Study on Cobimetinib for Newly Diagnosed or Previously Treated CMML Patients with RAS Pathway Mutations

Sponsor: University of Utah

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04409639

Provider View

This clinical trial is testing the effectiveness of the drug cobimetinib in patients with chronic myelomonocytic leukemia (CMML) who have specific genetic mutations. The study involves taking cobimetinib daily in 28-day cycles, with three weeks on the drug followed by a one-week break.

Patient Parameters

Program Overview

This study is designed to test how well the drug cobimetinib works in treating patients with chronic myelomonocytic leukemia (CMML) that has specific genetic mutations in the RAS pathway. Patients will take cobimetinib daily for three weeks, followed by a one-week break, in 28-day cycles. The treatment will continue until certain criteria for stopping are met.

Description

The trial is open to patients with CMML who have specific genetic mutations in the RAS pathway. It is divided into two groups: one for newly diagnosed patients and another for those who have not responded to previous treatments. The study uses a specific design to determine how many patients respond to the treatment.

Participants will take cobimetinib daily in 28-day cycles, with three weeks on the drug followed by a one-week break. The treatment will continue until the patient no longer benefits from it or experiences unacceptable side effects. The study aims to see if cobimetinib can effectively treat CMML with RAS pathway mutations.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Diagnosed with chronic myelomonocytic leukemia (CMML) with specific genetic mutations in the RAS pathway.
  • Good overall health with an ECOG performance status of 3 or lower.
  • Adequate liver and kidney function based on specific blood tests.
  • Heart function of 50% or higher as measured by an echocardiogram.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Willing to provide informed consent and follow study requirements.

Exclusion Criteria

  • Previous treatment with experimental MEK inhibitors for CMML.
  • Significant heart problems or abnormal heart rhythms.
  • Evidence of leukemia in the central nervous system.
  • Recent major surgery within the last four weeks.
  • History of certain lung or eye conditions.
  • Muscle disorders with high CPK levels.
  • Significant digestive issues affecting medication absorption.
  • Pregnant or breastfeeding women.
  • Use of certain medications that interact with cobimetinib.
  • Recent diagnosis of another cancer, except for certain skin cancers or low-risk prostate cancer.
  • Active infections like tuberculosis, hepatitis B, or hepatitis C.
  • Known HIV infection with detectable viral load.
  • Severe allergy to cobimetinib or its components.
  • Any condition that affects understanding or following the study protocol.

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