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Completed

NCT Number: NCT04686929

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abatacept s.c.

Drug

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

Primary outcomes

  1. Incidence of overt aGVHD

    Time frame: 100 days post-HCT

    The incidence of grade II-IV aGVHD post-transplantation

Secondary outcomes

  1. Incidence of aGVHD

    Time frame: 100 days post-HCT

    The incidence of grade I-IV aGVHD post-transplantation

  2. Incidence of severe aGVHD

    Time frame: 100 days post-HCT

    The incidence of grade III-IV aGVHD post-transplantation

  3. Early transplant-related mortality

    Time frame: 100 days post-HCT

    The incidence of early transplant-related mortality

  4. Relapse

    Time frame: 100 days post-HCT

    The incidence of relapse/progression of underlying disease

Other outcomes

  1. Engraft failure

    Time frame: 100 days post-HCT

    Failed to engraft with donor cells

  2. Blood cell recovery

    Time frame: 100 days post-HCT

    Neutrophil count recover to 1000/ul and platelet count recover to 20000/ul

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

The Efficacy and Safety of Subcutaneous Abatacept in the Prevention of Acute Graft-versus-host Disease After Haplo-identical Donor Hematopoietic Cell Transplantation

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Dec 29, 2020
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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