OncoMatch/Clinical Trials/NCT06014489
A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML
Official title: A Single Arm Phase II Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine (sc) in Adult Patients With Newly Diagnosed Acute Myeloid Leukaemia (AML) Who Are Not Considered Candidates for Intensive Treatment Regimens
Is NCT06014489 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including azacitidine and Venetoclax for aml, adult.
Treatment: azacitidine · Venetoclax · Cobicistat — The treatment of older unfit patients with acute myeloid leukemia (AML) is challenging. The hypomethylating agents (HMA) azacitidine and decitabine have relatively mild side effects and have proven to be feasible for the treatment of older patients and patients with co-morbidities. Currently, venetoclax added to an HMA agent is the new standard of treatment. Since this new standard comes with a substantial societal financial burden, there is a rational to optimize the venetoclax dosing schedule. The CYP3A4 inhibitor cobicistat (COBI) can be used to increase venetoclax exposure, thereby allowing to reduce the dose of venetoclax and thus costs substantially.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Acute Myeloid Leukemia
Performance status
WHO 0–2
Prior therapy
Cannot have received: anti-leukemic therapy for AML or MDS
Exception: erythropoiesis stimulating agents (ESAs) and hydroxyurea allowed
Patients previously treated for AML or MDS (any anti-leukemic therapy including investigational agents; excluding: 1) erythropoiesis stimulating agents (ESAs); 2) hydroxyurea (previous treatment with hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis).
Lab requirements
Blood counts
Leukocytes < 30 x10^9/L
Kidney function
creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.
Liver function
Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert's syndrome. Alanine transaminase (ALT) ≤ 3 x ULN, unless considered AML-related.
Cardiac function
No myocardial infarction within the last 3 months, left ventricular ejection fraction ≥ 40%, no unstable angina, no NYHA grade IV congestive heart failure, no unstable cardiac arrhythmias.
Leukocytes < 30 x109/L. Adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection. Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert's syndrome. Alanine transaminase (ALT) ≤ 3 x ULN, unless considered AML-related. Cardiac dysfunction as defined by: Myocardial infarction within the last 3 months of study entry, or Reduced left ventricular function with an ejection fraction < 40% as measured by MUGA scan or echocardiogram, or Unstable angina or New York Heart Association (NYHA) grade IV congestive heart failure, or Unstable cardiac arrhythmias.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06014489 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages