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Clinical Trial 19305

Cancer Type: Malignant Hematology
Interventions:BMS-986004; FK506 (Tacrolimus); Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus; Tacrolimus

Study Type: Prevention
Phase of Study: Phase I/II
Investigators:

  • Farhad Khimani

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

Study Title

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

Summary

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.

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