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Gimema ALL

Roberto Mina, Maria Teresa Petrucci, Paolo Corradini, Stefano Spada, Francesca Patriarca, Chiara Cerrato, Lorenzo De Paoli, Norbert Pescosta, Roberto Ria, Alessandra Malfitano, Pellegrino Musto, Luca Baldini, Tommasina Guglielmelli, Barbara Gamberi, Donato Mannina, Giulia Benevolo, Renato Zambello, Antonietta Pia Falcone, Antonio Palumbo, Arnon Nagler, Valeria Calafiore, Roman Hájek, Andrew Spencer, Mario Boccadoro, Sara Bringhen
BACKGROUND: High-dose therapy with autologous stem cell transplantation (HDT-ASCT) and maintenance treatment with novel agents are the best options for patients with newly diagnosed multiple myeloma, increasing the rate of complete response (CR) and prolonging progression-free survival (PFS) and overall survival (OS). Indeed, the achievement of a CR is a predictor of long-term survival among transplant-eligible patients. However, it is unclear whether patients reaching a CR after induction treatment could receive less intense consolidation or avoid maintenance therapy...
May 28, 2018: Clinical Lymphoma, Myeloma & Leukemia
Chiara Cerrato, Francesco Di Raimondo, Lorenzo De Paoli, Stefano Spada, Francesca Patriarca, Claudia Crippa, Roberto Mina, Tommasina Guglielmelli, Dina Ben-Yehuda, Daniela Oddolo, Chiara Nozzoli, Emanuele Angelucci, Nicola Cascavilla, Rita Rizzi, Stefano Rocco, Luca Baldini, Elena Ponticelli, Magda Marcatti, Clotilde Cangialosi, Tommaso Caravita, Giulia Benevolo, Roberto Ria, Arnon Nagler, Pellegrino Musto, Paola Tacchetti, Paolo Corradini, Massimo Offidani, Antonio Palumbo, Maria Teresa Petrucci, Mario Boccadoro, Francesca Gay
PURPOSE: Maintenance demonstrated to improve survival in newly diagnosed multiple myeloma (NDMM) patients and the achievement of complete response (CR) is a strong predictor of survival. Nevertheless, the role of maintenance according to response after induction/consolidation has not been investigated so far. To evaluate the impact of maintenance according to response, we pooled together and retrospectively analyzed data from 955 NDMM patients enrolled in two trials (GIMEMA-MM-03-05 and RV-MM-PI-209)...
April 19, 2018: Journal of Cancer Research and Clinical Oncology
Fausto Castagnetti, Gabriele Gugliotta, Massimo Breccia, Alessandra Iurlo, Luciano Levato, Francesco Albano, Paolo Vigneri, Elisabetta Abruzzese, Giuseppe Rossi, Serena Rupoli, Francesco Cavazzini, Bruno Martino, Ester Orlandi, Patrizia Pregno, Mario Annunziata, Emilio Usala, Mario Tiribelli, Simona Sica, Massimiliano Bonifacio, Carmen Fava, Filippo Gherlinzoni, Monica Bocchia, Simona Soverini, Maria Teresa Bochicchio, Michele Cavo, Martinelli Giovanni, Giuseppe Saglio, Fabrizio Pane, Michele Baccarani, Gianantonio Rosti
The most frequent BCR-ABL1 fusion transcripts in chronic myeloid leukemia (CML) are the e13a2 (b2a2) and the e14a2 (b3a2) ones. In the imatinib era few studies addressing the prognostic significance of the BCR-ABL1 transcript type in early chronic phase CML have been published. Overall, these studies suggest that in e14a2 patients the response to imatinib is faster and deeper. To evaluate if the BCR-ABL1 transcript type (e13a2 compared to e14a2) affect the response to imatinib and the clinical outcome in newly diagnosed adult CML patients, 559 patients enrolled in 3 prospective studies (NCT00514488, NCT00510926, observational study CML/023) were analyzed...
August 2017: American Journal of Hematology
Sabina Chiaretti, Antonella Vitale, Marco Vignetti, Alfonso Piciocchi, Paola Fazi, Loredana Elia, Brunangelo Falini, Francesca Ronco, Felicetto Ferrara, Paolo De Fabritiis, Mario Luppi, Giorgio La Nasa, Alessandra Tedeschi, Catello Califano, Renato Fanin, Fausto Dore, Franco Mandelli, Giovanna Meloni, Robin Foà
In the GIMEMA LAL 0904 protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant...
December 2016: Haematologica
Francesco Lo-Coco, Laura Di Donato, Richard F Schlenk
No abstract text is available yet for this article.
March 24, 2016: New England Journal of Medicine
Gabriele Gugliotta, Fausto Castagnetti, Massimo Breccia, Antonella Gozzini, Emilio Usala, Angelo M Carella, Giovanna Rege-Cambrin, Bruno Martino, Elisabetta Abruzzese, Francesco Albano, Fabio Stagno, Luigia Luciano, Mariella D'Adda, Monica Bocchia, Francesco Cavazzini, Mario Tiribelli, Monia Lunghi, Antonietta Pia Falcone, Caterina Musolino, Luciano Levato, Claudia Venturi, Simona Soverini, Michele Cavo, Giuliana Alimena, Fabrizio Pane, Giovanni Martinelli, Giuseppe Saglio, Gianantonio Rosti, Michele Baccarani
The introduction of second-generation tyrosine-kinase inhibitors (TKIs) has generated a lively debate on the choice of first-line TKI in chronic phase, chronic myeloid leukemia (CML). Despite the TKIs have different efficacy and toxicity profiles, the planned use of two TKIs has never been investigated. We report on a phase 2 study that was designed to evaluate efficacy and safety of a treatment alternating nilotinib and imatinib, in newly diagnosed BCR-ABL1 positive, chronic phase, CML patients. One hundred twenty-three patients were enrolled...
June 2016: American Journal of Hematology
Francesco Zaja, Wilma Barcellini, Silvia Cantoni, Monica Carpenedo, Giuseppe Caparrotti, Valentina Carrai, Nicola Di Renzo, Cristina Santoro, Massimo Di Nicola, Dino Veneri, Federico Simonetti, Anna M Liberati, Valeria Ferla, Francesca Paoloni, Enrico Crea, Stefano Volpetti, Enrica Tuniz, Renato Fanin
In patients with immune thrombocytopenia (ITP) refractory to corticosteroids and intravenous immunoglobulins (IVIG), splenectomy may result at higher risk of peri-operative complications and, for this reason, potentially contraindicated. The thrombopoietin receptor agonists (TPO-RAs) romiplostim and eltrombopag have shown high therapeutic activity in primary ITP, but data of efficacy and safety regarding their use in preparation for splenectomy are missing. Thirty-one adult patients, median age 50 years, with corticosteroids and/or IVIG refractory persistent and chronic ITP who were treated with TPO-RAs (romiplostim= 24; eltrombopag= 7) with the aim to increase platelet count and allow a safer execution of splenectomy were retrospectively evaluated...
May 2016: American Journal of Hematology
Theo de Witte, Stefan Suciu, Liv Meert, Constantijn Halkes, Dominik Selleslag, Dominique Bron, Sergio Amadori, Roel Willemze, Petra Muus, Frédéric Baron
The primary objective of this trial was to assess the feasibility, toxicity profile, and antitumor activity of gemtuzumab ozogamicin (GO) combined with a chemotherapy remission-induction regimen in adults with untreated high-risk myelodysplastic syndrome (HR-MDS) or secondary acute myeloid leukemia (sAML). In this phase II trial, 30 patients with median age of 58 years received 1 day of GO as a 1-h infusion at the dose level of 5 mg/m(2) on day 7 of the remission-induction course further consisting of a continuous infusion of cytarabine 100 mg/m(2)/day for 10 days and idarubicin 12 mg/m(2)/day on days 1, 3, and 5...
December 2015: Annals of Hematology
María-Victoria Mateos, Sara Bringhen, Paul G Richardson, Juan Jose Lahuerta, Alessandra Larocca, Albert Oriol, Mario Boccadoro, Ramón García-Sanz, Francesco Di Raimondo, Dixie-Lee Esseltine, Helgi van de Velde, Avinash Desai, Anil Londhe, Jesús F San Miguel, Antonio Palumbo
Substantial efficacy has been demonstrated with bortezomib-melphalan-prednisone in phase III studies in transplant-ineligible myeloma patients using various twice-weekly and once-weekly bortezomib dosing schedules. In VISTA, the regimen comprised four 6-week twice-weekly cycles, plus five 6-week once-weekly cycles. In the GIMEMA MM-03-05 study, the bortezomib-melphalan-prednisone regimen was either per VISTA ('GIMEMA twice-weekly'), or comprised nine 5-week once-weekly cycles ('GIMEMA once-weekly'). In the GEM2005MAS65 study, the regimen comprised one 6-week twice-weekly cycle, plus five 5-week once-weekly cycles...
June 2014: Haematologica
Roelof Willemze, Stefan Suciu, Giovanna Meloni, Boris Labar, Jean-Pierre Marie, Constantijn J M Halkes, Petra Muus, Martin Mistrik, Sergio Amadori, Giorgina Specchia, Francesco Fabbiano, Francesco Nobile, Marco Sborgia, Andrea Camera, Dominik L D Selleslag, Francois Lefrère, Domenico Magro, Simona Sica, Nicola Cantore, Meral Beksac, Zwi Berneman, Xavier Thomas, Lorella Melillo, Jose E Guimaraes, Pietro Leoni, Mario Luppi, Maria E Mitra, Dominique Bron, Georges Fillet, Erik W A Marijt, Adriano Venditti, Anne Hagemeijer, Marco Mancini, Joop Jansen, Daniela Cilloni, Liv Meert, Paola Fazi, Marco Vignetti, Silvia M Trisolini, Franco Mandelli, Theo de Witte
PURPOSE: Cytarabine plays a pivotal role in the treatment of patients with acute myeloid leukemia (AML). Most centers use 7 to 10 days of cytarabine at a daily dose of 100 to 200 mg/m(2) for remission induction. Consensus has not been reached on the benefit of higher dosages of cytarabine. PATIENTS AND METHODS: The European Organisation for Research and Treatment of Cancer (EORTC) and Gruppo Italiano Malattie Ematologiche dell' Adulto (GIMEMA) Leukemia Groups conducted a randomized trial (AML-12; Combination Chemotherapy, Stem Cell Transplant and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia) in 1,942 newly diagnosed patients with AML, age 15 to 60 years, comparing remission induction treatment containing daunorubicin, etoposide, and either standard-dose (SD) cytarabine (100 mg/m(2) per day by continuous infusion for 10 days) or high-dose (HD) cytarabine (3,000 mg/m(2) every 12 hours by 3-hour infusion on days 1, 3, 5, and 7)...
January 20, 2014: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Sabina Chiaretti, Antonella Vitale, Gianni Cazzaniga, Sonia Maria Orlando, Daniela Silvestri, Paola Fazi, Maria Grazia Valsecchi, Loredana Elia, Anna Maria Testi, Francesca Mancini, Valentino Conter, Geertruy te Kronnie, Felicetto Ferrara, Francesco Di Raimondo, Alessandra Tedeschi, Giuseppe Fioritoni, Francesco Fabbiano, Giovanna Meloni, Giorgina Specchia, Giovanni Pizzolo, Franco Mandelli, Anna Guarini, Giuseppe Basso, Andrea Biondi, Robin Foà
The outcome of children and adults with acute lymphoblastic leukemia is markedly different. Since there is limited information on the distribution of clinico-biological variables in different age cohorts, we analyzed 5202 patients with acute lymphoblastic leukemia enrolled in the Italian multicenter AIEOP and GIMEMA protocols and stratified them in nine age cohorts. The highest prevalence of acute lymphoblastic leukemia was observed in children, although a second peak was recorded from the 4(th) decade onwards...
November 2013: Haematologica
Christian Ramos, Etta Rozen, María León, Adolfo Martínez T, Irma Olarte, Humberto Catellanos, Carlos Martínez, Efreen Montaño, Juan Kassack I, Jorge Zamora, Enrique Miranda, Andrés De la Ros, Mario Gutiérrez, Juan Collazo
BACKGROUND: GIMEMA ALL 0288 trial was designed to evaluate the impact of a 7-day prednisone (PDN) pretreatment on complete remission of acute lymphoblastic leukemia. We adopted this trial in 2007. AIM: To evaluate the results of treatment in two cohorts of patients with acute lymphoblastic leukemia, treated from 2007 to January 2009 and from February to December 2009. MATERIAL AND METHODS: We studied 99 patients treated in the first period (58 males) and 54 patients treated in the second period (33 males) The age of patients ranged from 16 to 60 years and 70% of patients were of high risk...
September 2011: Revista Médica de Chile
Agostino Cortelezzi, Giuseppe Gritti, Luca Laurenti, Antonio Cuneo, Stefania Ciolli, Nicola Di Renzo, Pellegrino Musto, Francesca R Mauro, Nicola Cascavilla, Lorenzo Falchi, Francesco Zallio, Vincenzo Callea, Francesco Maura, Sara Martinelli, Alfonso Piciocchi, Gianluigi Reda, Robin Foà
Low-dose alemtuzumab has shown a favourable toxicity profile coupled with good results in terms of efficacy in relapsed/refractory chronic lymphocytic leukaemia (CLL). We conducted a multicentre retrospective study on the routine clinical use of low-dose alemtuzumab in this patient setting. One hundred and eight relapsed/refractory CLL patients from 11 Italian centres were included in the analysis. All patients had an Eastern Cooperative Oncology Group performance status ≤2 and the majority (84%) had adenopathies <5 cm...
February 2012: British Journal of Haematology
Sergio Amadori, Roberto Stasi, Alberto M Martelli, Adriano Venditti, Giovanna Meloni, Fabrizio Pane, Giovanni Martinelli, Monia Lunghi, Livio Pagano, Daniela Cilloni, Elena Rossetti, Francesco Di Raimondo, Claudio Fozza, Luciana Annino, Francesca Chiarini, Francesca Ricci, Emanuele Ammatuna, Edoardo La Sala, Paola Fazi, Marco Vignetti
The mammalian target of rapamycin (mTOR) signalling pathway has emerged as an important therapeutic target for acute myeloid leukaemia (AML). This study assessed the combination of temsirolimus, an mTOR inhibitor, and lower-dose clofarabine as salvage therapy in older patients with AML. Induction consisted of clofarabine 20mg/m(2) on days 1-5 and temsirolimus 25mg (flat dose) on days 1, 8 and 15. Patients achieving complete remission with (CR) or without (CRi) full haematological recovery could receive monthly temsirolimus maintenance...
January 2012: British Journal of Haematology
Robin Foà
Acute lymphoblastic leukemia (ALL) is the most frequent neoplasm in children, while being relatively rare in adults. The outcome of children with ALL is far superior than that observed in adults, whose survival rates generally do not exceed 40%. A retrospective analysis recently carried out on a large series of cases enrolled in the AIEOP and GIMEMA protocols for the treatment of pediatric and adult ALL has documented specific differences among the various age cohorts examined, particularly in terms of incidence of molecular rearrangements, with the BCR/ABL rearrangement being detected in more than half of patients in the 6(th) decade of life...
June 22, 2011: Pediatric Reports
Massimo Breccia, Luca Mazzarella, Vincenzo Bagnardi, Davide Disalvatore, Giuseppina Loglisci, Giuseppe Cimino, Anna Maria Testi, Giuseppe Avvisati, Maria Concetta Petti, Clara Minotti, Roberto Latagliata, Robin Foà, Pier Giuseppe Pelicci, Francesco Lo-Coco
We investigated whether body mass index (BMI) correlates with distinct outcomes in newly diagnosed acute promyelocytic leukemia (APL). The study population included 144 patients with newly diagnosed and genetically confirmed APL consecutively treated at a single institution. All patients received All-trans retinoic acid and idarubicin according to the GIMEMA protocols AIDA-0493 and AIDA-2000. Outcome estimates according to the BMI were carried out together with multivariable analysis for the risk of relapse and differentiation syndrome...
January 5, 2012: Blood
Robin Foà, Antonella Vitale, Marco Vignetti, Giovanna Meloni, Anna Guarini, Maria Stefania De Propris, Loredana Elia, Francesca Paoloni, Paola Fazi, Giuseppe Cimino, Francesco Nobile, Felicetto Ferrara, Carlo Castagnola, Simona Sica, Pietro Leoni, Eliana Zuffa, Claudio Fozza, Mario Luppi, Anna Candoni, Ilaria Iacobucci, Simona Soverini, Franco Mandelli, Giovanni Martinelli, Michele Baccarani
Dasatinib is a potent BCR-ABL inhibitor effective in chronic myeloid leukemia and Ph(+) acute lymphoblastic leukemia (ALL) resistant/intolerant to imatinib. In the GIMEMA LAL1205 protocol, patients with newly diagnosed Ph(+) ALL older than 18 years (with no upper age limit) received dasatinib induction therapy for 84 days combined with steroids for the first 32 days and intrathecal chemotherapy. Postremission therapy was free. Fifty-three patients were evaluable (median age, 53.6 years). All patients achieved a complete hematologic remission (CHR), 49 (92...
December 15, 2011: Blood
Roberto Latagliata, Massimo Breccia, Paola Fazi, Marco Vignetti, Francesco Di Raimondo, Marco Sborgia, Donatella Vincelli, Anna Candoni, Flavia Salvi, Serena Rupoli, Giovanni Martinelli, Maria Grazia Kropp, Anna Tonso, Adriano Venditti, Lorella Melillo, Giuseppe Cimino, Maria Concetta Petti, Giuseppe Avvisati, Francesco Lo-Coco, Franco Mandelli
To reduce toxicity in elderly patients with acute promyelocytic leukaemia, in 1997 the Gruppo Italiano Malattie Ematologiche Dell'Adulto (GIMEMA) started an amended protocol for patients aged >60years, with the same induction [all-trans retinoic acid (ATRA)+idarubicin] as in younger patients, followed by a single consolidation course (idarubicin+ cytarabine) and maintenance with intermittent ATRA. Among 60 enrolled patients, 54 (90%) achieved haematological remission and six died during induction. Four additional patients died in complete remission (CR) from haemorrhage (2) and infection (2) prior or during consolidation therapy...
September 2011: British Journal of Haematology
Gabriele Gugliotta, Fausto Castagnetti, Francesca Palandri, Massimo Breccia, Tamara Intermesoli, Adele Capucci, Bruno Martino, Patrizia Pregno, Serena Rupoli, Dario Ferrero, Filippo Gherlinzoni, Enrico Montefusco, Monica Bocchia, Mario Tiribelli, Ivana Pierri, Federica Grifoni, Giulia Marzocchi, Marilina Amabile, Nicoletta Testoni, Giovanni Martinelli, Giuliana Alimena, Fabrizio Pane, Giuseppe Saglio, Michele Baccarani, Gianantonio Rosti et al.
The median age of chronic myeloid leukemia (CML) patients is ~60 years, and age is still considered an important prognostic factor, included in Sokal and EURO risk scores. However, few data are available about the long-term outcome of older patients treated with imatinib (IM) frontline. We analyzed the relationship between age and outcome in 559 early chronic-phase CML patients enrolled in 3 prospective clinical trials of Gruppo Italiano Malattie Ematologiche dell'Adulto CML Working Party, treated frontline with IM, with a median follow-up of 60 months...
May 26, 2011: Blood
F Efficace, K Cocks, M Breccia, M Sprangers, C A Meyers, M Vignetti, M Baccarani, F Mandelli
Health-related quality of life (HRQOL) and other patient-reported outcomes (PROs) might be crucial in comparing effectiveness of treatments as they could provide invaluable information to better inform clinical decision-making. This is particularly true in the era of targeted therapies (TT). A systematic review was undertaken on all studies with CML patients published from 1980 to 2010 and including a PRO evaluation. Out of 619 articles scrutinized, 15 met eligibility criteria and no study was published before 1995...
February 2012: Critical Reviews in Oncology/hematology
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