Ruxolitinib + Thalidomide for Myelofibrosis

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byRaajit K Rampal, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to test any good and bad effects of the study drugs called ruxolitinib and thalidomide. Ruxolitinib and thalidomide could shrink the cancer, but it could also cause side effects.

Eligibility Criteria

This trial is for adults with myelofibrosis needing treatment, including those who've had previous treatments or are newly diagnosed with certain risk scores. Participants must be able to take oral meds, have proper organ function, and not be pregnant or breastfeeding. Men and women must use effective birth control. Those already on Ruxolitinib need a stable dose for at least 4 weeks.

Inclusion Criteria

I am 18 years or older.

I can care for myself and am up and about more than 50% of my waking hours.

My organs are functioning well.

+10 more

Exclusion Criteria

I haven't had a blood clot in my veins or lungs in the last 6 months.

I have been treated with Thalidomide and Ruxolitinib together.

I haven't taken cancer drugs other than hydroxyurea or Ruxolitinib recently.

+7 more

Participant Groups

The study is testing the combination of two drugs: Ruxolitinib and Thalidomide, to see if they can shrink myelofibrosis cancer cells effectively. The trial will monitor both the positive outcomes and any adverse side effects from this drug combo.

2Treatment groups

Experimental Treatment

Group I: Cohort B: Ruxolitinib and ThalidomideExperimental Treatment2 Interventions

A cohort expansion, for patients with baseline thrombocytopenia, will enroll 35 additional patients After 3 cycles of ruxolitinib treatment, either prior to study enrollment or through the ruxolitinib run-in phase, patients who meet eligibility criteria will be treated with ruxolitinib and thalidomide orally on days 1-28 of a 28 day cycle. Cycles will be continued until the patient wishes to be removed from the study, unacceptable toxicity develops, disease progression, treating physician recommends removal, or termination of study occurs.

Group II: Cohort A: Ruxolitinib and ThalidomideExperimental Treatment2 Interventions

After 3 cycles of ruxolitinib treatment, either prior to study enrollment or through the ruxolitinib run-in phase, patients who meet eligibility criteria will be treated with ruxolitinib and thalidomide orally on days 1-28 of a 28 day cycle. Cycles will be continued until the patient wishes to be removed from the study, unacceptable toxicity develops, disease progression, treating physician recommends removal, or termination of study occurs.

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

🇺🇸 Approved in United States as Jakafi for: