Study on Enasidenib for Treating Anemia in Patients with Lower Risk Myelodysplastic Syndrome or Non-Proliferative Chronic Myelomonocytic Leukemia Without IDH2 Mutation

Sponsor: Stanford University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05282459

Provider View

This clinical trial is testing the safety and effectiveness of enasidenib in improving anemia and reducing the need for blood transfusions in patients with certain blood disorders that do not have an IDH2 mutation.

Patient Parameters

Program Overview

The purpose of this study is to see if enasidenib can safely and effectively improve anemia and reduce the need for blood transfusions in patients with lower risk myelodysplastic syndrome (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML) who do not have a mutation in the IDH2 gene. The study will also look at whether enasidenib can help increase platelet production and understand how it works to boost the body's natural production of red blood cells.

Description

The main goal of this study is to find out if enasidenib can help improve anemia and reduce the need for red blood cell transfusions in patients with certain blood disorders. Researchers will also evaluate how well patients tolerate the treatment, its safety, and how long the benefits last. They will look for specific lab markers that might indicate how well the treatment is working.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with lower risk myelodysplastic syndrome (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML) without an IDH2 mutation.
  • No treatment with certain disease-modifying therapies within 2 months before starting the study.
  • Age 18 or older.
  • Able to perform daily activities with some limitations (ECOG score of 3 or less).
  • Tested negative for IDH2 mutation.
  • Experiencing symptoms of anemia, such as low hemoglobin levels and symptoms like shortness of breath, fatigue, or chest pain.
  • Willing to follow all study procedures and available for the study duration.
  • Able to take oral medication and follow the medication schedule.
  • Women of childbearing potential must agree to use effective birth control or abstain from heterosexual contact during the study and for 30 days after the last dose.
  • Men must agree to use condoms during the study.
  • Have adequate liver and kidney function based on specific blood tests.
  • Able to understand and willing to sign the informed consent form.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.

Exclusion Criteria

  • Using other medications that stimulate red blood cell production within 30 days before the study.
  • Life expectancy of less than 3 months.
  • Severe heart disease or recent heart attack.
  • Have an IDH2 mutation.
  • Pregnant or breastfeeding.
  • Have uncontrolled infections.
  • Have HIV or active hepatitis B or C infections.
  • Have other causes of anemia, such as vitamin deficiencies or gastrointestinal bleeding, unless these can be corrected.
  • Any medical condition that might interfere with the study or its results.
  • Pregnant or breastfeeding.

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