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Clinical Trial 19305

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

Phase: Phase I/II
Prinicipal Investigator: Farhad Khimani

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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

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) ≥ 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
  • Planned Post transplant maintenance therapies such as FLT3 inhibitor, tyrosine kinase inhibitor, JAK inhibitors etc. are not allowed in phase 1 part B and Phase 2 portions of the trial.

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