CompletedPhase 2

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

Brazil31 participantsStarted 2016-06-22

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment-free remission after imatinib discontinuation

Timeframe: Through study completion (five years)

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: 3 months

Trial details

NCT IDNCT02852486

SponsorUniversity of Campinas, Brazil

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-07

View on ClinicalTrials.gov More Leukemia, Chronic Myeloid trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.