Can a new drug combo outperform standard care for a tough blood cancer?
NCT ID NCT07754799
First seen Aug 10, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This trial is testing whether adding the drug venetoclax to different chemotherapy regimens can improve outcomes for people newly diagnosed with acute myeloid leukemia (AML). It compares three experimental combinations against the standard treatment in 320 patients aged 14 and older. The goal is to find the most promising regimen to take forward into a larger study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- venetoclax combined with chemotherapy drugs (daunorubicin, cytarabine, liposome mitoxantrone, azacitidine)
- What this could lead to
- If successful, this trial could identify a more effective initial treatment for acute myeloid leukemia, potentially improving remission rates and survival.
- What could go wrong
- This is a phase II trial, so results are preliminary. The experimental combinations may not prove better than standard care and could carry additional side effects.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Sep 2029
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
-
14 years and older
- 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: * Diagnosis of AML per WHO (2022) or ICC criteria, and MDS/AML as defined by ICC (with bone marrow blast percentage of 10%-20%). * Age ≥14 years, male or female. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Judged by the investigator to be suitable for intensive induction chemotherapy and expected to tolerate the treatment intensity specified in the protocol. * Meet the following laboratory test requirements (assessed within 7 days prior to treatment): 1. Total bilirubin ≤1.5 × upper limit of normal (ULN) for the same age group; 2. AST and ALT ≤2.5 × ULN for the same age group; 3. Serum creatinine \<2 × ULN for the same age group; 4. Cardiac enzymes \<2 × ULN for the same age group; 5. Cardiac ejection fraction determined by echocardiography (ECHO) within the normal range. * Written informed consent must be signed before any study specific procedures are initiated, by the patient themselves or by their immediate family members. If, in consideration of the patient's medical condition, signing by the patient themselves would be detrimental to their treatment, the informed consent may be signed by the legally authorized representative or the patient's immediate family members. Exclusion Criteria: * Acute promyelocytic leukemia with PML-RARA fusion gene. * Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene. * Acute myeloid leukemia with BCR-ABL fusion gene. * Presence of FLT3 mutation (these patients are recommended to be enrolled in clinical trials of FLT3 inhibitors). * Patients who have previously received induction chemotherapy (however, cytoreductive therapy such as hydroxyurea is permitted). * Concurrent malignancy of other organs that requires treatment. * Active cardiac disease, defined as one or more of the following: 1. History of uncontrolled or symptomatic angina pectoris; 2. Myocardial infarction within 6 months prior to study enrollment; 3. History of arrhythmia requiring medication or with clinically significant symptoms; 4. Uncontrolled or symptomatic congestive heart failure (\> NYHA class 2). * Serious infectious diseases (e.g., active tuberculosis, pulmonary aspergillosis). * Patients deemed unsuitable for enrollment by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia (AML) 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 a liposomal drug combo improve AML treatment for older adults?
- Can a CDK8/CDK19 blocker help when leukemia and MDS return?
- Can an Anti-Inflammation drug make AML chemotherapy work better?
- Can a new drug trio overcome venetoclax resistance in leukemia?
- Can engineered cells beat relapsed blood cancers?
- Can a new pill outsmart resistant leukemia?