New chemo cocktail aims to boost survival in elderly leukemia patients
NCT ID NCT06744556
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests two different chemotherapy combinations in adults aged 60-75 with acute myeloid leukemia (AML). One group gets a standard drug combo plus venetoclax (DAV/IAV), while the other gets a newer combo with homoharringtonine (HAV). The goal is to see which regimen leads to better event-free survival and remission rates. The study is active but not recruiting, with 41 participants enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy drugs (homoharringtonine, daunorubicin, idarubicin, cytarabine, venetoclax, azacitidine)
- What this could lead to
- If successful, this could identify a more effective chemotherapy combination for elderly AML patients, potentially improving remission rates and survival.
- What could go wrong
- This is a small, early-phase trial (41 participants) with no results yet. The new regimen may not be better than existing options and could have serious side effects like infection or organ damage.
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
-
41 people
The number who actually took part.
- Started
-
Jan 2025
- Expected to finish
-
Jun 2028
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
-
60 to 75 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. Conforming to the diagnostic criteria of AML or MDS/AML by WHO (2022) or ICC. 2. Age ≥ 60 years and ≤ 75 years, regardless of gender. 3. The performance status assessment of the Eastern Cooperative Oncology Group (ECOG-PS) is 0 - 2. 4. Meeting the requirements of the following laboratory examination indicators (performed within 7 days before treatment): 1\) Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group; 2) AST and ALT ≤ 2.5 times the upper limit of normal for the same age group; 3) Serum creatinine \< 2 times the upper limit of normal for the same age group; 4) Cardiac enzymes \< 2 times the upper limit of normal for the same age group; 5) The cardiac ejection fraction determined by echocardiography (ECHO) \> 50%. The informed consent form must be signed before the initiation of all specific research procedures. It should be signed by the patient himself/herself or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent form should be signed by the legal guardian or an immediate family member of the patient. Exclusion Criteria: 1. Acute promyelocytic leukemia accompanied by the PML-RARA fusion gene 2. Acute myeloid leukemia accompanied by the RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene 3. Acute myeloid leukemia accompanied by the BCR-ABL fusion gene 4. Retreated patients (referring to those who have previously undergone induction chemotherapy but can receive hydroxyurea for cytoreduction). 5. Patients concurrently suffering from malignant tumors in other organs (requiring treatment). 6. Active cardiac diseases, defined as one or more of the following: 1\) Uncontrolled or symptomatic angina pectoris history; 2) Myocardial infarction less than 6 months from the time of enrollment in the study; 3) History of arrhythmias requiring drug treatment or with severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\> NYHA Grade 2); 7\. Severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis). 8\. Those considered ineligible for enrollment by the researcher.
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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.
Contacts and locations
Locations
-
Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020, China
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Other studies related to the condition(s) this trial covers.
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