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

Hospital Municipal São José

Status and phase

Enrolling

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Venetoclax

Drug: Metformin

Drug: Cytarabine Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06537843

VenCM-001

Details and patient eligibility

About

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

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.