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

Recruiting now · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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

Key facts

Study ID

NCT06537843

Run by

Hospital Municipal São José

People needed

100

Starts

2023-12-01

Expected to finish

2028-07-01

Last updated by the study team

2024-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Amaral Carvalho — Jaú, Brazil (enrolling)
• Hospital Municipal Sao Jose — Joinville, Brazil (enrolling)
• Hospital Ophir Loyola — Belém, Brazil
• Hospital de Clínicas da UFPR — Curitiba, Brazil
• Hospital Universitario Polydoro Ernani de Sao Thiago — Florianópolis, Brazil

Full record on ClinicalTrials.gov

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