Study on Ruxolitinib for Treating Chronic Myelomonocytic Leukemia (CMML): Phase 2 Expansion

Inclusion Criteria

• Have a confirmed diagnosis of Chronic Myelomonocytic Leukemia (CMML) based on specific medical guidelines.
• Be 18 years or older.
• Be able to attend all study visits and follow the study requirements.
• Be able to provide bone marrow samples for analysis during the screening process.
• Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
• Women of childbearing potential must agree to use two reliable forms of birth control or abstain from heterosexual intercourse for at least 28 days before, during, and after the study.
• Understand and sign an informed consent form.
• Have a life expectancy of more than 3 months at the time of screening.
• Have symptoms of an enlarged spleen and/or a high symptom score related to Myeloproliferative Neoplasms.

Exclusion Criteria

• Have certain lab abnormalities, such as low platelet count, low neutrophil count, high serum creatinine, or high bilirubin levels.
• Have used chemotherapy or experimental treatments for CMML within 28 days before starting the study drug.
• Have had metastatic cancer in the past 2 years.
• Have a serious medical or psychiatric condition that prevents signing the consent form or poses a risk if participating in the study.
• Be using certain medications like GM-CSF, though short-term use of G-CSF for infections is allowed. Stable doses of erythropoietin or corticosteroids started more than 8 weeks before the study are allowed.
• Have uncontrolled illnesses, such as active infections, heart failure, unstable chest pain, or psychiatric conditions that affect study participation.
• Be pregnant or breastfeeding, as ruxolitinib has not been studied in these conditions.