Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Signed and dated IRB/IEC-approved informed consent for the prospective cohort patients. 2. Age >= 18 years. 3. Male or female patients with CML diagnosed in chronic phase (CP). 4. At least 4 years of TKI treatment. 5. At least 18 months of DMR.

Exclusion Criteria:

- Allogeneic hematopoietic stem cell transplantation.

- CML diagnosed in AP or BC

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04621851
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Milano Bicocca
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Elisabetta Abruzzese, MDVincenzo Accurso, MDMario Annunziata, MDFrancesco Passamonti, MDMassimo Bonifacio, MDGiovanni Caocci, MDFrancesca Lunghi, MDChiara Elena, MDMonica Crugnola, MDSara Galimberti, MDAlessandra Iurlo, MDLuciano Levato, MDMaria Cristina Miggiano, MDPatrizia Pregno, MDDavide Rapezzi, MDRosaria Sancetta, MDFabio Stagno, MDLuigia Luciano, MDCarmen Fava, MDPhilipp leCoutre, MDSusanne Saussele, MDSarit Assouline, MDAlberto Álvarez-Larrán, MD
Principal Investigator Affiliation	Ospedale S. Eugenio RomaA.U. Policlinico "Paolo Giaccone" PalermoAzienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" NapoliOspedale di Circolo e Fondazione Macchi Varese, ASST dei Sette Laghi VareseIstituti Ospitalieri di Verona- Policlinico G.B. Rossi VeronaCTMO - Ospedale "Businco" CagliariOspedale Milano S. Raffaele MilanoFondazione IRCCS Policlinico San Matteo di PaviaAz Ospedaliera Universitaria ParmaAzienda Ospedaliera Pisana PisaFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano MilanoAz. Ospedaliera Pugliese - Ciaccio (AOPC) CatanzaroAzienda ULSS 8 "Berica" Ospedale San Bortolo VicenzaA.O. Città della Salute e della Scienza di Torino S. G.Battista TorinoOspedale CuneoOspedale dell'Angelo Mestre VeneziaP.O. Gaspare Rodolico, CataniaAzienda Ospedaliera Universitaria-Università degli Studi di Napoli "Federico II"A.S.O. Ordine Mauriziano, P.O. Umberto I TorinoCharité University of Berlin · Medical Department, Division of Oncology and HematologyUniversity of MannheimJewish General HospitalUniversity Hospital Clínic de Barcelona
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada, Germany, Italy, Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Myeloid Leukemia

Additional Details

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. .

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Montréal, Quebec, Canada

Status

Not yet recruiting

Address

McGill University - Jewish General Hospital Division of Hematology and Department of Oncology

Montréal, Quebec, H3T 1E2

Site Contact

Sarit Assouline, MD

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