chronic myeloid leukemia
Conditions
Interventions
- a Nilotinb treatment phase for 24 months
- Treatment -Free Remission (TFR) phase, if patient has re-achieved a MR4 for
at least 1 year and MR4.5 for at least 0.5 year.
Sponsors
Universiteit van Heidelberg
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: · Age >= 18 years · Patients with Ph -chromosome and/or the BCR-ABL fusion gene (either b3a2 and/or b2a2) positive CML · CML in CP having failed prior attempt(s) to stop imatinib or other TKIs therapy either within EURO-SKI or not · Pretreatment at least one year with any TKI after 1st or 2nd stop · Written informed consent
Exclusion criteria
Exclusion criteria: · Previous hematological relapse after first or second stop of TKI. · Failure to any TKI at any time during CML treatment TKI according to actual ELN criteria · Previous planned or performed allo SCT · Previous AP/BC at any time in the history of the disease · High cardiac risk according to ESC Score · Contraindication against nilotinib (see following) · Impaired cardiac function including any of the following: o Use of a ventricular paced pacemaker; congenital long QT syndrome or family history of; history or presence of significant ventricular or atrial tachyarrhythmias; clinically significant resting bradycardia (450 msec at baseline, myocardial infarction before baseline; other clinically significant heart disease (e.g., unstable angina, congestive heart failure, or uncontrolled hypertension). · Treatment with inhibitors of CYP3A4 or medications that have been well documented to prolong the QT interval is contraindicated. · History of acute pancreatitis within one year of study entry or medical history of chronic pancreatitis. · Positive hepatitis B virus serology test or HBV infection. · Any other malignancy except if neither clinically significant nor requires active intervention. · Severe or uncontrolled medical conditions (i.e., uncontrolled diabetes, acute or chronic liver disease, pancreatic, or severe renal disease unrelated to tumor, active or uncontrolled infection). · Women who are pregnant, breast feeding, or of childbearing potential without a negative serum pregnancy test at baseline. Male or female patients of childbearing potential unwilling to use an effective barrier contraceptive method.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is molecular relapse-free survival, measured at 12 months and 36 months after 2nd stop or 3rd stop. | — |
Secondary
| Measure | Time frame |
|---|---|
| - number of patients who re-achieved stable MR4.5, and were proposed a 2nd stop or 3rd stop - number of patients who accepted/refused 2nd stop or 3rd stop 2 and 3 years after study entry; whereas stable MR4.5 is defined as two PCRs during 6 months before stopping demonstrating MR4.5 - safety profile, tolerability and AEs under nilotinib treatment - QoL profiles under nilotinib treatment and comparison with previous TKI therapy before switch and after stopping - overall and progression-free survival, and probabilities of a restart of TKI treatment without prior molecular relapse - Time to re-achievement of MR4.5 after restart of therapy - incidence of any AEs (e.g. from musculoskeletal system) that arise after stopping TKI treatment a second time | — |
Countries
Netherlands
Outcome results
None listed