Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and active signaling mutated AML. 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. Chemotherapy drugs, such as cladribine, cytarabine and azacitidine, 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 cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML.
Sponsor: OHSU Knight Cancer Institute
You may qualify if…
- ✓ Ability to comprehend the investigational nature of the study and provide informed consent (i.e., participant or legally authorized representative \[LAR\]). Written informed consent must be obtained prior to any study-specific procedures or interventions
- ✓ Sign informed consent for the #4422 Biorepository prior to any study-specific procedures of interventions
- ✓ Eligible AML patients of all races and ethnic groups will be considered for participation, irrespective of gender identity
- ✓ Newly diagnosed, histologically confirmed monocytic AML, as defined by World Health Organization (WHO), or active signaling mutated AML defined as AML with mutation(s) to N/KRAS, FLT3 ITD/TKD, NF1, PTPN11 or CBL
- ✓ Ineligible for standard of care induction therapy using intensive chemotherapy (IC) or unwilling to undergo IC induction therapy. Ineligible for IC is defined as
- ✓ ≥ 75 yrs of age; OR
- ✓ 18-74 yrs of age with one of the following:
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2 at screening
You may not qualify if…
- ✕ Symptomatic central nervous system involvement with AML
- ✕ Prior treatment for AML, with the exception of cytoreduction for proliferative disease (per institutional protocol) with any of the following: Hydroxyurea, hematopoietic growth factors, leukapheresis
- ✕ Another active malignancy within the previous 5 years of C1D1
- ✕ Investigational therapy within 28 days of C1D1, or within 5 half-lives or longer, if known
- ✕ Recent and significant medical interventions, such as major surgery within 28 days or stem cell transplant within 100 days (and without active treatment for graft versus host disease \[GVHD\]) of C1D1. Standard of care procedures for patients with hematologic malignancies, such as biopsies and lumbar punctures, are not exclusionary
- ✕ Hypersensitivity to any of the components of the investigational regimen (i.e., cladribine, cytarabine, venetoclax, azacitidine) or any excipients in the formulations
- ✕ Treatment based on agents targeting or inhibiting BCL-2 (for other, prior indication/malignancy) within the previous 5 years
- ✕ History of dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally
Where it's recruiting
Source: ClinicalTrials.gov · NCT06504459 · last updated 2026-04-13