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An open-label, single-arm, pilot study of Venetoclax in combination with 5 days Azacitidine in treatment-naïve subjects with acute myelogenous leukemia who are ≥18 years of age and not eligible for standard induction therapy (VENAZA-5S PILOT TRIAL)
EU CTIS ID: 2022-501537-23-00
What this study is testing
The primary objective of the trial is to generate first data on the efficacy of the combination of Venetoclax and 5-day courses of Azacitidine in the studied patient population in a descriptive manner.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Confirmed diagnosis of AML by WHO criteria 2016 AND ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or comorbidities
- Age ≥ 18 years
- Projected life expectancy of at least 12 weeks
- Adequate renal and liver function
You likely can't join if
- Prior treatment for AML or MDS with one of the following: HMA, Chemotherapeutic agent, CAR-T cell therapy, Experimental therapies; (NOTE: Prior use of hydroxyurea is allowed)
- History of other malignancies with the exception of adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
- History of myeloproliferative neoplasm (MPN)
- Diagnosis of acute promyelocytic leukemia (APL)
- Presence of favorable-risk karyotype abnormalities, i.e. t(15;17), t(8;21), inv(16) or t(16;16)
- Known active CNS involvement with AML
See the full eligibility criteria
- Confirmed diagnosis of AML by WHO criteria 2016 AND ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or comorbidities
- Age ≥ 18 years
- Projected life expectancy of at least 12 weeks
- Adequate renal and liver function
- Prior treatment for AML or MDS with one of the following: HMA, Chemotherapeutic agent, CAR-T cell therapy, Experimental therapies; (NOTE: Prior use of hydroxyurea is allowed)
- History of other malignancies with the exception of adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
- History of myeloproliferative neoplasm (MPN)
- Diagnosis of acute promyelocytic leukemia (APL)
- Presence of favorable-risk karyotype abnormalities, i.e. t(15;17), t(8;21), inv(16) or t(16;16)
- Known active CNS involvement with AML
- Known to be positive for HIV, Hepatitis B or C
- Cardiovascular disability status of NYHA > 2
- Chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study
- Evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.