Gleevec as Maintenance Therapy After Cytogenetic Response With Nilotinib in Newly Diagnosed Chron… (NCT01316250) | Clinical Trial Compass
CompletedNot Applicable
Gleevec as Maintenance Therapy After Cytogenetic Response With Nilotinib in Newly Diagnosed Chronic Myelogenous Leukemia
Lebanon13 participantsStarted 2010-08
Plain-language summary
The results of the International Randomized Study of Interferon and STI571 (IRIS) trial indicate that in patients with chronic phase CML treated with first line imatinib, achievement of a complete or partial cytogenetic response (CCyR or PCyR) at 12 months is associated with a significantly better progression-free survival (PFS).
Second generation tyrosine kinase inhibitors such as nilotinib can overcome imatinib resistance because of greater potency to bind to BCR-ABL. Recent results indicate that, in patients with previously untreated chronic phase CML, nilotinib results in a faster and higher rate of CCyR or PCyR than imatinib. However, nilotinib use is associated with diet restriction and much higher financial cost.
The primary objective of this study is to evaluate the ability of imatinib to maintain a complete cytogenetic response (CcyR) in patients who achieved a CCyR after 12 months of first-line treatment with nilotinib.
Who can participate
Age range
18 Years – 75 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
. Newly diagnosed untreated Philadelphia chromosome-positive CML (use of hydroxyurea for \<3 months is allowed) in chronic phase defined with the following criteria:
. Patients (pts) ≥18 yrs of age
. WHO Performance Status of ≤2
. Pts must have the following laboratory values:
. Written signed informed consent prior to any study procedures
Exclusion criteria
. Cytopathologically confirmed central nervous system (CNS) infiltration
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
To test the ability of imatinib to maintain the cytogenetic response in patients who achieved complete cytogenetic response (CCyR) at 12 months with first line nilotinib.
Timeframe: January 2010-January 2015
Trial details
NCT IDNCT01316250
SponsorAmerican University of Beirut Medical Center
. Impaired cardiac function, including any one of the following:
. Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol) up to day before study drug administration
. Acute or chronic liver or renal disease considered unrelated to tumor such as active Hepatitis A, B, or C
. Other concurrent severe and/or uncontrolled medical conditions
. Pts who are currently receiving treatment with any of the medications that have the potential to prolong QT interval
. Pts who have received any investigational drug ≤4 weeks or investigational cytotoxic agent within 1 week (or who are within 5 half-lives of a previous investigational cytotoxic agent) prior to starting study drug or who have not recovered from side effects of such therapy
. Pts who have received wide field radiotherapy ≤4 weeks or limited field radiation for palliation \<2 weeks prior to starting study drug or who have not recovered from side effects of such therapy