Combining venetoclax, cytarabine, and metformin for treating difficult cases of 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
PHASE2 · Hospital Municipal São José · NCT06537843
This study is testing a new combination of medications to see if it helps people with tough cases of acute myeloid leukemia who can’t use standard treatments.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Municipal São José (other) |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Belém and 4 other locations) |
| Trial ID | NCT06537843 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial evaluates the safety and efficacy of a combination treatment involving venetoclax, cytarabine, and metformin for patients with relapsed-refractory acute myeloid leukemia (AML) or those ineligible for standard induction therapy. Participants will be enrolled after providing informed consent and must meet specific eligibility criteria, including a confirmed diagnosis of AML and certain health conditions that prevent them from receiving traditional chemotherapy. The study aims to assess how well this combination therapy works in improving outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates include patients aged 70 and older or younger patients with specific health conditions that make them ineligible for standard induction chemotherapy.
Not a fit: Patients who are not diagnosed with acute myeloid leukemia or those who are eligible for standard induction chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat acute myeloid leukemia.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using combination therapies for AML, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Belém and 4 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia