Actively Recruiting
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Led by University of Washington · Updated on 2026-04-17
62
Participants Needed
1
Research Sites
360 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 from spreading. Giving venetoclax with CLAG-M may kill more cancer cells.
CONDITIONS
Official Title
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia or high-grade myeloid neoplasm with 10% or more myeloid blasts
- Newly diagnosed patients with adverse risk disease per European LeukemiaNet guidelines
- Relapsed or refractory patients needing salvage therapy with detectable blasts or extramedullary myeloid sarcoma (Phase I only)
- Age 18 years or older
- AST and ALT liver enzymes less than or equal to 3 times upper normal limit
- Bilirubin less than or equal to 1.5 times upper normal limit unless due to Gilbert's syndrome or non-liver cause
- Adequate kidney function with creatinine clearance 30 mL/min or higher
- Left ventricular ejection fraction 45% or higher without heart failure symptoms
- ECOG performance status of 0, 1, or 2
- Treatment-related mortality score less than 13.1
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control during and for 3 months after treatment
- Ability and willingness to sign informed consent
- White blood cell count less than 25,000/µL before starting treatment; cytoreduction allowed
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia in blast crisis
- Known active central nervous system involvement with leukemia
- Other illnesses likely to limit survival to less than 1 year
- Active uncontrolled systemic infections; chronic hepatitis B or C requiring treatment
- Known allergy to any study drug
- Pregnancy or breastfeeding
- Receiving any other investigational treatment
- HIV positive status
- Unable to stop CYP3A inhibitors before treatment except voriconazole
- Recent steroid therapy for cancer within 7 days before venetoclax
- Recent consumption of grapefruit, Seville oranges, or star fruit within 3 days before venetoclax
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
K
Kim Quach
CONTACT
M
Mary-Beth M. Percival
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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