Nilotinib as First-line Treatment of Ph+ CML in Early Chronic Phase (NCT00481052) | Clinical Trial Compass
CompletedPhase 2
Nilotinib as First-line Treatment of Ph+ CML in Early Chronic Phase
Italy74 participantsStarted 2007-06-23
Plain-language summary
Treating Ph pos CML with Imatinib is very effective since the majority of the patients achieve a complete cytogenetic response and a major molecular response and are alive and progression-free after 5 years. However, the great majority of responding patients are not leukemia-free and may be at risk of progression, molecular, cytogenetic and clinical, at any time. In case of disease progression due to Imatinib failure, nilotinib has been found to be very effective, as expected from the preclinical profile of the drug, that is much more potent against BCR-ABL and inhibits nearly all the imatinib-resistant BCR-ABL mutants. For these reasons, nilotinib is going to be registered for the treatment of imatinib-resistant CMl patients. For the same reasons, nilotinib is expected to be more efficient than imatinib also front-line, based on the principle that we should aim at preventing the emergence of resistance better that at treating resistance once it has emerged. This expectation can be tested safely, because the "toxicity profile" of Nilotinib may be even more convenient than that of Imatinib, due to the lower frequency of edema and fluid retention.
Who can participate
Age range18 Years
SexALL
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:
* Patients with a cytologic and cytogenetic confirmed diagnosis of Ph+ CML.
* Age ≥ 18 years old
* Early CP (within 6 months from diagnosis)
* No prior treatment with any antileukemic drugs with the exception of Hydroxyurea (HU) and Anagrelide.
* WHO performance status of ≤ 2
* Normal serum level of potassium, total calcium corrected for serum albumin, magnesium and phosphorus, or correctable with supplements
* ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to leukaemia.
* Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukemia.
* Serum bilirubin ≤ 1.5 x ULN
* Serum creatinine ≤ 1.5 x ULN
* Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN.
* Written informed consent prior to any study procedures being performed.
Exclusion criteria:
* Impaired cardiac function, including LVEF \< 45% as determined by MUGA scan or echocardiogram, uncontrolled congestive heart failure, uncontrolled hypertension
* History of myocardial infarction within three months, or uncontrolled angina pectoris.
* Significant electric heart abnormalities, including history or presence of significant ventricular or atrial tachyarrhythmias, congenital long QT syndrome and/or QTc \> 450 msec on screening ECG (using the QTcF formula).
* Patients with ventricular pacemakers and clinically significant bradycardias.
* Patients with heart blocks.
* History of acute or chronic pancreatitis.
* Impairment of gastrointestinal (GI) function or GI disease that may significan…
What they're measuring
1
Complete cytogenetic response (CCgR ) rate
Timeframe: At 1 year
Trial details
NCT IDNCT00481052
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto