Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venetoclax, Cytarabine Injection, Metformin.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Venetoclax
Venetoclax, PO (tablet), 200 - 400mg, once-daily, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles). - Drug Cytarabine Injection
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). - Drug Metformin
Metformin, PO (tablet), 850mg, three times a day, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).
Primary outcome measures
- Overall Survival (OS) [Time frame: 12 months and 24 months]
Secondary outcome measures (2)
- Composite Complete Response Rate (CCR) [Time frame: 12 months and 24 months]
- Negative Measurable Residual Disease (MRD) Rate [Time frame: 12 months and 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 5 centers
- Hospital Ophir Loyola — Belém
- Hospital de Clínicas da UFPR — Curitiba
- Hospital Universitario Polydoro Ernani de Sao Thiago — Florianópolis
- Hospital Amaral Carvalho — Jaú
- Hospital Municipal Sao Jose — Joinville
Identifiers
NCT: NCT06537843 · VenCM-001