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

Primary Purpose

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

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Abatacept s.c.
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abatacept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort 1

Arm Description

The participants in Cohort 1 will receive abatacept s.c

Outcomes

Primary Outcome Measures

Incidence of overt aGVHD
The incidence of grade II-IV aGVHD post-transplantation

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2020
Last Updated
December 17, 2022
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT04686929
Brief Title
Abatacept s.c. for aGVHD Prevention in Haplo-HCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abatacept, Acute-graft-versus-host Disease, Haplo-identical HCT, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
The participants in Cohort 1 will receive abatacept s.c
Intervention Type
Drug
Intervention Name(s)
Abatacept s.c.
Intervention Description
subcutaneous abatacept: 250mg (d-1) , 125mg (d+5, +14, +21, +28, +35, +42, +49, +56) combined with CsA, MTX, MMF.
Primary Outcome Measure Information:
Title
Incidence of overt aGVHD
Description
The incidence of grade II-IV aGVHD post-transplantation
Time Frame
100 days post-HCT
Secondary Outcome Measure Information:
Title
Incidence of aGVHD
Description
The incidence of grade I-IV aGVHD post-transplantation
Time Frame
100 days post-HCT
Title
Incidence of severe aGVHD
Description
The incidence of grade III-IV aGVHD post-transplantation
Time Frame
100 days post-HCT
Title
Early transplant-related mortality
Description
The incidence of early transplant-related mortality
Time Frame
100 days post-HCT
Title
Relapse
Description
The incidence of relapse/progression of underlying disease
Time Frame
100 days post-HCT
Other Pre-specified Outcome Measures:
Title
Engraft failure
Description
Failed to engraft with donor cells
Time Frame
100 days post-HCT
Title
Blood cell recovery
Description
Neutrophil count recover to 1000/ul and platelet count recover to 20000/ul
Time Frame
100 days post-HCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Acute leukemia Myelodysplastic syndrome 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Chen, M.D.
Phone
+86 512 6778 1856
Email
drchenjia@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang Zhang
Phone
+86 512 6778 1850
Email
lcsy2013@sina.com.cn
Facility Information:
Facility Name
the First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Chen, M.D.
Phone
+86 512 67781856
Email
chenjiasuzhou@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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