Clinical trial NCT06537843: Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia
Official title: Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia: Multicenter, Phase 2, Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Hospital Municipal São José
Sponsor class: OTHER
Collaborators: name: Hospital de Clínicas da UFPR. Curitiba, PR, Brazil
name: Hospital Ophir Loyola. Belem, PA, Brazil
name: Hospital Universitario Polydoro Ernani de São Thiago. Florianopolis, SC, Brazil
name: Hospital Amaral Carvalho. Jau, SP, Brazil
First posted: 2024-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort 1: Newly diagnosed, induction-ineligible AML patients Cohort 2: Relapsed-refractory AML patients
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 12 months and 24 months
Secondary outcomes:
measure: Composite Complete Response Rate (CCR)
timeFrame: 12 months and 24 months
measure: Negative Measurable Residual Disease (MRD) Rate
timeFrame: 12 months and 24 months
Other outcomes:
Locations:
city: Belem
country: Brazil
facility: Hospital Ophir Loyola
city: Curitiba
country: Brazil
facility: Hospital de Clínicas da UFPR
city: Florianopolis
country: Brazil
facility: Hospital Universitario Polydoro Ernani de Sao Thiago
city: Jaú
country: Brazil
facility: Hospital Amaral Carvalho
city: Joinville
country: Brazil
facility: Hospital Municipal Sao Jose
Study officials:
References: