Bosutinib in Elderly Chronic Myeloid Leukemia (BEST)
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ClinicalTrials.gov Identifier: NCT02810990 |
Recruitment Status :
Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : January 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Myeloid Leukemia | Drug: Bosutinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 65 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Bosutinib Efficacy, Safety, Tolerability (BEST) Study in Elderly Chronic Myeloid Leukemia Patients Failing Front-line Treatment With Other Tyrosine Kinase Inhibitors |
Actual Study Start Date : | November 17, 2016 |
Actual Primary Completion Date : | April 30, 2020 |
Estimated Study Completion Date : | April 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Bosutinib treatment |
Drug: Bosutinib
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). |
- Number of patients who are in major molecular response (MMR) [ Time Frame: One year treatment ]
- Number of patients who obtain molecular response [ Time Frame: At 6 and 12 months from treatment start ]
- Number of patients discontinuing treatment for failure, adverse events or other reasons [ Time Frame: At 12 and 36 months ]
- Number of Adverse Events (AEs) [ Time Frame: At 36 months ]
- Number of patients alive [ Time Frame: At 36 months ]
- Number of patients on treatment at 200, 300 and 400 mg or more daily [ Time Frame: At 6, 12 and 36 months ]
- Number and type of BCR-ABL1 mutations [ Time Frame: At 36 months ]
- Patient reported quality of life [ Time Frame: At 3, 6, and 12 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810990

Study Chair: | Fausto Castagnetti | Department of Hematology, S. Orsola-Malpighi University of Bologna |
Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
ClinicalTrials.gov Identifier: | NCT02810990 |
Other Study ID Numbers: |
CML1516 2016-002216-40 ( EudraCT Number ) |
First Posted: | June 23, 2016 Key Record Dates |
Last Update Posted: | January 5, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
bosutinib chronic myeloid leukemia |
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |