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New treatment option for Acute Myeloid Leukemia
Official title Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML
ClinicalTrials.gov ID: NCT06429098
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as ABT-199, ABT199.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This investigator-initiated, single-arm, phase II trial is aimed to evaluate the efficacy and safety of a venetoclax-based, anthracycline-free regimen in patients with newly diagnosed CBFβ::MYH11-positive acute myeloid leukemia.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults ≥ 18 years.
- Newly diagnosed CBFβ::MYH11(+) AML.
- Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Subject must voluntarily sign and date an informed consent, prior to the initiation of any screening or study-specific procedures. Ferrara's criteria...
- Age\>75 years.
You likely can't join if
- Subject has received treatment with a hypomethylating agent and/or other chemotherapeutic agents either conventional or experimental or targeted drug...
- Pregnant or lactating women.
- To the knowledge of the subject and investigator, subject may not be able to complete all study visits or procedures required by the study protocol...
- Other conditions deemed unsuitable for participation in this study by the investigator.
See the full eligibility criteria
- Adults ≥ 18 years.
- Newly diagnosed CBFβ::MYH11(+) AML.
- Performance status 0-3 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Subject must voluntarily sign and date an informed consent, prior to the initiation of any screening or study-specific procedures. Ferrara's criteria are used to determine whether a patient is unfit, and a patient is...
- Age\>75 years.
- There are serious underlying heart, lung, kidney, liver complications.
- There are active infections that do not respond to anti-infective therapy.
- There is cognitive impairment.
- Other comorbidities that the doctor determines are not suitable for intensive chemotherapy.
- Subject has received treatment with a hypomethylating agent and/or other chemotherapeutic agents either conventional or experimental or targeted drug therapy for AML (except oral hydroxyurea and/or leukocytometry to...
- Pregnant or lactating women.
- To the knowledge of the subject and investigator, subject may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or be unable to comply with the...
- Other conditions deemed unsuitable for participation in this study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.