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NCT Number: NCT06537843

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Ophir Loyola, Belém, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venetoclax

Drug

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

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).

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).

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 12 months and 24 months

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

Secondary outcomes

  1. Composite Complete Response Rate (CCR)

    Time frame: 12 months and 24 months

    Percentage of participants with complete remission (CR) or complete remission with partial (CRh) or incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the 2022 European LeukemiaNet AML Diagnosis and Treatment Recommendations.

  2. Negative Measurable Residual Disease (MRD) Rate

    Time frame: 12 months and 24 months

    Percentage of participants with CR, CRh or CRi with negative measurable residual disease (MRD) as assessed by the investigator, in accordance with ELN recommendations, defined as having less than 10-³ residual blasts per leukocyte measured in the bone marrow.

Sponsors and collaborators

Lead sponsor

Hospital Municipal São José

Other

Collaborators

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

Registry information

Official study title

Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia: Multicenter, Phase 2, Clinical Trial

Acronym: VenCM

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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