Venetoclax, cytarabine and metformin for hard-to-treat acute myeloid leukemia
Tests venetoclax, cytarabine and metformin together in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia
Key facts
- Where
- Belém, Curitiba, Florianópolis, Jaú, and Joinville, BrazilSee the 5 sites
- Phase
- Phase 2
Where in Brazil
- Hospital Ophir LoyolaBelém, BrazilNot yet recruiting
- Hospital de Clínicas da UFPRCuritiba, BrazilNot yet recruiting
- Hospital Universitario Polydoro Ernani de Sao ThiagoFlorianópolis, BrazilNot yet recruiting
- Hospital Amaral CarvalhoJaú, BrazilTaking people
- Hospital Municipal Sao JoseJoinville, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Municipal São José
- Trial code
- NCT06537843
- Record updated
- 5 August 2024
- Original description
Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.Read full original descriptionShow less
Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia: Multicenter, Phase 2, Clinical Trial
Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.
Inclusion: 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: 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; Diagnosis of acute promyelocytic leukemia (APL); Known central nervous system (CNS) involvement with AML.