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.
Bone Marrow Transplant; Therapy (NOS)
Alkeran (Melphalan); FK506 (Tacrolimus); Melphalan (); Pacritinib (); Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus (); Tacrolimus (); busulfan (); fludarabine (Fludarabine phosphate)
Back to top
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.