Ruxolitinib for Myelofibrosis

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byGabriela Hobbs, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research study is studying a drug called Ruxolitinib as a possible treatment for Myelofibrosis.

Eligibility Criteria

This trial is for adults aged 18-75 with primary or secondary myelofibrosis, who are either already taking Ruxolitinib or will start it. They must have symptoms like an enlarged spleen and meet certain blood count criteria. Participants should be fit enough for a stem cell transplant from a matched donor and not have severe organ damage, uncontrolled infections, heart failure, other recent cancers (except some skin cancers), or be pregnant.

Inclusion Criteria

I am eligible for or already on ruxolitinib for my enlarged spleen or symptoms, and my spleen has not grown >5 cm since starting treatment.

You are expected to live for at least 3 more months.

I am not on any treatment for myelofibrosis except ruxolitinib.

See 7 more

Exclusion Criteria

You have an allergy or extreme sensitivity to any medication that belongs to the JAK inhibitor family.

My blood or bone marrow had a rapid increase in immature cells before my cell transplant.

I have an infection that is not under control.

See 3 more

Treatment Details

Interventions

Ruxolitinib (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe study tests the drug Ruxolitinib in patients with myelofibrosis before, during, and after they receive a hematopoietic stem cell transplant (HSCT). The goal is to see how well Ruxolitinib works as part of the treatment process for this condition.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Ruxolitinib Not Eligible pre-HSCTExperimental Treatment1 Intervention

* Ruxolitinib will be taken orally at a fixed dose twice every day after transplant * Dosing will be continuous, with a new cycle scheduled to start every 28 days. * There will be no break in dosing between cycles * Ruxolitinib can be administered with or without food.

Group II: Ruxolitinib Eligible pre-HSCTExperimental Treatment1 Intervention

* Ruxolitinib will be taken orally at a fixed dose twice every day * Dosing will be continuous, with a new cycle scheduled to start every 28 days. * There will be no break in dosing between cycles * Ruxolitinib can be administered with or without food.

Ruxolitinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Jakafi for: