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

Last updated: April 18, 2025
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Acute Myeloid Leukemia

Platelet Disorders

Leukemia

Treatment

N/A

Clinical Study ID

NCT06058741
P23-498
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Confirmed diagnosis of primary or secondary acute myeloid leukemia (AML), deemedineligible 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 havebeen reached prior to and independently of recruitment in the study.

  • Treatment prescribed in accordance with the applicable approved label and localregulatory and reimbursement policies.

Exclusion

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 withinthe last 30 days. Participation in another post-marketing observational study orRegistry is acceptable

Study Design

Total Participants: 150
Study Start date:
March 04, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 261822

    Torette, Ancona 60020
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria delle Marche /ID# 261822

    Torette, Ancona 60020
    Italy

    Site Not Available

  • IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 259535

    Bologna, Emilia-Romagna 40138
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Careggi /ID# 259766

    Florence, Firenze 50134
    Italy

    Site Not Available

  • Ospedale Policlinico San Martino /ID# 258981

    Genoa, Genova 16132
    Italy

    Active - Recruiting

  • Ospedale San Martino /ID# 258981

    Genoa, Genova 16132
    Italy

    Site Not Available

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 260737

    Reggio Calabria, L Aquila 89124
    Italy

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas /ID# 259300

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • AST Pesaro Urbino /ID# 261400

    Pesaro, Marche 61122
    Italy

    Site Not Available

  • ASST Valle Olona/Ospedale di Busto Arsizio /ID# 259833

    Busto Arsizio, Milano 21052
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 259455

    Milan, Milano 20162
    Italy

    Site Not Available

  • Istituto Clinico Humanitas /ID# 259300

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 261794

    Naples, Napoli 80131
    Italy

    Site Not Available

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258720

    Torino, Piemonte 10126
    Italy

    Site Not Available

  • AOU Citta della Salute e della Scienza di Torino /ID# 258720

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • Presidio Ospedaliero Vito Fazzi /ID# 261222

    Lecce, Puglia 73100
    Italy

    Site Not Available

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 260963

    Meldola, Reggio Emilia 47014
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 260683

    Rome, Roma 00133
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 260821

    Rome, Roma 00161
    Italy

    Site Not Available

  • Fondazione PTV Policlinico Tor Vergata /ID# 260683

    Rome, Roma 00133
    Italy

    Active - Recruiting

  • Sapienza University /ID# 260821

    Rome, Roma 00161
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria delle Marche /ID# 261822

    Ancona, 60020
    Italy

    Site Not Available

  • ASST Papa Giovanni XXIII /ID# 258727

    Bergamo, 24127
    Italy

    Site Not Available

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 259535

    Bologna, 40138
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 259535

    Bologna, 40138
    Italy

    Active - Recruiting

  • A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 261223

    Catania, 95123
    Italy

    Active - Recruiting

  • AOU Policlinico G. Rodolico - San Marco /ID# 261223

    Catania, 95123
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco - Catania /Id# 261223

    Catania, 95123
    Italy

    Active - Recruiting

  • Presidio Ospedaliero Gaspare Rodolico /ID# 261223

    Catania, 95123
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 260738

    Milan, 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 260738

    Milano, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Modena /ID# 259189

    Modena, 41124
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 259778

    Novara, 28100
    Italy

    Site Not Available

  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 261146

    Palermo, 90146
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 261146

    Palermo, 90146
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo /ID# 259624

    Pavia, 27100
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 258983

    Perugia, 06156
    Italy

    Site Not Available

  • Azienda Sanitaria Locale Pescara-Presidio Ospedaliero S.Spirito /ID# 261304

    Pescara, 65124
    Italy

    Site Not Available

  • Azienda Ospedaliera Bianchi Melacrino Morelli /ID# 260737

    Reggio Calabria, 89125
    Italy

    Active - Recruiting

  • Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 260737

    Reggio Calabria, 89125
    Italy

    Site Not Available

  • Fondazione Policlinico Tor Vergata /ID# 260683

    Roma, 00133
    Italy

    Site Not Available

  • AOU San Giovanni di Dio Ruggi d'Aragona - Scuola Medica Salernitana /ID# 259456

    Salerno, 84131
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 259456

    Salerno, 84131
    Italy

    Active - Recruiting

  • Azienda Sanitaria Universitaria Giuliano Isontina /ID# 261298

    Trieste, 34128
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata di Verona /ID# 260809

    Verona, 37134
    Italy

    Site Not Available

  • Ospedale Belcolle /ID# 259563

    Viterbo, 01100
    Italy

    Site Not Available

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