Study on Pacritinib and Azacitidine for Chronic Myelomonocytic Leukemia (CMML)

Sponsor: Douglas Tremblay

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06159491

Provider View

This clinical trial is testing a combination of the drugs pacritinib and azacitidine in adults with Chronic Myelomonocytic Leukemia (CMML). The study aims to find the best dose and see if this treatment can help patients who are newly diagnosed or have been treated before but not with a JAK inhibitor.

Patient Parameters

Program Overview

This study is exploring a new treatment for Chronic Myelomonocytic Leukemia (CMML) using a combination of pacritinib and azacitidine. The trial is divided into two phases. In the first phase, researchers will test different doses to find the safest and most effective one. In the second phase, they will evaluate how well the treatment works in controlling the disease. Participants will receive pacritinib and azacitidine in cycles, and their health will be closely monitored to assess the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must agree to participate and sign a consent form.
  • Must have a confirmed diagnosis of chronic myelomonocytic leukemia (CMML).
  • Must not have been treated with a JAK inhibitor before.
  • May have had up to one cycle of treatment with a hypomethylating agent (HMA).
  • Must have a specific type of CMML with certain risk factors or high white blood cell count.
  • Must have a life expectancy of at least 24 weeks.
  • Must be in relatively good health with an ECOG performance status of 3 or lower.
  • Women of childbearing potential must use effective birth control during treatment and for 6 months after. Men must use effective birth control during treatment and for 3 months after.
  • Must have adequate organ function based on specific blood tests.
  • Must be able to attend study visits and follow all study requirements.
  • Must understand and agree to the study by signing a consent form.

Exclusion Criteria

  • Currently participating in another study or have recently used an investigational drug or device.
  • Have active Graft Versus Host Disease (GVHD) requiring treatment, except for certain low-dose steroids.
  • Taking certain medications that affect liver enzymes within 14 days before starting the study.
  • Have had other invasive cancers in the last 3 years, except for certain skin, prostate, or cervical cancers.
  • Have a serious infection or have had COVID-19 unless fully recovered.
  • Have a serious medical or psychiatric condition that could interfere with the study.
  • Have uncontrolled HIV.
  • Have had significant bleeding issues recently.
  • Taking medications that increase bleeding risk, except for low-dose aspirin.
  • Have had serious heart conditions recently.
  • Have heart failure or certain heart rhythm issues.
  • Have active hepatitis B or C requiring treatment.
  • Have a family member involved in the study.
  • Have had an organ transplant, except for bone marrow.
  • Are pregnant or breastfeeding.
  • Have gastrointestinal issues that affect drug absorption.

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