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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 16 wordsv6 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 1 to 2v5
  3. Primary completion date: Dec 31, 2025 to Feb 1, 2027 Completion date: Dec 31, 2026 to Oct 1, 2027v4 Show 1 more changeShow less
    • Completion date: Dec 31, 2026 to Oct 1, 2027
  4. Start date changed from estimate of Sep 30, 2024 to Aug 14, 2024v3
  5. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 31, 2026 to Dec 31, 2025 · Start date: Jul 31, 2024 to Sep 30, 2024 · Completion date: Dec 31, 2027 to Dec 31, 2026 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2026 to Dec 31, 2025
    • Start date: Jul 31, 2024 to Sep 30, 2024
    • Completion date: Dec 31, 2027 to Dec 31, 2026
    • Site details revised
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06399640
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: Karyopharm Therapeutics Inc, National Cancer Institute (NCI)
Conditions Relapsed Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome, Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov