Could a shorter treatment be just as good for AML in the elderly?
NCT ID NCT07407660
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a shorter course of the drug venetoclax (combined with azacitidine) works as well as the standard longer course for older or frail patients with acute myeloid leukemia (AML). The researchers will check bone marrow on day 14 to decide if the drug can be stopped early. The trial plans to enroll 250 participants and compare how many achieve remission within two cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- venetoclax and azacitidine
- What this could lead to
- If successful, this could lead to a shorter, less toxic treatment option for elderly or frail patients with acute myeloid leukemia, potentially reducing side effects while maintaining effectiveness.
- What could go wrong
- This is a phase 3 trial, but it has not yet started recruiting. The shortened course may not be as effective as the standard regimen, and there is a risk of disease progression or relapse.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Feb 2026
An estimate. Start dates often move.
- Expected to finish
-
Feb 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with newly diagnosed acute myeloid leukemia who meet the WHO 2022 criteria. 2. Meeting one of the following conditions: 1. Aged ≥ 60 years; 2. aged ≥ 18 years and \< 60 years, with one or more of the following comorbidities that render the subject unsuitable for intensive induction therapy: * Complicated with congestive heart failure, or left ventricular ejection fraction ≤ 50%, or a history of chronic stable angina pectoris; * A history of pulmonary disease, with carbon monoxide diffusing capacity of the lung (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%; * Creatinine clearance rate \< 45 mL/min (calculated by the \*\*Cockcroft-Gault formula\*\*); * Total bilirubin \> 1.5 × upper limit of normal; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≥ 2; * Any other comorbidities judged by the investigator to contraindicate intensive induction therapy. 3. 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. 4. Completed risk stratification assessment per the ELN 2022 criteria. 5. Signed the informed consent form. Exclusion Criteria: 1. Diagnosis of acute promyelocytic leukemia, AML with t(8;21)(q22;q22.1)/ RUNX1::RUNX1T1 translocation, or blast crisis of chronic myeloid leukemia (CML). 2. Prior treatment with venetoclax before the diagnosis of acute myeloid leukemia. 3. A history of allogeneic hematopoietic stem cell transplantation. 4. 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. 5. Presence of acute active infection requiring intravenous systemic therapy. 6. Presence of active malignant tumors requiring antineoplastic treatment. 7. Presence of active autoimmune diseases requiring treatment with prednisone ≥ 15 mg/day or equivalent doses of other glucocorticoids, or any other immunosuppressive agents. 8. 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). 9. Pregnant or lactating female subjects. 10. Subjects judged by the investigator to be unable to comply with the protocol due to uncontrollable medical, psychological, familial, social, or geographic conditions; or those who are unwilling or unable to follow the required procedures of the protocol.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?
- New drug combination targets Hard-to-Treat blood cancers