Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis

Summary

This phase II trial studies how well administering ruxolitinib before, during, and after allogeneic hematopoietic stem cell transplantation works in preventing graft versus host disease and improving transplant outcomes in patients with primary and secondary myelofibrosis. Donor hematopoietic stem cell transplantation (HSCT) is currently the only treatment with proven curative potential for myelofibrosis, however, myelofibrosis patients have a high risk for developing graft versus host disease post-transplant. Graft versus host disease is a condition where the transplanted cells from a donor can attack the body's normal cells. Ruxolitinib, a janus-associated kinase (JAK) inhibitor, is known to decrease inflammatory signals, which may reduce spleen size and decrease symptoms such as night sweats and weight loss. Administering ruxolitinib before, during, and after transplant may decrease the incidence and severity of graft versus host disease, increase survival, and improve quality of life in patients with primary and secondary myelofibrosis.

Conditions

• Primary Myelofibrosis
• Secondary Myelofibrosis

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo HSCT

DRUG

Busulfan

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

DRUG

Melphalan

Given IV

DRUG

Methotrexate

Given IV

DRUG

Mycophenolate Mofetil

Given IV or PO

DRUG

Ruxolitinib

Given PO

DRUG

Tacrolimus

Given IV and PO

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Echocardiography

Undergo echocardiography

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Ultrasound Imaging

Undergo ultrasound imaging

Sponsors & Collaborators

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Rachel B. Salit · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-18

Primary Completion

2026-04-03

Completion

2030-04-23

FDA Drug

Yes

Countries

• United States

Study Locations