RecruitingPhase 2NCT06537843

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

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

Sponsor

Hospital Municipal São José

Enrollment

100 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding metformin (a common diabetes drug with anti-cancer properties) to the standard venetoclax and cytarabine combination can improve outcomes in AML (acute myeloid leukemia) patients who are either too frail for intensive chemotherapy or whose cancer has returned. **You may be eligible if...** - You have confirmed AML - You are 70 or older, OR you are aged 18–74 but too frail for intensive chemotherapy (based on performance status or organ function criteria) - Your life expectancy is at least 12 weeks - You do not need oxygen support or dialysis **You may NOT be eligible if...** - You require supplemental oxygen or kidney dialysis - You are pregnant, nursing, or not willing to use contraception - Your health is too unstable for study treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

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

DRUGCytarabine 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).

DRUGMetformin

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

Locations(5)

Hospital Ophir Loyola

Belém, Brazil

Hospital de Clínicas da UFPR

Curitiba, Brazil

Hospital Universitario Polydoro Ernani de Sao Thiago

Florianópolis, Brazil

Hospital Amaral Carvalho

Jaú, Brazil

Hospital Municipal Sao Jose

Joinville, Brazil

View Full Details on ClinicalTrials.gov

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NCT06537843

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