Ruxolitinib Phosphate for Chronic Lymphocytic Leukemia Fatigue

Recruiting in Palo Alto (17 mi)

Overseen byZeev Estrov

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial studies how well ruxolitinib phosphate works in reducing fatigue in patients with chronic lymphocytic leukemia. The medication blocks a protein that helps cancer cells grow, which might also help with tiredness and other symptoms. Patients take the medication regularly unless their disease gets worse or they experience severe side effects.

Eligibility Criteria

This trial is for patients with chronic lymphocytic leukemia who experience fatigue, have stable blood counts, and are not in immediate need of CLL treatment. They must understand the study and consent to participate. Pregnant or breastfeeding women, those with recent serious illnesses or infections, and individuals on certain medications are excluded.

Inclusion Criteria

I am able to care for myself and perform daily activities.

I have been diagnosed with CLL but do not require treatment yet.

I experience noticeable symptoms from my condition.

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Exclusion Criteria

I needed blood transfusions due to low blood counts, not because of surgery.

I am not taking any medications that are not allowed in the study, except when approved by the study doctor.

Subjects of childbearing potential who are unwilling to take appropriate precautions (throughout the study from screening, including 30 days after discontinuation of the study drug) to avoid becoming pregnant or fathering a child

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Participant Groups

The trial tests Ruxolitinib Phosphate's effectiveness in reducing fatigue associated with chronic lymphocytic leukemia by blocking a protein called JAK that cancer cells need to grow. It also evaluates changes in lymph node size and leukemia cell counts.

1Treatment groups

Experimental Treatment

Group I: Supportive care (ruxolitinib phosphate)Experimental Treatment2 Interventions

Patients receive ruxolitinib phosphate PO BID (approximately 12 hours apart) for up to 2 years in the absence of disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as Jakafi for: