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OncoMatch/Clinical Trials/NCT06399640

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

Is NCT06399640 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Eltanexor and Venetoclax for relapsed myelodysplastic syndrome.

Phase 1RecruitingVanderbilt-Ingram Cancer CenterNCT06399640Data as of May 2026

Treatment: Eltanexor · VenetoclaxThis 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.

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Extracted eligibility criteria

Cancer type

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: DNA methyltransferase inhibitor — MDS

prior DNA methyltransferase inhibitor (DNMTi) treatment and progression after 2 cycles or stable disease after 4 cycles

Must have received: any anti-leukemia therapy — AML

relapsed or refractory following >= 1 line(s) of therapy

Cannot have received: SINE compound or other XPO1 inhibitor

Prior treatment with SINE compounds or other inhibitors of XPO1

Cannot have received: allogeneic hematopoietic stem cell transplant or other cellular therapy product

Exception: allowed if >3 months since transplant

History of allogeneic hematopoietic stem cell transplant (HCT), or other cellular therapy product, within 3 months

Cannot have received: radiation therapy

Exception: allowed if >3 weeks since therapy

Radiation therapy or major surgery within 3 weeks

Cannot have received: major surgery

Exception: allowed if >3 weeks since surgery

Radiation therapy or major surgery within 3 weeks

Cannot have received: anticancer therapy, including investigational agents

Exception: allowed if >2 weeks or >5 half-lives of drug, whichever is shorter, prior to C1D1; hydroxyurea permitted

Anticancer therapy, including investigational agents <= 2 weeks or <= 5 half-lives of the drug, whichever is shorter, prior to C1D1. (Use of hydroxyurea is permitted).

Lab requirements

Kidney function

Calculated creatinine clearance > 50 ml/min (per the Cockroft-Gault formula)

Liver function

ALT(SGPT) and/or AST (SGOT) <= 3x ULN; Direct bilirubin <= 1.5 x ULN; or Total bilirubin <= 2.5x ULN (known Gilbert's Syndrome as cause of elevated bilirubin is allowed)

ALT(SGPT) and/or AST (SGOT) <= 3x upper limit of normal (ULN); Direct bilirubin <= 1.5 x ULN; or Total bilirubin <= 2.5x ULN (known Gilbert's Syndrome as cause of elevated bilirubin is allowed); Calculated creatinine clearance > 50 ml/min (per the Cockroft-Gault formula).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Vanderbilt University/Ingram Cancer Center · Nashville, Tennessee

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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