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A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression
The purpose of this study is to examine a new approach to preventing a serious problem after transplant called graft vs. host disease (abbreviated as GVHD). This is a single-arm, phase I/II, study of Pacritinib with Sirolimus and Tacrolimus (PAC/SIR/TAC) for the prevention of acute GVHD after matched related and unrelated allogeneic hematopoietic cell transplantation (alloHCT).
Phase I: 1) Determine the lowest biologically active dose of pacritinib that is safe and well tolerated when combined with SIR/TAC. Phase II: 2) Determine if PAC/SIR/TAC suppresses STAT3 activity in circulating CD4+ T-cells at day +21, 3) Investigate whether PAC/SIR/TAC reduces the cumulative incidence of grade II-IV acute GVHD by day +100, compared our published rate of 43% with SIR/TAC alone14,15, 4) Investigate the impact of PAC/SIR/TAC on Treg, Th1, and Th17 differentiation after allogeneic HCT, and 5) Determine how PAC/SIR/TAC impacts CD28 and IL-2 receptor signal transduction by measuring S6 (mTOR), H3 ser10 (Aurora kinase), and STAT5 phosphorylation in CD4+ T-cells at days +21 and +100.
Alkeran (Melphalan); FK506 (Tacrolimus); Melphalan (); Pacritinib (); Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus (); Tacrolimus (); busulfan (); fludarabine (Fludarabine phosphate)