Last updated 4 months ago
Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia
100 patients around the world
Available in Brazil
Subjects will be included voluntarily after informed consent. Diagnosis of AML in
accordance with the WHO classification and determination of inegibility to induction
therapy or refractory or relapsed disease after initial treatment.
Hospital Municipal São José
4Research sites
100Patients around the world
This study is for people with
Leukemia
Acute myeloid leukemia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Hospital Ophir Loyola
Hospital De Clínicas Da Universidade Federal Do Paraná
Polydoro Ernani de São Thiago University Hospital
Hospital Amaral Carvalho
Recruiting
StudyVenCM
SponsorHospital Municipal São José
Conditions
Acute myeloid leukemia
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06537843
