Study on Venetoclax and CLAG-M for Treating Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT04797767

Provider View

This clinical trial is testing a combination of drugs, including venetoclax and a chemotherapy regimen called CLAG-M, to find the best dose and see how well it works in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms.

Patient Parameters

Program Overview

The study aims to determine the best dose and side effects of venetoclax when used with a chemotherapy combination called CLAG-M, which includes cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone. Venetoclax may help stop cancer cells from growing by blocking a protein they need to survive. The chemotherapy drugs work in different ways to kill cancer cells or stop them from spreading. The hope is that using venetoclax with CLAG-M will kill more cancer cells.

Description

In this study, patients will receive a combination of drugs to treat their cancer. The treatment includes:

  • Granulocyte colony-stimulating factor given under the skin on days 0-5 if white blood cell count is low.
  • Cladribine, cytarabine, and mitoxantrone given through an IV on specific days.
  • Venetoclax taken by mouth on days 1-14.

This treatment cycle repeats every 28-35 days for up to 2 cycles with mitoxantrone and up to 4 cycles without it, as long as the cancer does not progress and side effects are manageable. Patients will have regular bone marrow and blood tests throughout the study.

After finishing the treatment, patients will have follow-up visits every 3 months for a year to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with acute myeloid leukemia or high-grade myeloid neoplasm with specific characteristics.
  • For Phase I, newly diagnosed patients must have high-risk disease, and relapsed patients must need further treatment.
  • For Phase II, newly diagnosed patients must have high-risk disease.
  • Must be 18 years or older.
  • Liver and kidney function must be within specific limits.
  • Heart function must be adequate.
  • Must be in good overall health with an ECOG score of 2 or less.
  • Women of childbearing potential must test negative for pregnancy and agree to use birth control during and after the study.
  • Must understand and agree to the study requirements.
  • White blood cell count must be below a certain level before starting treatment.

Exclusion Criteria

  • Have specific types of leukemia not included in the study.
  • Have active leukemia in the central nervous system.
  • Have another serious illness with a life expectancy of less than a year.
  • Have an active infection that is not controlled.
  • Have a known allergy to any study drug.
  • Are pregnant or breastfeeding.
  • Are taking other investigational drugs.
  • Are HIV positive.
  • Cannot stop taking certain medications that interact with the study drugs.
  • Have used certain medications or foods that interact with venetoclax shortly before starting the study.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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