Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Drug: Venetoclax+Decitabine
- Registration Number
- NCT04763928
- Brief 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.
- Detailed Description
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 to improve the survival outcome.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 101
- 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
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VenDec Venetoclax+Decitabine Patients will receive a combination of VENETOCLAX (400 mg per day orally on days 1 to 28 of 28-days courses) and DECITABINE (20 mg/sqm intravenously on days 1 to 5 of 28-days courses)
- Primary Outcome Measures
Name Time Method Efficacy of VEN-DEC regimen (event free survival) at 1 year Evaluation of the event free survival at 1 year of an experimental VEN-DEC combination arm in patients with AML secondary to MPN and unfit for intensive therapeutic strategy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
Ematologia AOU delle Marche
🇮🇹Ancona, Italy
Ematologia AOU Policlinico Bari
🇮🇹Bari, Italy
Ematologia ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Ematologia IRCCS AOU di Bologna
🇮🇹Bologna, Italy
Ematologia ASST Spedali Civili di Brescia
🇮🇹Brescia, Italy
Ematologia Businco
🇮🇹Cagliari, Italy
Ematologia Istituto Oncologico Veneto IRCCS
🇮🇹Castelfranco Veneto, Italy
Ematologia AOU Policlinico Rodolico-San Marco
🇮🇹Catania, Italy
Ematologia A.O.U Arcispedale S.Anna
🇮🇹Cona, Italy
Ematologia Ospedale A.Carle
🇮🇹Cuneo, Italy
Ematologia IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Ematologia AOU di Modena
🇮🇹Modena, Italy
Ematologia AORN Cardarelli
🇮🇹Napoli, Italy
Ematologia Federico II
🇮🇹Napoli, Italy
Ematologia P.O. A.Tortora
🇮🇹Pagani, Italy
Ematologia AOU Policlinico Giaccone
🇮🇹Palermo, Italy
Ematologia Santa Maria della Misericordia
🇮🇹Udine, Italy
Ematologia PO Santo Spirito ASL Pescara
🇮🇹Pescara, Italy
Ematologia Ospedale S.M.delle Croci
🇮🇹Ravenna, Italy
Ematologia AOU S.Andrea
🇮🇹Roma, Italy
Ematologia Fondazione PTV
🇮🇹Roma, Italy
Ematologia Ospedale Sant'Eugenio
🇮🇹Roma, Italy
Ematologia Policlinico Gemelli
🇮🇹Roma, Italy
Ematologia Policlinico Umberto I
🇮🇹Roma, Italy
Ematologia Policlinico Santa Maria alle Scotte
🇮🇹Siena, Italy
Ematologia A.O.S. Maria Di Terni
🇮🇹Terni, Italy
Ematologia Città della Salute e della Scienza
🇮🇹Torino, Italy
Ematologia ORDINE MAURIZIANO DI TORINO
🇮🇹Torino, Italy
Ematologia ASST SETTE LAGHI
🇮🇹Varese, Italy
Ematologia Ospedale Belcolle
🇮🇹Viterbo, Italy
Az. Ospedaliero - Universitaria Careggi
🇮🇹Firenze, Italy