NCT06537843 Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia
| NCT ID | NCT06537843 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hospital Municipal São José |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2023-12-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.
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.
Frequently Asked Questions
Who can join the NCT06537843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06537843 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06537843 currently recruiting?
Yes, NCT06537843 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospital Municipal São José to inquire about joining.
Where is the NCT06537843 trial being conducted?
This trial is being conducted at Belém, Brazil, Curitiba, Brazil, Florianópolis, Brazil, Jaú, Brazil and 1 additional location.
Who is sponsoring the NCT06537843 clinical trial?
NCT06537843 is sponsored by Hospital Municipal São José. The trial plans to enroll 100 participants.
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