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Eltanexor + Venetoclax for Myelodysplastic Syndrome and Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Somedeb Ball, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >/= 18 years at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF; and must be able to meet all study requirements

For Myelodysplastic Syndrome (MDS): Morphologically confirmed diagnosis of MDS with increased blasts (>/= 5%), with a prior DNA methyltransferase inhibitor (DNMTi) treatment and progression after 2 cycles or stable disease after 4 cycles

Must not have

Women of childbearing age or potential must have negative pregnancy test and must not be actively breastfeeding to enroll on the study

Radiation therapy or major surgery within 3 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the combination of eltanexor and venetoclax for patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that

Who is the study for?

This trial is for patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that has returned after treatment or hasn't responded to past treatments. Participants must meet specific health criteria not detailed here.

What is being tested?

The trial is testing the safety and optimal doses of eltanexor combined with venetoclax in treating relapsed or refractory MDS/AML. Eltanexor aims to kill cancer cells by trapping certain proteins, while Venetoclax targets a protein essential for cancer cell survival.

What are the potential side effects?

Potential side effects may include but are not limited to: fatigue, nausea, diarrhea, low blood counts leading to increased infection risk, bleeding complications, and potential liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and can sign the consent form and meet all study needs.

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My MDS has worsened or not improved after treatment with a specific medication.

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My AML has returned or didn't respond after at least one treatment.

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I am able to care for myself and perform daily activities.

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My liver and kidney functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding and can prove it with a test.

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I have not had radiation or major surgery in the last 3 weeks.

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I have leukemia that has spread to my brain.

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I haven't taken any cancer drugs or participated in other cancer studies within the last 2 weeks.

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I have not taken SINE compounds or drugs that inhibit XPO1 before.

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I had a stem cell transplant or similar therapy within the last 3 months.

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I am currently on or recently stopped medication for GVHD.

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I cannot swallow pills.

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I have not had another type of cancer in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biologically effective dose (BED) of eltanexor in combination with venetoclax

Incidence of adverse events

Secondary study objectives

Complete remission

Duration of response

Overall response rate

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Eltanexor + VenetoclaxExperimental Treatment4 Interventions

Participants receive eltanexor PO QD for 5 days per week for 14, 21, or 28 days every cycle, and venetoclax PO QD on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Participants undergo bone marrow aspiration and biopsy and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration and Biopsy

2016

Completed Phase 1

~40

Biospecimen Collection

2004

Completed Phase 3

~2020