Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients (NCT02201459) | Clinical Trial Compass
CompletedPhase 3
Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients
France200 participantsStarted 2014-08
Plain-language summary
This is a phase III trial comparing, for newly diagnosed chronic phase CML patients, nilotinib 600 mg BID as a standard arm and nilotinib 600 mg BID combined to interferon alfa 2 a (pegylated form improving tolerance and maybe enhancing is efficacy) at increased doses for a total of 24 months of combination, in a 1:1 randomized manner. The assessment for the primary efficacy endpoint will be performed at 12 months (since nilotinib initiation) and is the rate patients obtaining MR4.5 will be measured at this time point.
Who can participate
Age range
18 Years – 65 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
* CP-CML, positive Philadelphia chromosome or positive BCR-ABL (M-bcr transcript), diagnosed less than 3 months prior to study entry
* Age of at least 18 years-old and less than 65 years
* Patient for whom treatment with Nilotinib is expected
* No other CML treatment except for hydroxyurea and/or anagrelide
* No previous TKI treatment.
* No previous treatment with IFN even for other purposes.
* SGOT and SGPT \< 2.5 UNL
* Serum creatinine \< 2 UNL
* No planned allogeneic stem cell transplantation
* Signed informed consent
* ECOG score 0 to 2
Exclusion Criteria:
* Contra-indication to IFN
* Transcripts other than M-Bcr
* Pregnancy, lactation
* HIV positivity, chronic hepatitis B or C.
* Prior or concurrent malignancy other than CML (exceptions to be mentioned)
* History of arterial occlusive disease or (peripheral, carotids or severe coronary heart disease).
* Permanent elevation of total cholesterol and triglycerides despite treatment
* Severe psychiatric/neurological disease (previous or ongoing)
* Concomitant auto-immune disease
* Other investigational product ongoing
* Ongoing immunosuppressive treatment
* Ongoing treatment at risk for inducing torsades de pointes
* QTcF \> 450ms despite correction of predisposing factors (i.e electrolytes…)
* Congenital long QTcF
* Unstabilised thyroid disorder
* No health insurance coverage
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
Molecular response (MR) 4.5 at 12 months of nilotinib 300 mg twice a day versus a combination of low-dose Peg-Interferon (Peg-IFN) to nilotinib 300 mg twice a day in newly diagnosed CP-CML Chronic Phase Chronic Myelogenous Leukemia patients.