Efficacy of Midostaurin Combined With Intensive Chemotherapy in Core Binding Factor Leukemia: A Phase II Clinical Trial
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: Samples from 34 adult patients newly diagnosed with core binding factor leukemia (CBFL) were collected both at the time of diagnosis and at relapse and were centrally analyzed. Eligible patients received either standard induction CT known as “3 + 7” or an equivalent regimen, according to the recruiting center's policy. Patients who achieved CR or CRi received 3 courses of high-dose ARA-C (Cytarabine) 3000 mg/m2 every 12 h on days 1, 3, and 5, along with midostaurin at the dose of 50 mg b.i.d from Day 8 to Day 21 as part of consolidation therapy. Following the completion of the consolidation phase, patients received midostaurin as a monotherapy at the dose of 50 mg b.i.d. for 1 year as continuation therapy. The CR rate was 97%; we recorded an OS rate of 73.52% and a DFS rate of 48.4% for the entire cohort. The RI was 38.8% in the CBFB::MYH11 and 66.6% in the RUNX1::RUNX1T1 group. MRD (Measurable Residual Disease) was assessed by RQ-PCR at 10 time points throughout the study, as indicated by arrows.
Source: American Journal of Hematology
DOI: 10.1002/ajh.27547
Authors: Roberto Cairoli, Arianna Gatti, Giovanni Grillo, Marta Rachele Stefanucci, Barbara Di Camillo, Monica Fumagalli, Mauro Krampera, Gianpaolo Nadali, Patrizia Zappasodi, Erika Borlenghi, Elisabetta Todisco, Marta Ubezio, Massimo Bernardi, Alfredo Molteni, Claudia Basilico, Mauro Turrini, Rosa Greco, Valentina Mancini, Marta Riva, Davide Paolo Bernasconi, Bruno Brando, Silvio Marco Veronese, Alessandro Beghini
Institutions: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, University of Milano-Bicocca, Azienda Ospedaliera Ospedale Civile di Legnano, Aziende Socio Sanitarie Territoriale Ovest Milanese, University of Milan, University of Padua, Azienda Ospedaliera San Gerardo, University of Verona, Policlinico San Matteo Fondazione, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Ospedale di Circolo di Busto Arsizio, Humanitas University, IRCCS Humanitas Research Hospital, IRCCS Ospedale San Raffaele, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele, Azienda Socio Sanitaria Territoriale di Cremona, Ospedale di Circolo e Fondazione Macchi, Aziende Socio Sanitarie Territoriale dei Sette Laghi, Ospedale Valduce
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Award: G4963010608
OpenAlex ID: W4405259244