Study on the Combination of Ruxolitinib and CPX-351 for Treating Advanced Myeloproliferative Neoplasms

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03878199

Provider View

This clinical trial is testing a new treatment combining ruxolitinib and CPX-351 to find the best dose and see how well it works for patients with advanced myeloproliferative neoplasms, a type of blood cancer. The study aims to determine if this combination can better treat the disease compared to CPX-351 alone.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with advanced myeloproliferative neoplasms, a type of blood cancer that has progressed to an accelerated or blast phase. The treatment combines ruxolitinib, which may block cancer cell growth, with CPX-351, a chemotherapy drug mixture designed to better target cancer cells. The study aims to find the best dose of ruxolitinib when used with CPX-351 and to see if this combination is more effective than CPX-351 alone.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest and most effective dose of ruxolitinib when combined with CPX-351. In Phase II, they will evaluate how well this combination works in treating patients with advanced myeloproliferative neoplasms.

During the study, patients will receive CPX-351 through an IV on specific days and take ruxolitinib orally on other days. If the cancer is still present after initial treatment, patients may receive additional cycles of therapy. Those who respond well to treatment may continue with maintenance therapy using ruxolitinib.

Patients who achieve a significant reduction in cancer cells may be eligible for a stem cell transplant if a suitable donor is available. After completing the study treatment, patients will be monitored regularly to assess their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to sign a consent form.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Diagnosed with advanced myeloproliferative neoplasms, either in accelerated or blast phase.
  • Have a history of specific blood disorders like polycythemia vera, essential thrombocythemia, or myelofibrosis.
  • Women of childbearing potential must use effective contraception during and after the study.
  • Men must agree to use contraception or abstain from intercourse during and after the study.
  • Have adequate heart function and be a candidate for intensive chemotherapy.
  • Willing to take oral medication.
  • Have normal kidney and liver function as indicated by specific blood tests.

Exclusion Criteria

  • Currently participating in another clinical trial.
  • Have isolated myeloid sarcoma or acute promyelocytic leukemia.
  • Have active central nervous system involvement by leukemia.
  • Have unresolved severe side effects from previous cancer treatments.
  • Have uncontrolled infections or other serious medical conditions.
  • Have a known allergy to ruxolitinib, cytarabine, daunorubicin, or similar products.
  • Have a history of certain heart conditions or recent heart attack.
  • Have had high exposure to certain chemotherapy drugs in the past.
  • Must stop taking blood thinners or anti-platelet medications before starting the study.

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