Clinical trial NCT06058741: A Study to Asses Effectiveness and Treatment Management of Oral Venetoclax Tablets + Subcutaneously Injected Azacitidine in Adult Participants Ineligible for Intensive Chemotherapy With de Novo Acute Myeloid Leukemia (AML) in Italy
Official title: Venetoclax Real-World Observational Study on Effectiveness and Treatment Management in Patients With Newly Diagnosed AML Who Are Ineligible for Intensive Chemotherapy in Italy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Venetoclax
Venclexta
Venclyxto
Azacitidine
ABT-199
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed AML participants who are ineligible to intensive chemotherapy, that starting treatment with Venetoclax in combination with azacitadine treated according to the Italian label.

Brief summary: Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax in combination with azacitidine works to treat AML in newly diagnosed adult participants who are ineligible for intensive chemotherapy in Italy.

Venetoclax in combination with azacitidine is approved in Italy to treat Acute myeloid leukemia (AML) in newly diagnosed adults who are ineligible for intensive chemotherapy. All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 150 participants will be enrolled in the study at approximately 20-25 sites in Italy.

Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) injection according to the approved local label. The duration of the study is approximately 18 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 18 months.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of primary or secondary acute myeloid leukemia (AML), deemed ineligible for intensive induction chemotherapy because of age, performance status, comorbidities or any other clinical reason as defined by the treating physician.
* Investigator decision on patient treatment with venetoclax + azacitidine must have been reached prior to and independently of recruitment in the study.
* Treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.

Exclusion Criteria:

* Participants affected by Acute Promyelocytic Leukemia.
* Prior treatment for AML, excluding hydroxyurea.
* Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another post-marketing observational study or Registry is acceptable

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi /ID# 259766
state: Firenze
city: Genoa
country: Italy
facility: Ospedale San Martino /ID# 258981
state: Genova
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas /ID# 259300
state: Lombardia
city: Pesaro
country: Italy
facility: AST Pesaro Urbino /ID# 261400
state: Marche
city: Busto Arsizio
country: Italy
facility: ASST Valle Olona/Ospedale di Busto Arsizio /ID# 259833
state: Milano
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 259455
state: Milano
city: Naples
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 261794
state: Napoli
city: Torino
country: Italy
facility: A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258720
state: Piemonte
city: Lecce
country: Italy
facility: Presidio Ospedaliero Vito Fazzi /ID# 261222
state: Puglia
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 260963
state: Reggio Emilia
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260683
state: Roma
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 260821
state: Roma
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche /ID# 261822
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII /ID# 258727
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 259535
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico - San Marco /ID# 261223
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 260738
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena /ID# 259189
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 259778
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261146
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo /ID# 259624
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 258983
city: Pescara
country: Italy
facility: Azienda Sanitaria Locale Pescara-Presidio Ospedaliero S.Spirito /ID# 261304
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 260737
city: Salerno
country: Italy
facility: AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 259456
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina /ID# 261298
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona /ID# 260809
city: Viterbo
country: Italy
facility: Ospedale Belcolle /ID# 259563
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: