New drug combo shows promise in AML fight
NCT ID NCT03214562
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
This study tests whether adding the drug venetoclax to standard chemotherapy can better treat acute myeloid leukemia (AML) that is newly diagnosed or has come back. About 116 adults with AML or high-risk MDS will receive the combination. The goal is to see if the combo improves response rates and controls the disease, though lifelong management may still be needed.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 116 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2017
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 by World Health Organization (WHO) criteria. Patients with high risk myelodysplastic syndrome (MDS) as defined by the presence of \>= 10% blasts are also eligible at the discretion of the principal investigator * Patients older than 65 who are deemed fit to receive intensive chemotherapy by the treating physician will be eligible after discussion with the principal investigator (PI). * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Creatinine clearance \>= 30 mL/min based on the Cockcroft-Gault equation * Total bilirubin \< 1.5 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \< 3 x ULN unless considered due to leukemic involvement * Ability to understand and provide signed informed consent * Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug * Only patients who are relapsed, refractory, or intolerant of standard AML therapy will be eligible for Part 1 (minimum of 1 prior line of AML-directed therapy) Exclusion Criteria: * Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \[FAB\] class M3-AML) * Patients having received any prior BCL2 inhibitor therapy * Subject has known active central nervous system (CNS) involvement with AML * Patients with New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \< 40% by echocardiogram or multi-gated acquisition (MUGA) scan * Patients with a history of myocardial infarction within the last 6 months or unstable / uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias * Patients with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C * Patients with known dysphagia, short-gut syndrome, or other conditions that would affect the ingestion or gastrointestinal absorption of drugs administered orally * Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study * Subject has a white blood cell count \> 25 x 10{9}/L. (Note: hydroxyurea is permitted to meet this criterion) * Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (a) appropriate method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide)
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Can a CDK8/CDK19 blocker help when leukemia and MDS return?
- Can a new combo drug tame childhood leukemia that Won't quit?
- Can a 'Universal' cancer target outsmart resistant blood cancers?
- Can a new oral drug take on hard-to-treat leukaemia?
- Weekly pill cocktail aims to tame resistant blood cancers