Venetoclax with Chemotherapy for Newly Diagnosed AML
This study is testing a new combination of medicines for people with newly diagnosed acute monocytic leukemia (AML) and AML with specific genetic changes (active signaling mutated AML). You would receive venetoclax, a drug that blocks a protein cancer cells need to survive, along with chemotherapy drugs called cladribine, cytarabine, and azacitidine. Researchers want to see how well this combination works to put the cancer into remission (composite complete remission rate). The study plans to enroll 40 adults aged 18 and older. To join, you must be able to understand the study and provide informed consent. The study is currently unclear regarding its recruitment status.
- Study design
- This is an interventional study with a planned enrollment of 40 participants. It is testing a specific treatment regimen, but the phase is not specified.
- What's involved
- You would undergo blood sample collection, bone marrow aspirations, and biopsies. You would receive cladribine and azacitidine intravenously (IV) or subcutaneously (SC), and venetoclax orally.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, composite complete remission, is measured from the start of treatment to post-induction disease assessment (Cycle 1 Day 21 or Cycle 2 Day 21).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06504459
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
Recruiting
PHASE2Ages 18+InterventionalTreatmentOHSU Knight Cancer InstituteInvestigator-initiated
~40 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:AzacitidineBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyCladribineCytarabine
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite complete remission (CRc) rate
Measured over At start of treatment to post-induction disease assessment (Cycle 1 Day 21 or Cycle 2 Day 21. Each cycle is 28 days)
Conditions
Where it's being run
2 sites across 2 statesFlorida1
Oregon1
Study leadership
- Curtis A Lachowiez · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
Severe pulmonary disorder (e.g., diffuse capacity of the lung for carbon monoxide \[DLCO\] ≤ 65% or forced expiratory volume in 1 second \[FEV1\] ≤ 65%)
Creatinine clearance \< 45 ml/min (calculated by the Cockcroft-Gault equation)
Hepatic disorder with total bilirubin \> 1.5 x upper limit of normal (ULN)
Any other comorbidity that the treating physician judges to be incompatible with IC
If ≥ 75 yrs of age, the following organ function values must be met and ECOG must be 0 to 2 at screening:
Creatinine clearance (calculated with the Cockcroft-Gault equation) ≥ 30 ml/min
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Unless due to leukemic infiltration)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x ULN (Unless due to leukemic infiltration) (With the exception of documented Gilbert's syndrome or similar conditions. Liver function testing (LFT) and timepoints may be added, as clinically indicated, in such cases)
Note: In cases of confirmed leukemic organ involvement, exceptions may be made
Willing and able to provide bone marrow (BM) samples, including BM samples for research use only analysis
Willing and able to accept supportive and prophylactic care for hematologic toxicities, infection, and immediate sequalae
Willingness to adhere to (a) study schedule of activities; (b) requirements for bio samples collections; and (b) lifestyle restrictions while on-treatment
Negative urine pregnancy test at screening and within 24 hours of cycle 1 day 1 (C1D1) for persons of childbearing potential (PCBP). Serum pregnancy testing will be used for confirmation in cases of equivocal results. Pregnancy is exclusionary because the agents used in this study have the potential for teratogenic or abortifacient effects
Willingness to comply with study requirements for contraception within the specified timeframe, as follows:
Sperm producing participants who are active with PCBP must use approved contraception from C1D1 to 30 days, 3 months, or 6 months, after the last dose of venetoclax (30 days), azacitidine (3 months), cladribine (6 months), or cytarabine (6 months), whichever is later in time
PCBP who are sexually active with sperm-producing persons must use contraception from C1D1 to 30 days after the last dose of venetoclax or to 6 months after the last dose of azacitidine, cladribine, or cytarabine, whichever is later in time
Exclusion
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
Use of drugs with documented drug-drug interaction toxicities with the study drugs
Strong or moderate CYP3A4 inducers or inhibitors within 2 days or 3 half lives whichever is longer, prior to C1D1 are exclusionary. Dose adjustments and other modifications may be considered if the wash-out period has not been met, with the approval of the investigator and the research pharmacy
Uncontrolled infection. Participants with controlled infection must be afebrile and hemodynamically stable for at least 72 hours prior to C1D1 and must be amenable to alternate treatment if current treatment will interact with investigational regimen
Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). Enrollment of individuals with evidence of chronic HBV or HCV infection will be considered on a case-by-case basis by the principal investigator
Individuals with serology positive for human immunodeficiency virus (HIV) and under active treatment with highly active antiretroviral therapy (HAART) (or another therapy that may interfere with metabolism of study agents)
Pregnancy at enrollment or unwillingness to stop breastfeeding. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding be discontinued from start of treatment until 1 week after the final dose of any study drug
Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, unstable cardiac or pulmonary function or acute insufficiency (e.g., symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia), or psychiatric illness or social situation that could limit compliance with study requirements
What this trial measures
- Composite complete remission (CRc) rateAt start of treatment to post-induction disease assessment (Cycle 1 Day 21 or Cycle 2 Day 21. Each cycle is 28 days)
CRc is defined as achievement of complete remission (CR), CR with partial hematologic recovery (CRh) or CR with incomplete blood count recovery (CRi) after induction (or re-induction). The CRc rate will be computed on the safety set and presented with a point-estimate and exact binomial 95% confidence interval (CI). CRc will also be modeled with univariable logistic regressions, applied to the efficacy set, to determine if any baseline patient or disease feature is correlated with clinical response.