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

NCT ID: NCT04686929

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-12-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cohort 1

The participants in Cohort 1 will receive abatacept s.c

Group Type EXPERIMENTAL

Abatacept s.c.

Intervention Type DRUG

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

Interventions

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Abatacept s.c.

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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CHEN Jia

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jia Chen, M.D.

Role: CONTACT

Phone: +86 512 6778 1856

Email: [email protected]

Xiang Zhang

Role: CONTACT

Phone: +86 512 6778 1850

Email: [email protected]

Facility Contacts

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Jia Chen, M.D.

Role: primary

Other Identifiers

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SZ9102

Identifier Type: -

Identifier Source: org_study_id