CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease (NCT03605927) | Clinical Trial Compass
CompletedPhase 1
CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease
United States45 participantsStarted 2019-02-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Hematologic malignancy or blood disorder requiring allogeneic HCT
* Adequate vital organ function as defined per protocol
* 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 or known history of HIV, hepatitis B or C(all patients will be tested for HIV, hepatitis B and C as part of standard pre-transplant testing, and will be excluded from this trial if positive)
* 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
* Known allergic reactions to components of the study drug
* Concurrent treatment with another investigational drug
* History of thromboembolism, transient ischemic attack, stroke, myocardial infarction within 3 months preceding the transplant, or uncontrolled congestive heart failure or cardiac arrhythmias.
* Post-transplant maintenance therapies such as FLT3 inhibitor, tyrosine kinase inhibitor, JAK inhibitors etc. are not allowed if plan is to initiate such therapies \<90 days post-transplant. Patient will be eligible if plan to initiate maintenance therapy is after day 90 post-transplant.
What they're measuring
1
Incidence of Grade II-IV Acute Graft-versus Host Disease
Timeframe: 1 year post HCT
Trial details
NCT IDNCT03605927
SponsorH. Lee Moffitt Cancer Center and Research Institute