Status:
RECRUITING
Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia
Lead Sponsor:
Hospital Municipal São José
Collaborating Sponsors:
Hospital de Clínicas da UFPR. Curitiba, PR, Brazil
Hospital Ophir Loyola. Belem, PA, Brazil
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06537843
Start Date
December 1 2023
End Date
July 1 2028
Last Update
August 5 2024
Active Locations (5)
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1
Hospital Ophir Loyola
Belém, Brazil
2
Hospital de Clínicas da UFPR
Curitiba, Brazil
3
Hospital Universitario Polydoro Ernani de Sao Thiago
Florianópolis, Brazil
4
Hospital Amaral Carvalho
Jaú, Brazil