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

NCT06537843 | Recruiting Phase 2 DMC

• 1 other identifier: VenCM-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival is defined as the time from patient inclusion to the date of death, using Kaplan-Meier methodology.

  12 months and 24 months

Secondary Outcomes (2)

• Composite Complete Response Rate (CCR)

  12 months and 24 months

• Negative Measurable Residual Disease (MRD) Rate

  12 months and 24 months

Study Arms (1)

VenCM

EXPERIMENTAL

Venetoclax, Cytarabine, Metformin

Drug: Venetoclax; Drug: Cytarabine Injection; Drug: Metformin

Interventions

Venetoclax DRUG

Venetoclax, PO (tablet), 200 - 400mg, once-daily, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).

VenCM

Cytarabine Injection DRUG

Cytarabine, Subcutaneous injection, 10 - 100mg per square meter, once-daily, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).

VenCM

Metformin DRUG

Metformin, PO (tablet), 850mg, three times a day, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).

VenCM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hospital Municipal São José: lead
• Hospital de Clínicas da UFPR. Curitiba, PR, Brazil: collaborator
• Hospital Ophir Loyola. Belem, PA, Brazil: collaborator
• Hospital Universitario Polydoro Ernani de São Thiago. Florianopolis, SC, Brazil: collaborator
• Hospital Amaral Carvalho. Jau, SP, Brazil: collaborator

Study Sites (5)

Hospital Ophir Loyola

Belém, Brazil

NOT YET RECRUITING

Hospital de Clínicas da UFPR

Curitiba, Brazil

NOT YET RECRUITING

Hospital Universitario Polydoro Ernani de Sao Thiago

Florianópolis, Brazil

NOT YET RECRUITING

Hospital Amaral Carvalho

Jaú, Brazil

RECRUITING

Hospital Municipal Sao Jose

Joinville, Brazil

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Cytarabine; Metformin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Hematology Specialist

Model Details: Cohort 1: Newly diagnosed, induction-ineligible AML patients Cohort 2: Relapsed-refractory AML patients

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 5, 2024

Record last verified: 2024-07

Locations

BR (5)