Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

This phase I/II trial finds the best dose, side effects and how well giving venetoclax in combination with cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone (CLAG-M) in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them fr

Trial Details

NCT ID
NCT04797767
Phase
PHASE1 / PHASE2
Sponsor
University of Washington
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Cladribine
  • Cytarabine
  • Mitoxantrone
  • Recombinant Granulocyte Colony-Stimulating Factor
  • Venetoclax
  • Bone Marrow Aspiration
Locations (sample)
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Diagnosis of acute myeloid leukemia (per the World Health Organization \[WHO\] 2016 classification) or high-grade myeloid neoplasm (\>= 10% myeloid…
  • Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2017 guidelines
  • Relapsed/refractory patients presenting for trial entry must require first or subsequent salvage therapy and have detectable blasts in peripheral b…
  • These patients are only allowed in the phase 1 portion of the trial

For full eligibility, visit ClinicalTrials.gov.

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