Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes

Summary

This phase II trial tests the effect of adding ruxolitinib to standard graft versus host disease (GVHD) prevention in treating older patients with myelofibrosis (MF) or myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap syndromes before, during, and after a donor (allogeneic) hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. Giving chemotherapy, such as cytoxan and busulfan or fludarabine and melphalan, before a donor transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving standard prevention (prophylaxis) therapies, such as tacrolimus and methotrexate, after the transplant may stop this from happening. Methotrexate, a type of antifolate, is in a class of medications called antimetabolites. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill cancer cells. Tacrolimus is used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Ruxolitinib, a type of Janus-associated kinase (JAK) inhibitor, blocks a protein called JAK, which may help keep abnormal blood cells or cancer cells from growing. It may also lower the body's immune response and prevent the development of GVHD. Giving ruxolitinib before, during and after allogeneic HCT in addition to standard GVHD prophylaxis may be safe, tolerable and effective in preventing GVHD and improving outcomes in older patients with MF or MDS/MPN overlap syndrome.

Conditions

• Myelodysplastic/Myeloproliferative Neoplasm
• Primary Myelofibrosis
• Secondary Myelofibrosis

Interventions

DRUG

Ruxolitinib

Given PO

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Given infusion

DRUG

Busulfan

Given IV

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

DRUG

Fludarabine

Given IV

DRUG

JAK Inhibitor

Given JAK inhibitor

DRUG

Melphalan

Given IV

DRUG

Methotrexate

Given IV

DRUG

Tacrolimus

Given IV or PO

PROCEDURE

Biospecimen Collection

Undergo urine and blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

Sponsors & Collaborators

• Incyte Corporation

  collaborator INDUSTRY

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Rachel Salit, MD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-04

Primary Completion

2030-09-01

Completion

2030-09-01

FDA Drug

Yes

Countries

• United States

Study Locations