Bosutinib in Elderly Chronic Myeloid Leukemia

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the present study is to evaluate a new drug called bosutinib as it is believed that this agent may be able to predict an excellent prognosis in patients that did not obtain any benefit with other drugs before. Still, this needs to be proved and we hope this study is able to do so.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Criteria

Inclusion Criteria:

1. Molecular confirmed diagnosis of BCR-ABL1+ CML

2. Chronic phase CML (ELN 2013 criteria)

3. 60 years of age or older

4. Prior first-line treatment with any other TKIs

5. 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

6. An effective form of contraception from enrolment through 30 days after the end of treatment

7. Signed written informed consent according to ICH/EU/GCP and national and local laws prior to any study procedures

8. Willingness and ability to comply with scheduled visits and study procedures.

Exclusion Criteria:

1. Accelerated or blastic phase CML (according to ELN 2013 criteria)

2. Patients with the T315I or the V299L mutation

3. Patients previously treated with 2 TKIs or more

4. Compelled to take medications that are known to be associated with Torsades de Pointes and/or with significant QTc prolongation

5. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug

6. HBV markers positivity

7. Lack of informed consent