A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression

Completed · Phase 1/Phase 2

Conditions studied: Graft Vs Host Disease, GVHD

In brief

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 3 arm sequential 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).

Key facts

Study ID

NCT02891603

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

40

Starts

2017-06-08

Expected to finish

2022-04-18

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have an available 8/8 HLA-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft.
• Signed informed consent.
• Acute myeloid leukemia, myelodysplasia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myeloproliferative neoplasms, Hodgkin lymphoma, or non-Hodgkin lymphoma requiring a matched allogeneic hematopoietic stem cell transplantation (HSCT). Acute Leukemia (AML or ALL) must be in complete remission defined as: <5% marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow >20% cellular, and peripheral absolute neutrophil count >1000/uL (platelet recovery is not required). Myelodysplasia (MDS) and chronic myeloid leukemia (CML): Must have <5% marrow blasts. Myeloproliferative neoplasms (MPN): Must have <5% peripheral / marrow blasts. Note: Prior use of a JAK2 inhibitor is allowed up to 4 weeks before day 0 of alloHCT. Hodgkin and non-Hodgkin lymphoma: Must have chemosensitive disease.
• Adequate vital organ function.
• Performance status: Karnofsky Performance Status Score ≥ 80%.
• Donor Eligibility:
• Eligible donors will include healthy sibling, relative or unrelated donors that are matched with the patient at HLA-A, B, C, and DRB1 by high resolution typing as defined by the Collaborative Trials Network.

You may not qualify if…

• Active infection not controlled with appropriate antimicrobial therapy.
• History of HIV, hepatitis B, or active hepatitis C infection.
• Anti-thymocyte globulin, alemtuzumab, bortezomib, or post-transplant cyclophosphamide as part of GVHD prophylaxis.
• Sorror's co-morbidity factors with total score >4.
• Any patient anticipating or scheduled to receive a tyrosine kinase inhibitor, FLT3 inhibitor, or JAK2 inhibitor (outside of this study) post-HCT.
• QTc>450ms per Fridericia's correction.
• Thrombin time (TT), prothrombin time (PT), or partial thromboplastin time (PTT) >2x upper limit of normal (ULN).
• Grade 3 or higher recent (within the past 6 months) or ongoing non-QTc cardiac adverse events/comorbidities.
• Grade 3 or higher recent or ongoing cardiac dysrhythmias, family history of long QT.
• syndrome, or serum potassium <3.0 mEq/L that is persistent and refractory to correction.
• Grade 3 or higher recent or ongoing bleeding events.
• Symptomatic or uncontrolled cardiovascular disease, myocardial infarction or severe/unstable angina within the past 6 months, or New York Heart Association (NYHA) Class III or IV congestive heart failure.

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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