BridgeMD
Study aimed at evaluating the efficacy of a combination treatment (decitabine and venetoclax) in patients with Acute Myeliode Leukemia who are ineligible or unresponsive to intensive chemotherapy.
EU CTIS ID: 2023-510241-16-00
What this study is testing
The primary objective of the trial is the efficacy of VEN-DEC regimen measured as event-free survival (EFS) in patients with AML secondary to MPN unfit for intensive chemotherapy.
- 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
- Patients with AML secondary to myeloproliferative neoplasms (sAML), untreated, newly diagnosed, according to WHO 2016 criteria based on conventional cytological, cytogenetic and immunophenotypic disease characterization
- Patients = 60 years or adult patients unfit for intensive treatment modalities at the discretion of the investigator.
- ECOG performance status 0-2 or disease-related reversible ECOG 3 score following adequate supportive care.
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Males enrolled in the study with partners who are women of childbearing potential, must be willing to use an acceptable barrier contraceptive method during the trial. Males should use contraception for 3 months after the last dose of decitabine. Females should use contraception for 1 month after the last dose of venetoclax or 6 months after the last dose of decitabine, whichever comes later.
You likely can't join if
- Diagnosis of de novo AML
- Pre-existing, uncontrolled pathology such as heart failure (congestive/ischaemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV), sever liver disease with total bilirubin >2,5 x ULN and/or ALT>3 ULN (unless attributable to AML), acute or chronic pancreatitis, kidney function impairment with Creatinine Clearance (CrCl) level <30ml/min (calculated by Cockcroft Gault formula)(unless attributable to AML) and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent or to cope with the intended treatment plan. For altered liver, pancreas and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures.
- Pre-existing HIV positive serology (i.e. already known before enrolment). The participation to the study will require serology testing for HIV positivity at baseline: in case of HIV positivity or refusal to perform HIV testing, the patient will be considered not eligible.
- Uncontrolled bacterial or fungal infections
- QTc >470 msec on screening ECG (Fridericia's formula)
- A history of cancer that is not in remission phase following surgery and/or chemotherapy and/or radiotherapy with life expectancy < 6 months.
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.