Abatacept s.c. for aGVHD Prevention in Haplo-HCT
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 The participants in Cohort 1 will receive a lower dose of abatacept s.c as maintenance |
Drug: Lower dose of abatacept
subcutaneous abatacept: 250mg (d-1) , 125mg (d+5, +14, +21, +28, +35, +42, +49, +56) combined with CsA, MTX, MMF.
|
| Experimental: Cohort 2 The participants in Cohort 2 will receive a higher dose of abatacept s.c as maintenance |
Drug: Higher dose of abatacept
subcutaneous abatacept: 250mg (d-1, +5, +14, +21, +28, +35, +42, +49, +56) combined with CsA, MTX, MMF.
|
Outcome Measures
Primary Outcome Measures
- Incidence of overt aGVHD [100 days post-HCT]
The incidence of grade II-IV aGVHD post-transplantation
Secondary Outcome Measures
- Incidence of aGVHD [100 days post-HCT]
The incidence of grade I-IV aGVHD post-transplantation
- Incidence of severe aGVHD [100 days post-HCT]
The incidence of grade III-IV aGVHD post-transplantation
- Early transplant-related mortality [100 days post-HCT]
The incidence of early transplant-related mortality
- Relapse [100 days post-HCT]
The incidence of relapse/progression of underlying disease
Other Outcome Measures
- Engraft failure [100 days post-HCT]
Failed to engraft with donor cells
- Blood cell recovery [100 days post-HCT]
Neutrophil count recover to 1000/ul and platelet count recover to 20000/ul
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age≧18 years
-
ECOG score 0-2 / Karnofsky score≧80
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haplo-HCT is proposed
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Conditioning with motified Bu/Cy+ATG regimen
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Having the following hematologic malignancies with transplant indications:
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Acute leukemia
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Myelodysplastic syndrome
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Aggressive lymphoma
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Expected survival ≥ 3 months
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Written informed Consent can be acquired
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Agree to use effective contraception
Exclusion Criteria:
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With a history of allo-HCT previously
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Allergic/intolerant to Abatacept
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Contraindications to the use of Abatacept
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HIV infection, or active HBV infection or HCV infection
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Uncontrolled active infection
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Vital organ function intolerated to transplantation
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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
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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
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Any life-threatening disease, medical condition, or organ dysfunction unfit for participants, or may interfere with the absorption or metabolism of Abatacept
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215006 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SZ9102