RecruitingPhase 1NCT06399640

Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia

Phase Ib Study of Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

60 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of eltanexor in combination with venetoclax for the treatment of patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Eltanexor works by trapping "tumor suppressing proteins" within the cell, thus causing the cancer cells to die or stop growing. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving eltanexor together with venetoclax may be safe, tolerable and/or effective in treating patients with relapsed or refractory MDS or AML.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — eltanexor and venetoclax — in people with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that has come back or stopped responding to previous treatments. Both are targeted cancer drugs that work by blocking proteins that help cancer cells survive. **You may be eligible if...** - You are 18 or older - You have been diagnosed with MDS (with increased blasts) that progressed after treatment, or AML that has relapsed or is no longer responding to therapy - Your liver and kidney function are within acceptable ranges - You have a moderate or better performance level (able to care for yourself) **You may NOT be eligible if...** - You have received cancer treatment within the past 2 weeks - You have had a stem cell transplant within the past 3 months - You have active, uncontrolled infection - You cannot swallow pills - You have active leukemia in the brain or spine - You are pregnant or breastfeeding - You have had a major heart event (heart attack, bypass surgery) in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEltanexor

Eltanexor will be taken by mouth

DRUGVenetoclax

Venetoclax will be taken by mouth

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT06399640


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