Clinical trial NCT04763928: Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax
Official title: A Phase 2, Prospective, Multi-center Intervention Trial in Patients With Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasms Unfit for Intensive Chemotherapy Investigating a Treatment Combination Including Decitabine and Venetoclax
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 101
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Patients unfit for intensive treatment modalities at the discretion of the investigator.
3. ECOG performance status 0-2 or disease-related reversible ECOG 3 score following adequate supportive care.
4. Signed written informed consent according to ICH/EU/GCP and national local laws.
5. 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:

1. Diagnosis of de novo AML
2. 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.
3. 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.
4. Uncontrolled bacterial or fungal infections
5. QTc \>470 msec on screening ECG (Fridericia's formula)
6. A history of cancer that is not in remission phase following surgery and/or chemotherapy and/or radiotherapy with life expectancy \< 6 months.

Primary outcomes:
measure: Efficacy of VEN-DEC regimen (event free survival)
timeFrame: at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: Ematologia AOU delle Marche
city: Bari
country: Italy
facility: Ematologia AOU Policlinico Bari
city: Bergamo
country: Italy
facility: Ematologia ASST Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Ematologia IRCCS AOU di Bologna
city: Brescia
country: Italy
facility: Ematologia ASST Spedali Civili di Brescia
city: Cagliari
country: Italy
facility: Ematologia Businco
city: Castelfranco Veneto
country: Italy
facility: Ematologia Istituto Oncologico Veneto IRCCS
city: Catania
country: Italy
facility: Ematologia AOU Policlinico Rodolico-San Marco
city: Cona
country: Italy
facility: Ematologia A.O.U Arcispedale S.Anna
city: Cuneo
country: Italy
facility: Ematologia Ospedale A.Carle
city: Firenze
country: Italy
facility: Az. Ospedaliero - Universitaria Careggi
city: Genova
country: Italy
facility: Ematologia IRCCS Ospedale Policlinico San Martino
city: Modena
country: Italy
facility: Ematologia AOU di Modena
city: Napoli
country: Italy
facility: Ematologia AORN Cardarelli
city: Napoli
country: Italy
facility: Ematologia Federico II
city: Pagani
country: Italy
facility: Ematologia P.O. A.Tortora
city: Palermo
country: Italy
facility: Ematologia AOU Policlinico Giaccone
city: Perugia
country: Italy
facility: Ematologia Santa Maria della Misericordia
city: Pescara
country: Italy
facility: Ematologia PO Santo Spirito ASL Pescara
city: Ravenna
country: Italy
facility: Ematologia Ospedale S.M.delle Croci
city: Roma
country: Italy
facility: Ematologia AOU S.Andrea
city: Roma
country: Italy
facility: Ematologia Fondazione PTV
city: Roma
country: Italy
facility: Ematologia Ospedale Sant'Eugenio
city: Roma
country: Italy
facility: Ematologia Policlinico Gemelli
city: Roma
country: Italy
facility: Ematologia Policlinico Umberto I
city: Siena
country: Italy
facility: Ematologia Policlinico Santa Maria alle Scotte
city: Terni
country: Italy
facility: Ematologia A.O.S. Maria Di Terni
city: Torino
country: Italy
facility: Ematologia Città della Salute e della Scienza
city: Torino
country: Italy
facility: Ematologia ORDINE MAURIZIANO DI TORINO
city: Udine
country: Italy
facility: Ematologia Santa Maria della Misericordia
city: Varese
country: Italy
facility: Ematologia ASST SETTE LAGHI
city: Viterbo
country: Italy
facility: Ematologia Ospedale Belcolle
Study officials:
References: