

Completion Date

Jan 31, 2026Actual

First Submitted Date

Dec 23, 2020

First Submission Date that Met QC Criteria

Dec 23, 2020

First Posted Date

Dec 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2026

Last Update Posted Date

Jun 11, 2026Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Label	Type	Description	Intervention Names
Cohort 1	Experimental	The participants in Cohort 1 will receive abatacept s.c	Drug: Abatacept s.c.

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of overt aGVHD	The incidence of grade II-IV aGVHD post-transplantation	100 days post-HCT

Secondary Outcomes

Measure	Description	Time Frame
Incidence of aGVHD	The incidence of grade I-IV aGVHD post-transplantation	100 days post-HCT
Incidence of severe aGVHD	The incidence of grade III-IV aGVHD post-transplantation

Other Outcomes

Measure	Description	Time Frame
Engraft failure	Failed to engraft with donor cells	100 days post-HCT
Blood cell recovery	Neutrophil count recover to 1000/ul and platelet count recover to 20000/ul

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
1. Acute leukemia
2. Myelodysplastic syndrome
3. Aggressive lymphoma
Expected survival ≥ 3 months
Written informed Consent can be acquired
Agree to use effective contraception

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided