Study of Imatinib Discontinuation in Chronic Myeloid Leukemia With Deep Molecular Response

Launched by UNIVERSITY OF CAMPINAS, BRAZIL · Jul 28, 2016

Keywords

ClinConnect Summary

Treatment of chronic myeloid leucemia (CML) with tyrosine kinase inhibitors (TKIs) changed dramatically the prognosis of CML, with high rates of cytogenetic and molecular remission and increase of overall and progression-free survival. However, the long-term treatment of CML has a high cost to the health system, due to the price of these drugs and the need for continued use. In addition, chronic adverse effects may compromise the quality of life of patients. Discontinuation trials of TKIs have been developed in order to identify groups of patients who may benefit from treatment discontinuat...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • CML in chronic phase
• • treatment with imatinib for 3 or more years
• • MR4.5 (RQ-PCR\< ou =0.0032%) confirmed by 4 RQ-PCR tests for BCR-ABL in the last 2 years (2 tests within the last 6 months)
• • Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
• • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 reference level
• • Bilirubins ≤ 1.5 reference level
• • Contraceptive precautions for women
• Exclusion Criteria:
• • Patients less than 18 years
• • Severe organ disfunction (liver or kidney)
• • Severe cardiovascular disease: grade I-IV from New York Heart Association (NYHA) or acute myocardial infarction in the last six months, symptomatic arrhythmias
• • Fluid retention grade 3 or 4
• • Osteoporosis in treatment
• • Patients with previous CML in accelerated or blast phase or blast or Philadelphia positive (Ph+) acute lymphoid leukemia (ALL)
• • BCR-ABL mutations related to resistance
• • Previous allogeneic bone marrow transplantation