Acute Myeloid LeukemiaPhase 2VenCMNCT06537843
Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia
A Phase 2 study testing Venetoclax, Cytarabine Injection and Metformin in people with Acute Myeloid Leukemia, run by Hospital Municipal São José at 5 sites in Brazil.
Trial summary
Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Venetoclax, Cytarabine Injection and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesBrazil
- Study dates
- 1 Dec 2023to 1 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Brazil5 sites, 5 recruiting
- Not yet recruiting
Hospital Ophir Loyola
Belém
Thiago Carneiro, MD, PhD
- Not yet recruiting
Hospital de Clínicas da UFPR
Curitiba
Elenaide Nunes, MD, PhD
- Not yet recruiting
Hospital Universitario Polydoro Ernani de Sao Thiago
Florianópolis
Giovanna Steffenello, MD, MSc
- Recruiting
Hospital Amaral Carvalho
Jaú
Ederson Mattos, MD, +55 (14) 3602-1200, edersonmattos@amaralcarvalho.org.br
- Recruiting
Hospital Municipal Sao Jose
Joinville
Marcelo Lacerda, MD, PhD, +55 (47) 3441-6600, marcelo.lacerda@univille.br
About this study
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
Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Venetoclax, Cytarabine Injection, Metformin
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Venetoclax, PO (tablet), 200 - 400mg, once-daily, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).
Cytarabine InjectionDrug
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).
MetforminDrug
Metformin, PO (tablet), 850mg, three times a day, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).
| Study group | Role | What they receive |
|---|---|---|
| VenCM | Experimental | Venetoclax, Cytarabine, Metformin Receives: Drug: Venetoclax; Drug: Cytarabine Injection; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival is defined as the time from patient inclusion to the date of death, using Kaplan-Meier methodology.
Measured: 12 months and 24 months
Secondary outcomes (2)
Composite Complete Response Rate (CCR)
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.
Measured: 12 months and 24 months
Negative Measurable Residual Disease (MRD) Rate
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.
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Dec 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort 1: Newly diagnosed, induction-ineligible AML patients Cohort 2: Relapsed-refractory AML patients
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Municipal São José
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clínicas da UFPR. Curitiba, PR, Brazil, Hospital Ophir Loyola. Belem, PA, Brazil, Hospital Universitario Polydoro Ernani de São Thiago. Florianopolis, SC, Brazil, Hospital Amaral Carvalho. Jau, SP, Brazil
- Responsible party
- Principal investigator, Marcelo Pitombeira de Lacerda, Hospital Municipal São José
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537843
- Sponsor's protocol ID
- VenCM-001
- Acronym
- VenCM
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06537843
- Acronym / sponsor ID
- VenCM / VenCM-001
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Municipal São JoséUniversity, hospital or other
- Collaborators
- Hospital de Clínicas da UFPR. Curitiba, PR, Brazil, Hospital Ophir Loyola. Belem, PA, Brazil, Hospital Universitario Polydoro Ernani de São Thiago. Florianopolis, SC, Brazil, Hospital Amaral Carvalho. Jau, SP, Brazil
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort 1: Newly diagnosed, induction-ineligible AML patients Cohort 2: Relapsed-refractory AML patients
| Arm | Type | Receives |
|---|---|---|
| VenCM | Experimental | Drug: Venetoclax, Drug: Cytarabine Injection, Drug: MetforminVenetoclax, Cytarabine, Metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxVenetoclax, PO (tablet), 200 - 400mg, once-daily, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles). | Drug | VenCM |
| Cytarabine InjectionCytarabine, 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 | VenCM |
| MetforminMetformin, PO (tablet), 850mg, three times a day, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles). | Drug | VenCM |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax, Cytarabine Injection and Metformin in people with Acute Myeloid Leukemia, run by Hospital Municipal São José at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 12 months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.