CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:1/30/2019
Start Date:January 24, 2019
End Date:January 2024

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The purpose of this study is to examine the safety and efficacy of the addition of BMS-986004
to standard of care Sirolimus (SIR)-based immune suppression.

The approach builds upon extensive evidence supporting the benefit of CD40L blockade in
disrupting key signaling events associated with immune activation. The trial addresses a
pressing clinical need, namely prevention of Graft-Versus-Host Disease (GVHD) after
hematopoietic cell transplantation (HCT) and promotion of donor-recipient immune tolerance.
The safety profile of this anti-CD40L antibody overcomes major prior limitations, and the
planned biologic studies will provide significant mechanistic insight.

Inclusion Criteria:

- Hematologic malignancy or blood disorder requiring allogeneic HCT

- Adequate vital organ function

- Karnofsky Performance Status Score (KPS) ≥ 80%

- Participants must have an available 8/8 HLA-A, -B, -C, and -DRB1 matched-related or
unrelated donor

Exclusion Criteria:

- Active infection not controlled with appropriate antimicrobial therapy

- HIV, hepatitis B or C infection

- HCT-CI (comorbidity index) > 4

- Anti-thymocyte globulin, or cyclophosphamide administered within 14 days before or
planned to receive with HCT conditioning or as part of GVHD prophylaxis in the 14 days
after HCT
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Farhad Khimani, MD
Phone: 813-745-1537
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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mi
from
Tampa, FL
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