NCT02852486CompletedPhase 2
Study of Imatinib Discontinuation in Chronic Myeloid Leukemia With Deep Molecular Response
Pilot Study of Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia With Deep Molecular Response - Evaluation of Pioglitazone in Treatment-free Remission (EDI-PIO)
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 9 Jul 2016
- Start date
- 22 Jun 2016
- Primary completion date
- 7 Feb 2024
- Lead sponsor
- University of Campinas, Brazil
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT02852486
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 31
- From 22 Jun 2016 to the primary completion date, 7 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous CML in accelerated or blast phase or blast or Philadelphia positive (Ph+) acute lymphoid leukemia (ALL)
- Previous allogeneic bone marrow transplantation
Other illness
- Severe cardiovascular disease: grade I-IV from New York Heart Association (NYHA) or acute myocardial infarction in the last six months, symptomatic arrhythmias
Other
- Patients less than 18 years
- Severe organ disfunction (liver or kidney)
- Fluid retention grade 3 or 4
- Osteoporosis in treatment
- BCR-ABL mutations related to resistance
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Hematologia e Hemoterapia - Universidade Estadual de Campinas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.