Pre-Transplant JAK Inhibitor for Myelofibrosis

Recruiting in Palo Alto (17 mi)

Overseen byRachel B. Salit

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Fred Hutchinson Cancer Research Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well giving a JAK inhibitor before a donor stem cell transplant works in treating patients with myelofibrosis that developed without another condition (primary) or evolved from other bone marrow disorders (secondary). JAK inhibitors are a class of drugs that may stop the growth of abnormal cells by blocking an enzyme needed for cell growth. Giving a JAK inhibitor such as ruxolitinib before a donor stem cell transplant may help reduce symptoms of myelofibrosis such as inflammation and enlargement of the spleen, improve the patient's general physical condition, and prevent complications from occurring after the transplant. Infusing healthy stem cells from a donor into the patient may help the patient's bone marrow work normally and make stem cells, red blood cells, white blood cells, and platelets. Giving a JAK inhibitor before a donor stem cell transplant may help improve transplant outcomes in patients with myelofibrosis.

Eligibility Criteria

This trial is for patients with primary or secondary myelofibrosis, a type of bone marrow cancer. Participants should have certain risk levels by DIPSS scores, good physical function (Karnofsky >= 70), adequate kidney and liver function, no severe lung issues, and not be on supplemental oxygen. They must understand the study and consent to participate. Pregnant or breastfeeding individuals, those with HIV or uncontrolled infections, prior transplants are excluded.

Inclusion Criteria

My condition is considered intermediate-1, intermediate-2, or high-risk.

Meeting criteria for 1st phase as above, at time of initiation of JAK inhibitor, including ability to understand and willingness to sign a written informed consent; patients arriving to our institution for transplant and not enrolled in Part 1 may still be enrolled in Part 2 if Part 1 criteria met; these patients will have Part 1 endpoints transcribed from medical records

I have been diagnosed with primary or secondary myelofibrosis according to specific medical guidelines.

+19 more

Exclusion Criteria

I don't have a closely matched donor for a transplant.

I have had a fungal infection in the past 6 months without seeing an infectious disease specialist.

I am HIV positive.

+6 more

Participant Groups

The trial tests if taking a JAK inhibitor drug called ruxolitinib before receiving stem cells from a donor can improve outcomes for myelofibrosis patients. The treatment aims to reduce symptoms like spleen enlargement and help the new stem cells work better in producing healthy blood cells after transplant.

1Treatment groups

Experimental Treatment

Group I: Treatment (ruxolitinib, transplant)Experimental Treatment12 Interventions

Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.

Allogeneic Hematopoietic Stem Cell Transplantation is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Allogeneic Hematopoietic Stem Cell Transplantation for: