Actively Recruiting
Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia
Led by Hospital Municipal São José · Updated on 2024-08-05
100
Participants Needed
5
Research Sites
239 weeks
Total Duration
On this page
Sponsors
H
Hospital Municipal São José
Lead Sponsor
H
Hospital de Clínicas da UFPR. Curitiba, PR, Brazil
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.
CONDITIONS
Official Title
Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML according to World Health Organization criteria.
- Ineligibility for induction chemotherapy due to age 70 years or older, or for those aged 18 to 74 years, having an ECOG performance status of 2 or 3, creatinine clearance below 60 mL/min/1.73m², or left ventricular ejection fraction 50% or less.
- Projected life expectancy of at least 12 weeks.
- Not requiring supplemental oxygen or renal replacement therapy.
- Female participants must be postmenopausal, surgically sterile, or use at least one specified method of birth control from Study Day 1 through 180 days after the last dose.
- Male participants must agree to use specified contraception methods and avoid sperm donation from Study Day 1 through 180 days after the last dose.
- Must voluntarily sign informed consent before any screening or study procedures.
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL).
- Known central nervous system involvement with AML.
- Known infection with HIV, hepatitis B virus, hepatitis C virus, or other active infections requiring treatment.
- History of other malignancies before the study, except for non-melanoma skin cancer.
- Chronic liver disease and cirrhosis with Child-Pugh class B or C.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hospital Ophir Loyola
Belém, Brazil
Not Yet Recruiting
2
Hospital de Clínicas da UFPR
Curitiba, Brazil
Not Yet Recruiting
3
Hospital Universitario Polydoro Ernani de Sao Thiago
Florianópolis, Brazil
Not Yet Recruiting
4
Hospital Amaral Carvalho
Jaú, Brazil
Actively Recruiting
5
Hospital Municipal Sao Jose
Joinville, Brazil
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here