chronic myeloid leukemia
Conditions
Interventions
Discontinuation of treatment with tyrosine kinase inhibitors (TKI)(imatinib, nilotinib, dasatinib, bosutinib) in 50 patients with chronic myeloid leukemia that achieved a sustained deep molecular resp
the current dose of TKI will be reduced for 6 months before treatment discontinuation, for all participants. There is no control group.
Other
E02.760.952
HP3.095
Sponsors
Centro de Hematologia e Hemoterapia, Universidade Estadual de Campinas
Centro de Hematologia e Hemoterapia, Universidade Estadual de Campinas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with chronic CML; 18 years or older (WHO 2008); treated with TKI for more than 3 years; who have already had a complete cytogenetic response; typical BCR-ABL transcripts (b3a2 and / or b2a2) Patients with an RM4.5 response (PCR less or equal to 0.032%) sustained for 2 years. The patient must have 4 PCR tests in this period, confirming these results, 2 in the last 6 months.Mandatory use of contraceptive methods for women of childbearing age
Exclusion criteria
Exclusion criteria: Accelerated or previous blast phase; previous bone marrow transplant; resistance-related BCR-ABL1 mutations; BCR-ABL1 transcripts not measurable by quantitative PCR (unknown initial transcripts; atypical transcripts, such as p190 and others).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - treatment-free survival 12 months after discontinuation of tyrosine kinase inhibitor treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - to evaluate the proportion of patients with a higher molecular response (RMM) and deep molecular response (RM4.0 and RM4.5) at 3, 6 and 12 months after discontinuation ;- to assess the time between discontinuation and loss of MRI and/or complete cytogenetic response;- to identify clinical and laboratory factors related to the longer duration of molecular responses after discontinuation;- Determination of the kinetics of BCR-ABL1 transcripts in cases of relapse and who restart treatment with ITQ. In such cases, the identification of factors correlated with restoration of major molecular respo;- Assessment of overall survival, progression-free, and event-free of the study population;- to assess the cost-effectiveness of implementing discontinuation protocols in the context of SUS;- to assess the safety of the implementation of discontinuation protocols in the context of SUS;- to assess the quality of life of the implementation of discontinuation protocols in the context of SUS | — |
Countries
Brazil
Contacts
Public ContactKatia Pagnano
Centro Centro de Hematologia e Hemoterapia, Universidade Estadual de Campinas
Outcome results
None listed