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.
Treatment: Eltanexor · Venetoclax — 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.
Check if I qualifyExtracted 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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