A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia (NCT03874858) | Clinical Trial Compass
TerminatedPhase 2
A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia
Stopped: Sponsor decision: The primary endpoint of the core/TF1 was achieved, and the sample size of Extension/TFR2 was unlikely to yield meaningful results. No new safety signals were observed. For these reasons, continuing the study was not justified.
Italy135 participantsStarted 2019-03-22
Plain-language summary
This study is constituted of two stage: Treatment-Free Remission 1 (TFR1) stage and Treatment-Free Remission 2 (TFR2) stage.
The purpose of the TFR1 stage is to assess the effect of nilotinib reduced to half the standard dose for 12 months on treatment-free remission in patients with Chronic Myeloid Leukemia - Chronic Phase (CML-CP) treated with first-line nilotinib who reached a sustained deep molecular response before entering the study.
The purpose of the TFR2 stage is to evaluate whether the use of asciminib in combination with nilotinib after failure of a first attempt at TFR can lead to higher and more durable TFR rates after a second attempt at TKI discontinuation than those reported in other studies.
Who can participate
Age range
18 Years – 99 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
. Male and female patients 18 years or older.
. Diagnosis of CML-CP according to the World Health Organization (WHO).
. Patients with CML-CP under first-line treatment with nilotinib at the approved daily dose of 300 mg BID mg for at least 3 calendar years.
. Sustained DMR defined as ≥ MR 4.0 (BCR-ABL level ≤0.01% IS) in all of the last 4 BCR-ABL RQ-PCR assessments with a minimum interval between each assessment of 3 months and a maximum interval of 6 months.
. Patient must meet the following laboratory values at the screening visit:
. Eastern Cooperative Oncology Group performance status (ECOG) 0-2.
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
Percentage of patients in full treatment-free remission 96 weeks after the start of the consolidation period of TFR1 stage
Timeframe: Baseline of consolidation phase up to 96 weeks of TFR1 stage
2
Percentage of patients in treatment-free remission 48 weeks after starting a second attempt at treatment-free remission during TFR2 stage.
Timeframe: Baseline TFR2 phase (week 96 of TFR2 stage) up to week 144 of TFR2 stage
. Study subjects must be able to comply with study procedures and follow-up examinations.
. Signed informed consent to the TFR1 stage from the patient or from his/her legal representative.
Exclusion criteria
. Patients with known atypical transcript.
. CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if testing was done in the past (there is no requirement to perform mutation testing at study entry if it was not done in the past).
. Dose reductions/interruptions due to neutropenia or thrombocytopenia in the past 6 months.
. Patient ever attempted to permanently discontinue nilotinib treatment.
. Known impaired cardiac function including any one of the following:
. Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
. History of acute pancreatitis within 1 year prior to study entry or past medical history of chronic pancreatitis.
. Known presence of a significant congenital or acquired bleeding disorder unrelated to cancer.