Spots Global Cancer Trial Database for Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
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Trial Identification
Brief Title: Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
Official Title: Retro-prospective Observational Study on Risk of Progression in Chronic Phase-Chronic Myeloid Leukemia Patients Eligible for Tyrosine Kinase Inhibitor Discontinuation (TFR - PRO)
Study ID: NCT04621851
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to investigate the safety profile of TKI discontinuation in clinical practice, with particular regard on the risk of progression after treatment discontinuation.
Detailed Description: This study will enroll approximately 3000 CP-CML patients that must have a history of at least 4 years of TKI treatment and at least 18 months of DMR. Events developing in patients after the end of discontinuation and TKI resumption will be considered as linked to the discontinuation if they will develop within 36 months from the end of discontinuation. This rule will apply also to subsequent TD attempts. In case of a second or subsequent discontinuation attempt after the failure of a previous one (for molecular relapse), patients must have re-achieved a DMR with TKI therapy resumption and must keep DMR for at least 18 months before another TD. Collection of data will be retrospective and prospective, as each center will collect the data for 24 months. Patients who discontinued before the opening of this study will contribute to the retrospective cohort, while those who will discontinue after it will contribute to the prospective cohort. Patients who discontinued before the opening of this study but will continue their discontinuation after it, will contribute to both cohorts. For patients prospectively recruited, monitoring of disease status will be performed to assess the maintenance of the molecular remission during the study period. Patients with an atypical BCR-ABL1 fusion gene, which does not allow the use of Q-RT-PCR, will be monitored by qualitative PCR and will be analyzed separately. For these patients, negativity of nested qualitative RT-PCR will be considered a surrogate of DMR of patients monitored by Q-RT-PCR, while loss of negativity of first-round qualitative PCR will be considered a surrogate of loss of MMR (i.e. molecular relapse). Accordingly, for patients monitored by qualitative PCR, TKI resumption after TD will be provided in case of a new positivity of first-round PCR. .
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
McGill University - Jewish General Hospital Division of Hematology and Department of Oncology, Montréal, Quebec, Canada
Charité University of Berlin - Clinic of Medicine - Hematology and Oncology, Berlin, , Germany
University of Mannheim, Mannheim, Germania, Mannheim, , Germany
ASST-Monza, Monza, Italy/MB, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC di Ematologia, Milano, Italy/Milano, Italy
Universita di Tor Vergata Ospedale S. Eugenio, Rome, Italy/Rome, Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" Policlinico S. Orsola Malpighi,, Bologna, , Italy
CTMO Ematologia Ospedale "Businco", Cagliari, , Italy
Università di Catania Cattedra di Ematologia Ospedale "Ferrarotto", Catania, , Italy
SOC Ematologia Az. Ospedaliera Pugliese Ciaccio (AOPC), Catanzaro, , Italy
Ematologia Ospedale Cuneo, Cuneo, , Italy
UO Ematologia O spedale Milano S. Raffaele, Miano, , Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli", Napoli, , Italy
Azienda Ospedaliera Universitaria Università degli Studi di Napoli "Federico II" Facoltà di Medicina e Chirurgia, Napoli, , Italy
U.O. di Ematologia con trapianto A.U. Policlinico "Paolo Giaccone", Palermo, , Italy
Unità operativa Ematologia e CTMO Az Ospedaliera Universitaria, Parma, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Università di Pisa Azienda Ospedaliera Pisana Divisione di Ematologia, Pisa, , Italy
Azienda Unità Sanitaria Locale IRCCS, Reggio Emilia, , Italy
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino S. G.Battista, Torino, , Italy
Struttura Complessa a Dir. Universitaria Ematologia e Terapie Cellulari A.S.O. Ordine Mauriziano, P.O. U mberto I, Torino, , Italy
S.C. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese, ASST dei Sette Laghi,, Varese, , Italy
U.O. di Ematologia Ospedale dell'Angelo Mestre, Venezia, , Italy
Istituti Ospitalieri di Verona Div. di Ematologia Policlinico G.B. Rossi, Verona, , Italy
U.O. Complessa di Ematologia Azienda ULSS 8 "Berica" Ospedale San Bortolo, Vicenza, , Italy
University Hospital Clínic de Barcelona, Barcelona, , Spain
Contact Details
Name: Elisabetta Abruzzese, MD
Affiliation: Ospedale S. Eugenio Roma
Role: PRINCIPAL_INVESTIGATOR
Name: Vincenzo Accurso, MD
Affiliation: A.U. Policlinico "Paolo Giaccone" Palermo
Role: PRINCIPAL_INVESTIGATOR
Name: Mario Annunziata, MD
Affiliation: Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Napoli
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Passamonti, MD
Affiliation: Ospedale di Circolo e Fondazione Macchi Varese, ASST dei Sette Laghi Varese
Role: PRINCIPAL_INVESTIGATOR
Name: Massimo Bonifacio, MD
Affiliation: Istituti Ospitalieri di Verona- Policlinico G.B. Rossi Verona
Role: PRINCIPAL_INVESTIGATOR
Name: Giovanni Caocci, MD
Affiliation: CTMO - Ospedale "Businco" Cagliari
Role: PRINCIPAL_INVESTIGATOR
Name: Francesca Lunghi, MD
Affiliation: Ospedale Milano S. Raffaele Milano
Role: PRINCIPAL_INVESTIGATOR
Name: Chiara Elena, MD
Affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
Role: PRINCIPAL_INVESTIGATOR
Name: Monica Crugnola, MD
Affiliation: Az Ospedaliera Universitaria Parma
Role: PRINCIPAL_INVESTIGATOR
Name: Sara Galimberti, MD
Affiliation: Azienda Ospedaliera Pisana Pisa
Role: PRINCIPAL_INVESTIGATOR
Name: Alessandra Iurlo, MD
Affiliation: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Milano
Role: PRINCIPAL_INVESTIGATOR
Name: Luciano Levato, MD
Affiliation: Az. Ospedaliera Pugliese - Ciaccio (AOPC) Catanzaro
Role: PRINCIPAL_INVESTIGATOR
Name: Maria Cristina Miggiano, MD
Affiliation: Azienda ULSS 8 "Berica" Ospedale San Bortolo Vicenza
Role: PRINCIPAL_INVESTIGATOR
Name: Patrizia Pregno, MD
Affiliation: A.O. Città della Salute e della Scienza di Torino S. G.Battista Torino
Role: PRINCIPAL_INVESTIGATOR
Name: Davide Rapezzi, MD
Affiliation: Ospedale Cuneo
Role: PRINCIPAL_INVESTIGATOR
Name: Rosaria Sancetta, MD
Affiliation: Ospedale dell'Angelo Mestre Venezia
Role: PRINCIPAL_INVESTIGATOR
Name: Fabio Stagno, MD
Affiliation: P.O. Gaspare Rodolico, Catania
Role: PRINCIPAL_INVESTIGATOR
Name: Luigia Luciano, MD
Affiliation: Azienda Ospedaliera Universitaria-Università degli Studi di Napoli "Federico II"
Role: PRINCIPAL_INVESTIGATOR
Name: Carmen Fava, MD
Affiliation: A.S.O. Ordine Mauriziano, P.O. Umberto I Torino
Role: PRINCIPAL_INVESTIGATOR
Name: Philipp leCoutre, MD
Affiliation: Charité University of Berlin · Medical Department, Division of Oncology and Hematology
Role: PRINCIPAL_INVESTIGATOR
Name: Susanne Saussele, MD
Affiliation: University of Mannheim
Role: PRINCIPAL_INVESTIGATOR
Name: Sarit Assouline, MD
Affiliation: Jewish General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Alberto Álvarez-Larrán, MD
Affiliation: University Hospital Clínic de Barcelona
Role: PRINCIPAL_INVESTIGATOR
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