Elisabetta Abruzzese, MD Principal Investigator Ospedale S. Eugenio Roma Vincenzo Accurso, MD Principal Investigator A.U. Policlinico "Paolo Giaccone" Palermo Mario Annunziata, MD Principal Investigator Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Napoli Francesco Passamonti, MD Principal Investigator Ospedale di Circolo e Fondazione Macchi Varese, ASST dei Sette Laghi Varese Massimo Bonifacio, MD Principal Investigator Istituti Ospitalieri di Verona- Policlinico G.B. Rossi Verona Giovanni Caocci, MD Principal Investigator CTMO - Ospedale "Businco" Cagliari Francesca Lunghi, MD Principal Investigator Ospedale Milano S. Raffaele Milano Chiara Elena, MD Principal Investigator Fondazione IRCCS Policlinico San Matteo di Pavia Monica Crugnola, MD Principal Investigator Az Ospedaliera Universitaria Parma Sara Galimberti, MD Principal Investigator Azienda Ospedaliera Pisana Pisa Alessandra Iurlo, MD Principal Investigator Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Milano Luciano Levato, MD Principal Investigator Az. Ospedaliera Pugliese - Ciaccio (AOPC) Catanzaro Maria Cristina Miggiano, MD Principal Investigator Azienda ULSS 8 "Berica" Ospedale San Bortolo Vicenza Patrizia Pregno, MD Principal Investigator A.O. Città della Salute e della Scienza di Torino S. G.Battista Torino Davide Rapezzi, MD Principal Investigator Ospedale Cuneo Rosaria Sancetta, MD Principal Investigator Ospedale dell'Angelo Mestre Venezia Fabio Stagno, MD Principal Investigator P.O. Gaspare Rodolico, Catania Luigia Luciano, MD Principal Investigator Azienda Ospedaliera Universitaria-Università degli Studi di Napoli "Federico II" Carmen Fava, MD Principal Investigator A.S.O. Ordine Mauriziano, P.O. Umberto I Torino Philipp leCoutre, MD Principal Investigator Charité University of Berlin · Medical Department, Division of Oncology and Hematology Susanne Saussele, MD Principal Investigator University of Mannheim Sarit Assouline, MD Principal Investigator Jewish General Hospital Alberto Álvarez-Larrán, MD Principal Investigator University Hospital Clínic de Barcelona
Charité University of Berlin - Clinic of Medicine - Hematology and Oncology 13353 Berlin (Berlin) GermanyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Philipp le Coutre, MD Phone: +49 30 450553077 E-Mail: philipp.lecoutre@charite.de» Ansprechpartner anzeigenUniversity of Mannheim, Mannheim, Germania Mannheim (Baden-Württemberg) GermanyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Susanne Saussele» Ansprechpartner anzeigenMcGill University - Jewish General Hospital Division of Hematology and Department of Oncology H3T 1E2 Montréal CanadaNoch nicht rekrutierend» Google-Maps Ansprechpartner: Sarit Assouline, MD Phone: 001 514 3408207 E-Mail: sarit.assouline@mcgill.ca» Ansprechpartner anzeigen
ASST-Monza 20900 Monza ItalyRekrutierend» Google-Maps Ansprechpartner: Carlo Gambacorti-Passerini, MD Phone: +390392339553 E-Mail: carlo.gambacorti@unimib.it» Ansprechpartner anzeigenFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC di Ematologia 20162 Milano ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Alessandra Iurlo Phone: +390255033362 E-Mail: aiurlo@policlinico.mi.it» Ansprechpartner anzeigenUniversita di Tor Vergata Ospedale S. Eugenio 00142 Rome ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Elisabetta Abruzzese E-Mail: elisabetta.abruzzese@uniroma2.it» Ansprechpartner anzeigenIstituto di Ematologia "Lorenzo e A. Seragnoli" Policlinico S. Orsola Malpighi, Bologna ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Gianantonio Rosti» Ansprechpartner anzeigenCTMO Ematologia Ospedale "Businco" Cagliari ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Giovanni Caocci» Ansprechpartner anzeigenUniversità di Catania Cattedra di Ematologia Ospedale "Ferrarotto" Catania ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Fabio Stagno» Ansprechpartner anzeigenSOC Ematologia Az. Ospedaliera Pugliese Ciaccio (AOPC) Catanzaro ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Luciano Levato» Ansprechpartner anzeigenEmatologia Ospedale Cuneo Cuneo ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Davide Rapezzi» Ansprechpartner anzeigenUO Ematologia O spedale Milano S. Raffaele Miano ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Francesca Lunghi» Ansprechpartner anzeigenAzienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Napoli ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Mario Annunziata» Ansprechpartner anzeigenAzienda Ospedaliera Universitaria Università degli Studi di Napoli "Federico II" Facoltà di Medicina e Chirurgia Napoli ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Luigia Luciani» Ansprechpartner anzeigenU.O. di Ematologia con trapianto A.U. Policlinico "Paolo Giaccone" Palermo ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Vincenzo Accurso» Ansprechpartner anzeigenUnità operativa Ematologia e CTMO Az Ospedaliera Universitaria Parma ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Monica Crugnola» Ansprechpartner anzeigenFondazione IRCCS Policlinico San Matteo Pavia ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Chiara Elena» Ansprechpartner anzeigenUniversità di Pisa Azienda Ospedaliera Pisana Divisione di Ematologia Pisa ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Sara Galimberti» Ansprechpartner anzeigenAzienda Unità Sanitaria Locale IRCCS Reggio Emilia ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Isabella Capodanno» Ansprechpartner anzeigenDipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino S. G.Battista Torino ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Patrizia Pregno» Ansprechpartner anzeigenStruttura Complessa a Dir. Universitaria Ematologia e Terapie Cellulari A.S.O. Ordine Mauriziano, P.O. U mberto I Torino ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Carmen Fava» Ansprechpartner anzeigenS.C. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese, ASST dei Sette Laghi, Varese ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Francesco Passamonti» Ansprechpartner anzeigenU.O. di Ematologia Ospedale dell'Angelo Mestre Venezia ItalyRekrutierend» Google-Maps Ansprechpartner: Rosaria Sancetta» Ansprechpartner anzeigenIstituti Ospitalieri di Verona Div. di Ematologia Policlinico G.B. Rossi Verona ItalyNoch nicht rekrutierend» Google-Maps Ansprechpartner: Massimo Bonifacio» Ansprechpartner anzeigenU.O. Complessa di Ematologia Azienda ULSS 8 "Berica" Ospedale San Bortolo Vicenza ItalyRekrutierend» Google-Maps Ansprechpartner: Maria Cristina Miggiano» Ansprechpartner anzeigenUniversity Hospital Clínic de Barcelona Barcelona SpainNoch nicht rekrutierend» Google-Maps Ansprechpartner: Alberto Alvarez-Larràn» Ansprechpartner anzeigen
1. The quantification of the risk of progression (Time Frame - 36 Month): To quantify the risk of progression to accelerated phase (AP) or blast phase (BP), expressed as time adjusted rate (TAR), after TKI discontinuation in CML patients who undergo a first or subsequent TKI discontinuation attempt
Secondary outcome:
1. To compare the time adjusted rate (TAR) of progression from Chronic phase-Chronic Myeloid Leukemia to Accelerated phase (AP) or Blastic phase (BP) by using the percentage of blasts, promyelocytes, basophils or platelet in blood or bone marrow (Time Frame - 36 Month): To compare the TAR (time adjusted rate) of progression to AP or BP that is obtained in the target population to that obtained in a similar population of patients with the same characteristics who do not discontinue TKI treatment
2. Progression free survival (PFS) after TKI discontinuation. (Time Frame - 36 Month): PFS will be defined as time between discontinuation and progression to AP or BP.
3. Rate of molecular relapse (loss of MR3 or MMR) (Time Frame - 36 Month): Rate of molecular relapse (loss of MR3 or MMR) at 12 and 24 months after TKI discontinuation.
4. Relapse free survival (RFS) after TKI discontinuation. (Time Frame - 36 Month): Relapse free survival (RFS) after TKI discontinuation. RFS will be defined as time between discontinuation and loss of MMR (i.e. molecular relapse).
5. Percentage of relapsed patients who obtain a new deep molecular response (DMR) within 6-12 months of treatment resumption among all patients who restart TKI treatment because of a molecular relapse after TKI discontinuation. (Time Frame - 36 Month): The following criteria will be used to define DMR (43):
MR4 = either (i) detectable disease with <0.01% BCR-ABL1IS or (ii) undetectable disease in cDNA with >10 000 ABL1 transcripts.
MR4.5 = either (i) detectable disease with <0.0032% BCR-ABL1IS or (ii) undetectable disease in cDNA with >32 000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1.
MR5 = either (i) detectable disease with <0.001% BCR-ABL1IS or (ii) undetectable disease in cDNA with >100 000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1.
Retrospective cohort Patients who discontinued before the opening of this study will contribute to the retrospective cohort.
Prospective cohort Patients who will discontinue after it will contribute to the prospective cohort.
Retrospective/Prospective cohort Patients who discontinued before the opening of this study but will continue their discontinuation after it, will contribute to both cohorts.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation"
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