Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatm… (NCT04763928) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax
Italy101 participantsStarted 2021-12-03
Plain-language summary
Prospective, multi-center, intervention, open clinical trial for the treatment of AML secondary to MPN in patients unfit for intensive chemotherapy investigating a combination regimen including VEN and DEC.
Who can participate
Age range60 Years
SexALL
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Inclusion criteria
✓. 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 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
Exclusion criteria
✕. Diagnosis of de novo AML
✕. Pre-existing, uncontrolled pathology such as heart failure (congestive/ischaemic, acute myocardial infarction within the post 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 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.
What they're measuring
1
Efficacy of VEN-DEC regimen (event free survival)
Timeframe: at 1 year
Trial details
NCT IDNCT04763928
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto