- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02810990
Bosutinib in Elderly Chronic Myeloid Leukemia (BEST)
Bosutinib Efficacy, Safety, Tolerability (BEST) Study in Elderly Chronic Myeloid Leukemia Patients Failing Front-line Treatment With Other Tyrosine Kinase Inhibitors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alessandria, Italy
- S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
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Ancona, Italy
- Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
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Bari, Italy
- UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
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Bologna, Italy
- Fausto Castagnetti
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Bologna, Italy
- Istituto di Ematologia "Lorenzo e A. Seragnoli" - Policlinico S. Orsola - Malpighi
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Cagliari, Italy
- ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
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Catania, Italy
- Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
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Cuneo, Italy
- S.C. Ematologia ASO S. Croce e Carle
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Ferrara, Italy
- Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia
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Firenze, Italy
- Policlinico di Careggi
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Foggia, Italy
- Struttura Complessa di Ematologia Ospedali Riuniti Foggia
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Genova, Italy
- IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
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Lecce, Italy
- ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
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Meldola, Italy
- Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
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Messina, Italy
- Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
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Milano, Italy
- U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
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Milano, Italy
- Unità Trapianto di Midollo Ist. Nazionale Tumori
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Milano, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia
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Monza, Italy
- Azienda Ospedaliera "S.Gerardo"
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Napoli, Italy
- Azienda Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
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Novara, Italy
- S.C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro
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Orbassano, Italy
- Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
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Padova, Italy
- Università degli Studi di Padova - Ematologia ed Immunologia Clinica
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Palermo, Italy
- U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"
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Parma, Italy
- Cattedra di Ematologia CTMO Università degli Studi di Parma
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Pavia, Italy
- S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
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Piacenza, Italy
- Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
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Potenza, Italy
- Ematologia - Ospedale San Carlo
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Ravenna, Italy
- Dipartimento Oncologico - Ospedale S.Maria delle Croci
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Reggio Emilia, Italy
- Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
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Rimini, Italy
- Ospedale "Infermi"
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Rionero in Vulture, Italy
- U.O. di Ematologia - Centro Oncologico Basilicata
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Roma, Italy
- Complesso Ospedaliero S. Giovanni Addolorata
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Roma, Italy
- Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
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Roma, Italy
- Divisione Ematologia - Università Campus Bio-Medico
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Roma, Italy
- Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo
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Roma, Italy
- UOC Pronto Soccorso - Dipartimento Biotecnologie Cellulari Università di Roma "Sapienza"
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San Giovanni Rotondo, Italy
- Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
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Siena, Italy
- U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
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Terni, Italy
- A.O. Santa Maria - Terni S.C Oncoematologia
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Torino, Italy
- Divisione di Ematologia - "Città della Salute e della Scienza di Torino"
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Torino, Italy
- S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
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Udine, Italy
- Clinica Ematologica-Centro Trapianti e Terapie cellulari
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Varese, Italy
- Medicina Interna I - Ospedale di Circolo
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Verona, Italy
- A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Molecular confirmed diagnosis of BCR-ABL1+ CML
- Chronic phase CML (ELN 2013 criteria)
- 60 years of age or older
- Prior first-line treatment with any other TKIs
Intolerance to prior treatment, based on investigator and patient assessment or failure of prior treatment according to any one of the ELN 2013 criteria, as listed below
- Non complete hematologic response (CHR) at 3 months
- No cytogenetic response (Ph+ > 95%) at 6 months
- Less than Partial Cytogenetic Response (PCyR) (Ph+ >35%) at 6 months
- BCR-ABL1 > 10% at 6 months
- Non complete CyR (CCyR) (Ph+ > 0) at 12 months
- BCR-ABL1 > 1% at 12 months
- Loss of CHR at any time
- Loss of CCyR at any time
- Confirmed loss of major molecular response (MMR) (BCR-ABL1 > 0.1%) in two consecutive tests, of which one > 1%, at any time
- An effective form of contraception from enrolment through 30 days after the end of treatment
- Signed written informed consent according to ICH/EU/GCP and national and local laws prior to any study procedures
- Willingness and ability to comply with scheduled visits and study procedures.
Exclusion Criteria:
- Accelerated or blastic phase CML (according to ELN 2013 criteria)
- Patients with the T315I or the V299L mutation
- Patients previously treated with 2 TKIs or more
- Compelled to take medications that are known to be associated with Torsades de Pointes and/or with significant QTc prolongation
- Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug
- HBV markers positivity
- Lack of informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bosutinib treatment
|
Bosutinib is given orally accordingly with this scheme: A. 200 mg OD: starting dose ("wash-in" period) at week 1 and week 2 B. 300 mg OD: from week 3 to the end of week 16 At the end of week 12 evaluation of molecular response (BCR-ABL1 level by RT-Q-PCR). Bosutinib dose is then managed as follows : C1. if BCR-ABL1 ≤1% at week 12: 300 mg OD from week 17 to week 52 C2. if BCR-ABL1 > 1% at week 12: 400 mg OD from week 17 to week 52 All the responsive patients who are still on Bosutinib at the end of week 52, will continue Bosutinib at the same dose (300 mg OD or 400 mg OD) for the next two years ( if tolerated and in absence of safety concerns). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who are in major molecular response (MMR)
Time Frame: One year treatment
|
One year treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients who obtain molecular response
Time Frame: At 6 and 12 months from treatment start
|
At 6 and 12 months from treatment start
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Number of patients discontinuing treatment for failure, adverse events or other reasons
Time Frame: At 12 and 36 months
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At 12 and 36 months
|
Number of Adverse Events (AEs)
Time Frame: At 36 months
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At 36 months
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Number of patients alive
Time Frame: At 36 months
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At 36 months
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Number of patients on treatment at 200, 300 and 400 mg or more daily
Time Frame: At 6, 12 and 36 months
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At 6, 12 and 36 months
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Number and type of BCR-ABL1 mutations
Time Frame: At 36 months
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At 36 months
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Patient reported quality of life
Time Frame: At 3, 6, and 12 months
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At 3, 6, and 12 months
|
Collaborators and Investigators
Investigators
- Study Chair: Fausto Castagnetti, Department of Hematology, S. Orsola-Malpighi University of Bologna
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CML1516
- 2016-002216-40 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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