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

• Status: Active, not recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate treatment-free remission after imatinib discontinuation in patients with chronic myeloid leukemia with deep molecular response. Before discontinuation, patients will receive pioglitazone associated with imatinib during 3 months.

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

Details

• Lead Sponsor: University of Campinas, Brazil
• Treatments: Imatinib Mesylate; Pioglitazone

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