Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia

Summary

Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.

Eligibility

Inclusion Criteria:

* Diagnosis of AML in accordance with the World Health Organization criteria.
* Ineligibility for induction chemotherapy due to age (≥ 70 years) or, for patients 18 to 74 years of age, ECOG-PS 2 or 3, creatinine clearance below 60 mL/min/1,73m², left ventricular ejection fraction ≤ 50%.
* Projected life expectancy of at least 12 weeks.
* Not requiring supplemental oxygen or substitutive renal therapy.
* Female participants must be either postmenopausal, surgically sterile or practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
* Male participants must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice protocol specified methods of contraception and to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
* Participant must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia (APL).
* Known central nervous system (CNS) involvement with AML.
* Known human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, or other active viral, bacterial or fungal infection requiring treatment.
* History of other malignancies prior to study entry, with the exception of non-melanoma skin cancer.
* Chronic Liver Disease and Cirrhosis with a class B or C Child-Pugh score.

Conditions2

Interventions3

Related trials

• A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis — The Hospital for Sick Children
• A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes — Boryung Pharmaceutical Co., Ltd
• Acupuncture or Metformin for Insulin Resistance in Women With PCOS — Karolinska Institutet
• Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis. — Institute of Liver and Biliary Sciences, India
• Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes — National Institute of Cardiology, Warsaw, Poland
• Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients — Mostafa Bahaa
• Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People (MOWRI) — University Of Nigeria Teaching Hospital
• Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD) — Shinshu University

Browse More Trials