Efficacy, safety and tolerability of a drug called Bosutinib, in eldery patients affected by Chronic Myeloid Leukemia failing front-line treatment with other drugs with similar features.

Phase 1

• Conditions: Chronic Myeloid Leukemia (CML) in Chronic Phase; MedDRA version: 21.1Level: PTClassification code 10009013Term: Chronic myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-002216-40-IT
• Lead Sponsor: FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1.Molecular confirmed diagnosis of BCR-ABL1+ CML
2.Chronic phase CML (ELN 2013 criteria)
3.Age greater than or equal to 60 years
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 3 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
• New BCR-ABL1 Mutations at any time
• New Clonal Chromosomal Abnormalities in Ph+ cells (clonal evolution) 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

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 or more TKIs
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified