Ruxolitinib + Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+551 other locations

Overseen byKendra L Sweet

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: SWOG Cancer Research Network

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies how well ruxolitinib phosphate, and bosutnib, dasatinib, imatinib or nilotinib, work in treating patients with chronic myeloid leukemia. Chronic myeloid leukemia cells produce a protein called BCR-ABL. The BCR-ABL protein helps chronic myeloid leukemia cells to grow and divide. Tyrosine kinase inhibitors, such as bosutinib, dasatinib, and nilotinib, stop the BCR-ABL protein from working, which helps to reduce the amount of chronic myeloid leukemia cells in the body. Ruxolitinib is a different type of drug that helps to stop the body from making substances called growth factors. Chronic myeloid leukemia cells need growth factors to grow and divide. The addition of ruxolitinib to the tyrosine kinase inhibitor may or may not help reduce the amount of chronic myeloid leukemia cells in the body.

Eligibility Criteria

This trial is for chronic myeloid leukemia patients who've been on tyrosine kinase inhibitors (TKI) like bosutinib, dasatinib, imatinib or nilotinib for at least a year. They should have stable vital signs and organ function, not be pregnant or breastfeeding, agree to use contraception, and not have HIV with detectable viral loads. Prior cancer is okay if no active treatment is needed.

Inclusion Criteria

My BCR-ABL levels are between 0.0032% and 1.0% as confirmed by a recent test.

I am currently on treatment with specific targeted cancer drugs.

My heart's electrical activity is normal as per my recent EKG.

+20 more

Participant Groups

The study tests adding Ruxolitinib—a drug that blocks growth factors necessary for leukemia cells—to the usual TKI treatments. It's a phase II randomized trial aiming to see if this combination better reduces leukemia cell counts compared to TKI alone.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (ruxolitinib phosphate, dasatinib, nilotinib, imatinib)Experimental Treatment5 Interventions

Patients receive ruxolitinib phosphate PO BID on days 1-90, and bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (bosutinib, dasatinib, nilotinib, imatinib)Active Control5 Interventions

Patients receive bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Bosutinib is already approved in United States for the following indications:

🇺🇸 Approved in United States as Bosulif for:

Treatment of adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy
Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML)
Treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML), newly-diagnosed or resistant or intolerant to prior therapy