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Venetoclax with Chemotherapy for Acute Myeloid Leukemia

This study is testing venetoclax along with combination chemotherapy (fludarabine, cytarabine, filgrastim, and idarubicin) for patients with newly diagnosed acute myeloid leukemia (AML) or AML that has returned or not responded to previous treatments. Venetoclax may work by blocking enzymes that cancer cells need to grow. The chemotherapy drugs work in different ways to stop cancer cells. The study aims to find the best dose and side effects of this combination, and how well it works. Success will be measured by how many patients respond to the treatment, including complete or partial remission. You may be eligible if you are 18 or older and have AML or high-risk myelodysplastic syndrome (MDS). The current status of this study is unclear.

Study design
This is a phase 1b/2 interventional study, meaning it first looks for the best dose and then evaluates how well the treatment works. It plans to enroll 116 participants.
What's involved
Participants will receive venetoclax daily by mouth, and chemotherapy drugs (fludarabine, cytarabine, idarubicin) and filgrastim or pegfilgrastim by injection or IV. Treatment cycles repeat every 28 days for up to two cycles.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured for up to 6 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03214562

Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~116 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:CytarabineFilgrastimFludarabineIdarubicinPegfilgrastimVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over Up to 6 years
+9 more outcomes measured

Conditions

High Risk Myelodysplastic Syndrome
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Courtney DiNardo · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

DiNardo, MD
[email protected]
(713) 794-1141
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Overall response rate (ORR)Up to 6 years

    Defined as complete response (CR) + CR with incomplete blood count recovery (CRi) + partial response (PR). Will be estimated along with the 95% credible interval.

  • CR/CRi rateUp to 6 years

    Will be estimated along with the 95% credible interval.

  • Hematologic responseUp to 6 years

    Will be estimated along with the 95% credible interval.

  • Duration of responseFrom the date of initial response, assessed up to 6 years

    Defined as the number of days from the date of initial response (PR or better) to the date of first documented disease progression/relapse or death, whichever occurs first. Will be calculated for all patients.

  • Event-free survivalFrom the date of treatment initiation, assessed up to 6 years

    Defined as the number of days from the date of treatment initiation (i.e., course 1 day 1) to the date of documented treatment failure, relapses from CR, or death from any cause, whichever occurs first. Will be calculated for all patients. Estimated using Kaplan-Meier method. Log-rank tests will be used to compare among subgroups of patients.

  • Overall survivalUp to 6 years

    Estimated using Kaplan-Meier method. Log-rank tests will be used to compare among subgroups of patients.

  • Anti-tumor activityUp to 6 years

    Will be summarized graphically and with descriptive statistics.

  • Pharmacodynamic markersUp to 6 years

    Two samples t-test /Wilcoxon rank sum tests will be used to compare pharmacodynamics/pharmacokinetics (PD/PK) parameters between responder and non-responders, and logistic regression analysis will also be used to evaluate the association of PD/PK parameters with response.

  • Drug exposure levelsUp to 6 years

    Will be summarized graphically and with descriptive statistics.

  • Overall incidence and severity of all adverse eventsUp to 6 years

    Graded using Common Toxicity Criteria version 4.0. Safety data will be summarized using frequency and percentage, by category and severity.