Study on Adding Enasidenib to Standard Treatment for Higher-Risk Myelodysplastic Syndrome with IDH2 Mutation

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06577441

Provider View

This clinical trial is testing whether adding the drug enasidenib to the usual treatment of cedazuridine-decitabine can improve outcomes for patients with higher-risk myelodysplastic syndrome (MDS) that has an IDH2 mutation.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with higher-risk myelodysplastic syndrome (MDS) that has a specific genetic mutation called IDH2. The trial compares the standard treatment, which includes two drugs, cedazuridine and decitabine, with a combination of these drugs plus enasidenib. Cedazuridine helps decitabine work better by preventing its breakdown in the body, while decitabine helps the bone marrow produce normal blood cells. Enasidenib is designed to block certain enzymes that cancer cells need to grow. The goal is to see if this combination can more effectively treat patients with this type of MDS.

Description

The main goal of this study is to compare how well the combination of enasidenib with cedazuridine-decitabine works compared to cedazuridine-decitabine alone in achieving complete remission in patients with higher-risk MDS with an IDH2 mutation. Researchers will also look at how long patients live without the disease getting worse, overall survival rates, and any side effects from the treatments.

Patients will be randomly assigned to one of two groups. In Group A, patients will take cedazuridine-decitabine by mouth for five days in each 28-day cycle. If they do not achieve a complete response after six cycles, they may switch to Group B. In Group B, patients will take both cedazuridine-decitabine and enasidenib by mouth, with enasidenib taken daily throughout the cycle.

Throughout the study, patients will have regular bone marrow tests and may provide additional samples for research. After finishing the treatment, patients will be followed up every six months for up to five years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be part of the MyeloMATCH program and assigned to this study.
  • Must not have received prior treatment for acute myeloid leukemia (AML) or MDS, except for certain allowed medications.
  • Must have a confirmed diagnosis of MDS with a specific risk score and an IDH2 mutation.
  • Must not have been treated with certain DNA-targeting drugs before.
  • Must be 18 years or older.
  • Must have a performance status that allows for daily activities with some restrictions.
  • Must have acceptable liver and kidney function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Patients with other cancers may participate if it does not interfere with this study.
  • Patients with controlled HIV, hepatitis B, or cured hepatitis C are eligible.
  • Patients in Group A who do not achieve a complete response after six cycles may be eligible to switch to Group B.

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