Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chroni… (NCT03817398) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia
United States, Australia, Canada110 participantsStarted 2019-11-08
Plain-language summary
This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.
Who can participate
Age range
25 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:
* Patient must have been diagnosed with CML-CP at \< 18 years of age.
* Patient must have histologic verification of CML-CP at original diagnosis
* Patient must be in molecular remission (MR) with a BCR-ABL1 level of =\< 0.01% BCR-ABL1 as measured using the International Scale (IS) by RQ-PCR for \>= 2 consecutive years at the time of enrollment
* Please note: The lab evaluating disease status and molecular response for this study must be College of American Pathology (CAP) and/or Clinical Laboratory Improvement Amendments (CLIA) certified (United States \[US\] only), sites in other countries must be certified by their accredited authorities. All labs must use the International Scale guidelines with a sensitivity of detection assay =\< 0.01% BCR-ABL1 and be able to report results in =\< 2 weeks
* Patient must have received any TKI for a minimum of 3 consecutive years at time of enrollment
* Patient agrees to discontinue TKI therapy
* REGULATORY REQUIREMENTS
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
* ELIGIBILITY FOR PATIENT-REPORTED OUTCOMES (PROs):
* Age \>= 8 years at the time of enrollment
* Ability to understand English or Spanish
* Cognitive ability to complete instruments according to the primary team
* ELIGIBILITY FOR AAML18P1 NEUROCOGNITIVE STUDY:
* Patient must …
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
1
Treatment-free remission (TFR)
Timeframe: From date of TKI discontinuation to the date of the first event (molecular recurrence, hematologic relapse, cytogenetic relapse, re-initiation of TKI therapy, second malignant neoplasm, or death) or censoring, assessed up to 2 years