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Clinical Trial 19305

Cancer Type: Malignant Hematology
Study Type: Prevention
NCT#: NCT03605927

Phase: Phase I
Principal Investigator: Khimani, Farhad

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

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

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.

Objective

Primary objective: 1. Determine if anti-CD40L antibody therapy in combination with standard sirolimus-based immune suppression prophylaxis significantly reduces the cumulative incidence of grade II-IV acute GVHD after HCT. Secondary objectives: 1. Determine if anti-CD40L antibody therapy will promote development of donor-recipient immune tolerance, as measured by reduced incidence of chronic GVHD, and successful liberation from immune suppression after HCT. 2. Examine safety of anti-CD40L antibody therapy, as measured by comprehensive study of toxicity and mortality outcomes after HCT. 3. Investigate how anti-CD40L antibody therapy impacts markers of immune activation.

Treatments

Therapies

Bone Marrow Transplant; Immunotherapy

Medications

BMS-986004 (); FK506 (Tacrolimus); Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus (); Tacrolimus ()

Inclusion Criteria

  • Hematologic malignancy or blood disorder requiring allogeneic HCT
  • Adequate vital organ function
  • Karnofsky Performance Status Score (KPS) greater than or equal to 80%
  • Participants must have an available 8/8 HLA-A, -B, -C, and -DRB1 matched-related or unrelated donor
  • For females of reproductive potential: use of 2 methods of highly effective contraception
  • For males of reproductive potential: use of condoms

    • 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
  • Pregnancy or nursing
  • Known allergic reactions to components of the study agent
  • Concurrent treatment with another investigational agent
  • 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

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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