TerminatedPhase 1/2

Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms

Stopped: The study was originally planned to assess four escalating DLs of ruxolitinib (upto 40 mg twice daily), but was closed early due to slow enrollment and changing treatment landscape moving towards less intense approaches.

United States12 participantsStarted 2019-02-20

Plain-language summary

This phase I/II trial studies the best dose of ruxolitinib when given together with CPX-351 and to see how well they work in treating patients with accelerated phase or blast phase myeloproliferative neoplasm. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. CPX-351 is a mixture of 2 chemotherapy drugs (daunorubicin and cytarabine) given for leukemia in small fat-based particles (liposomes) to improve the drug getting into cancer cells. Giving ruxolitinib and CPX-351 may work better in treating patients with secondary acute myeloid leukemia compared to CPX-351 alone.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Participants eligible for this study have either MPN in accelerated phase (AP) or blast phase (BP), defined as: * MPN-AP is defined by 10% to 19% blasts in the peripheral blood or bone marrow * MPN-BP is defined by \>= 20% blasts in the blood or bone marrow * Either MPN-AP or MPN-BP requires a previous diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), primary or secondary myelofibrosis (MF), or MDS/MPN overlap with intermediate-2 or high risk disease according to IPSS as well as progression on or failure to respond to at least one line of therapy * Participants with ET, PV, or MF that have received prior MPN-associated therapy (e.g., hydroxyurea, hypomethylating agents \[azacitidine, decitabine\], anti-platelet therapies \[e.g., aspirin, anagrelide\], as well as JAK2 inhibitor therapy \[e.g., ruxolitinib or other investigational JAK2 inhibitor\]) are eligible. They must discontinue prior to starting therapy; no wash-out is required * Female participants of childbearing potential must agree to use adequate contraception (2 forms of contraception or abstinence) from the screening visit until 30 days following the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should i…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose Limiting Toxicity (DLT) (Phase I)

Timeframe: Day 1 to day 42

Proportion of Participants That Achieve at Least an Acute Leukemia Response-Partial Response (>= ALR-P, Per 2012 Myeloproliferative Neoplasm - Blast Phase [MPN-BP] Criteria) (Phase 2)

Timeframe: Day 1 to end of induction or re-induction cycle (or upon assessment of the bone marrow biopsy performed near the end of these cycles if this occurs later). Cycle length is 28 days.

Trial details

NCT IDNCT03878199

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-27

Results submitted2026-02-26

View on ClinicalTrials.gov More Essential Thrombocythemia trials