Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Myeloid Leukemia
- Design
- Observational Model: CohortTime Perspective: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 de...
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. .
Tracking Information
- NCT #
- NCT04621851
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Elisabetta Abruzzese, MD Ospedale S. Eugenio Roma Principal Investigator: Vincenzo Accurso, MD A.U. Policlinico "Paolo Giaccone" Palermo Principal Investigator: Mario Annunziata, MD Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Napoli Principal Investigator: Francesco Passamonti, MD Ospedale di Circolo e Fondazione Macchi Varese, ASST dei Sette Laghi Varese Principal Investigator: Massimo Bonifacio, MD Istituti Ospitalieri di Verona- Policlinico G.B. Rossi Verona Principal Investigator: Giovanni Caocci, MD CTMO - Ospedale "Businco" Cagliari Principal Investigator: Francesca Lunghi, MD Ospedale Milano S. Raffaele Milano Principal Investigator: Chiara Elena, MD Fondazione IRCCS Policlinico San Matteo di Pavia Principal Investigator: Monica Crugnola, MD Az Ospedaliera Universitaria Parma Principal Investigator: Sara Galimberti, MD Azienda Ospedaliera Pisana Pisa Principal Investigator: Alessandra Iurlo, MD Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano Milano Principal Investigator: Luciano Levato, MD Az. Ospedaliera Pugliese - Ciaccio (AOPC) Catanzaro Principal Investigator: Maria Cristina Miggiano, MD Azienda ULSS 8 "Berica" Ospedale San Bortolo Vicenza Principal Investigator: Patrizia Pregno, MD A.O. Città della Salute e della Scienza di Torino S. G.Battista Torino Principal Investigator: Davide Rapezzi, MD Ospedale Cuneo Principal Investigator: Rosaria Sancetta, MD Ospedale dell'Angelo Mestre Venezia Principal Investigator: Fabio Stagno, MD P.O. Gaspare Rodolico, Catania Principal Investigator: Luigia Luciano, MD Azienda Ospedaliera Universitaria-Università degli Studi di Napoli "Federico II" Principal Investigator: Carmen Fava, MD A.S.O. Ordine Mauriziano, P.O. Umberto I Torino Principal Investigator: Philipp leCoutre, MD Charité University of Berlin · Medical Department, Division of Oncology and Hematology Principal Investigator: Susanne Saussele, MD University of Mannheim Principal Investigator: Sarit Assouline, MD Jewish General Hospital Principal Investigator: Alberto Álvarez-Larrán, MD University Hospital Clínic de Barcelona
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