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

Who is this study for? Patients with Graft versus Host Disease

What treatments are being studied? Pacritinib+Sirolimus+Tacrolimus

Status: Completed

Location: See all (2) locations...

Intervention Type: Drug, Procedure

Study Type: Interventional

Study Phase: Phase 1/Phase 2

SUMMARY

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).

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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.

Locations

United States

Florida

H. Lee Moffitt Cancer Center and Research Institute

Tampa

Minnesota

University of Minnesota

Minneapolis

Time Frame

Start Date: 2017-06-08

Completion Date: 2022-04-18

Participants

Target number of participants: 40

Treatments

Experimental: Phase 1, Level 1: Pacritinib with Sirolimus and Tacrolimus

After standard of care allogenic hematopoietic cell transplantation, Pacritinib will be added to standard treatment with Sirolimus and Tacrolimus (PAC/SIR/TAC).~100 mg Pacritinib will begin taken by mouth the day of the participant's transplant (Day 0) and will continue until 70 days after the transplant..~Sirolimus will be given the day before transplant and continued daily for at least one year.~Tacrolimus will begin 3 days before transplant and will be given for at least 50 days.

Experimental: Phase 1, Level 2: Pacritinib with Sirolimus and Tacrolimus

After standard of care allogenic hematopoietic cell transplantation, Pacritinib will be added to standard treatment with Sirolimus and Tacrolimus (PAC/SIR/TAC).~100 mg Pacritinib will begin taken by mouth twice daily starting the day of the participant's transplant (Day 0) and continuing until 70 days after the transplant..~Sirolimus will be given the day before transplant and continued daily for at least one year.~Tacrolimus will begin 3 days before transplant and will be given for at least 50 days.

Experimental: Phase 2: Pacritinib with Sirolimus and Tacrolimus

After standard of care allogenic hematopoietic cell transplantation, Pacritinib will be added to standard treatment with Sirolimus and Tacrolimus (PAC/SIR/TAC).~Patients will take Pacritinib at the MTD: 100 mg Pacritinib will begin taken by mouth twice daily starting the day of the participant's transplant (Day 0) and continuing until 70 days after the transplant..~Sirolimus will be given the day before transplant and continued daily for at least one year.~Tacrolimus will begin 3 days before transplant and will be given for at least 50 days.

Related Therapeutic Areas

Graft Versus Host Disease (GvHD)

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

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