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New treatment option for Acute Myeloid Leukemia
Official title Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS
ClinicalTrials.gov ID: NCT05342584
What this study is testing
What is Venetoclax Oral Tablet?
Venetoclax Oral Tablet is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1b, open-label study evaluating Venetoclax in combination with intensive induction and consolidation chemotherapy in previously untreated, adult patients with acute myeloid leukemia. In Part 1, the dose escalation phase, the safety and tolerability of the combination with Venetoclax at different doses and duration will inform the appropriate dose(s) and regimen(s) for Part 2.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- New diagnosis of AML by WHO criteria. Patients with higher risk MDS (R-IPSS\>3.5) and 10% blasts or more, or proliferative (WBC ≥ 13 x 10⁹/L) CMML-2...
- Patients ≥ 18 to ≤ 75 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Adequate renal function including creatinine clearance \> 30 mL/min based on the Cockcroft Gault equation.
- Adequate hepatic function including total bilirubin \< 1.5x ULN unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or...
You likely can't join if
- Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
- Subject has known active CNS involvement with AML
- Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \<45% by echocardiogram or multi-gated acquisition...
- Patients with a history of myocardial infarction within the last 6 months or unstable / uncontrolled angina pectoris or history of severe and/or...
- Patients with uncontrolled 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...
See the full eligibility criteria
- New diagnosis of AML by WHO criteria. Patients with higher risk MDS (R-IPSS\>3.5) and 10% blasts or more, or proliferative (WBC ≥ 13 x 10⁹/L) CMML-2 are also eligible at the discretion of the PI. Patients having...
- Patients ≥ 18 to ≤ 75 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Adequate renal function including creatinine clearance \> 30 mL/min based on the Cockcroft Gault equation.
- Adequate hepatic function including total bilirubin \< 1.5x ULN unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT \< 3x ULN unless considered due to leukemic involvement
- Ability to understand and provide signed informed consent
- Male people 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.
- Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
- Subject has known active CNS involvement with AML
- Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \<45% 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 uncontrolled 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 10⁹/L. (Note: Hydroxyurea and/or cytarabine (up to 2 g/m\^2 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. Appropriate method(s) of...
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.