Shortened Venetoclax Duration Based on Day 14 BM Blasts Versus Standard Therapy in Elderly or Fra… (NCT07407660) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Shortened Venetoclax Duration Based on Day 14 BM Blasts Versus Standard Therapy in Elderly or Frail Patients With AML Patients Treated With Azacitidine Plus Venetoclax
250 participantsStarted 2026-02-01
Plain-language summary
This study aims to compare the efficacy and safety of a shortened treatment course based on the bone marrow blast count on Day 14 versus standard treatment in patients with acute myeloid leukemia treated with venetoclax plus azacitidine.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with newly diagnosed acute myeloid leukemia who meet the WHO 2022 criteria.
. Meeting one of the following conditions:
. Aged ≥ 60 years;
. aged ≥ 18 years and \< 60 years, with one or more of the following comorbidities that render the subject unsuitable for intensive induction therapy:
. Received induction therapy with the azacitidine plus venetoclax regimen (azacitidine for injection: 75 mg/m² subcutaneously on Days 1-7; venetoclax tablets: 100 mg on Day 1, 200 mg on Day 2, and 400 mg once daily starting on Day 3) for 12-14 days. Dose adjustment of venetoclax shall be performed if combined with strong or moderate CYP3A/P-gp inhibitors.
. Completed risk stratification assessment per the ELN 2022 criteria.
. Signed the informed consent form.
Exclusion criteria
. Diagnosis of acute promyelocytic leukemia, AML with t(8;21)(q22;q22.1)/ RUNX1::RUNX1T1 translocation, or blast crisis of chronic myeloid leukemia (CML).
. Prior treatment with venetoclax before the diagnosis of acute myeloid leukemia.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Achievement of CR/CRi within 2 treatment cycles
Timeframe: At the end of Cycle 1 and Cycle 2 (each cycle is 28 days). If CRi, repeat 2 weeks later.
. A history of allogeneic hematopoietic stem cell transplantation.
. Severe hepatic or renal impairment, defined by the presence of any of the following abnormalities: aspartate aminotransferase (AST) \> 2.5 × ULN; alanine aminotransferase (ALT) \> 2.5 × ULN; creatinine clearance rate \< 30 mL/min (calculated by the Cockcroft-Gault formula); or total bilirubin \> 3 × ULN.
. Presence of acute active infection requiring intravenous systemic therapy.
. Presence of active malignant tumors requiring antineoplastic treatment.
. Presence of active autoimmune diseases requiring treatment with prednisone ≥ 15 mg/day or equivalent doses of other glucocorticoids, or any other immunosuppressive agents.
. Inability to swallow tablets, or presence of diseases significantly impairing gastrointestinal function (e.g., malabsorption syndrome, gastrectomy or enterectomy, bariatric surgery, symptomatic inflammatory bowel disease, or partial/complete intestinal obstruction).