Study on Eltanexor (KPT-8602) and Inqovi for High-Risk Myelodysplastic Syndromes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05918055

Provider View

This clinical trial is testing a new combination of drugs, Eltanexor (KPT-8602) and Inqovi, to see if they can help treat high-risk myelodysplastic syndromes (MDS), a condition affecting blood cell production in the bone marrow.

Patient Parameters

Program Overview

Myelodysplastic syndromes (MDS) are diseases that affect the bone marrow and can lead to low blood cell counts and even leukemia. People with high-risk MDS have a low survival rate, and better treatments are needed. This study is testing a new drug, Eltanexor (KPT-8602), combined with Inqovi, to see if it can help people with high-risk MDS who did not respond to previous treatments. Participants will take these drugs at home in 28-day cycles and visit the clinic for regular check-ups. The study will last for at least 6 cycles, and participants may continue treatment if their condition improves.

Description

Myelodysplastic syndromes (MDS) are a group of diseases that affect the bone marrow, leading to low blood cell counts and a high risk of developing leukemia. Current treatments, like hypomethylating agents (HMAs), are not always effective, and new therapies are needed. This study is testing a combination of Eltanexor (KPT-8602) and Inqovi to see if they can improve treatment outcomes for people with high-risk MDS.

Participants will take Inqovi tablets once a day for the first 5 days of each 28-day cycle. Eltanexor will be taken on a schedule determined by the researchers. Participants will keep a diary to record their doses and visit the clinic for exams and tests. The study will last for at least 6 cycles, and participants may continue treatment if their condition improves. Follow-up visits will continue for about 8 years to monitor long-term effects.

The study aims to find the best dose of Eltanexor to use with Inqovi and to see how well this combination works in treating high-risk MDS. Participants will be closely monitored for side effects and treatment responses.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years and older with confirmed high-risk myelodysplastic syndromes (MDS) that did not respond to previous treatments.
  • Good overall health with a performance status score of 2 or less, meaning they can carry out light work or are fully active.
  • Adequate organ and bone marrow function as shown by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 6 months after.
  • Men must agree to use contraception or abstain from intercourse during the study and for 6 months after.
  • Willing to stop breastfeeding during the study and for 30 days after the last dose.
  • Any previous cancer treatments must have been completed at least 4 weeks before starting the study, except for Inqovi.
  • Ability to understand and sign a written informed consent document.

Exclusion Criteria

  • Unable to maintain platelet levels with transfusions or have uncontrolled bleeding issues.
  • Severe low white blood cell count with frequent hospitalizations for infections.
  • Recent use of medications that stimulate white blood cell production.
  • Allergic reactions to similar drugs used in the study.
  • Uncontrolled illnesses or conditions that could interfere with the study.
  • Serious heart conditions like heart failure or unstable chest pain.
  • Pregnant or breastfeeding women.
  • Other active cancers requiring treatment within the last 24 months, except for certain skin cancers.
  • Active or uncontrolled infections like Hepatitis B, Hepatitis C, or HIV/AIDS.

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