This trial is active, not recruiting.

Condition chronic myelogenous leukemia
Treatment tasigna
Phase phase 2
Sponsor Novartis Pharmaceuticals
Start date January 2011
End date January 2017
Trial size 112 participants
Trial identifier NCT01274351, CAMN107ETR02


This study is designed to investigate the molecular and cytogenetic effects and safety profile of nilotinib in the treatment of early chronic phase of Ph+ CML among different risk groups of patients and to compare patients with high Socal risk score with patients having intermediate and low Socal risk score.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Rate of major molecular response (MMR) by 12 months and comparison of major molecular response (MMR) rates by 12 months between high sokal risk patients and low&intermediate sokal risk patients
time frame: 3 monthly intervals until 12 month

Secondary Outcomes

Rate of complete cytogenetic response (CCyR) by 6 and 12 months
time frame: 6 and 12 months
Rate of molecular response at 3 monthly basis
time frame: 3 monthly intervals
Rate of hematologic response
time frame: 3 monthly intervals
Number of patients with adverse events
time frame: Every visit
Time and duration of major molecular response (MMR)
time frame: 3 monthly intervals

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 - First cytogenetic diagnosis of CML-CP with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations within 6 months. Standard conventional cytogenetic analysis must be performed. - Previously untreated for CML, except for hydroxyurea and/or anagrelide (except imatinib treatment for max. 31 days long) - Adequate end organ function with following laboratory criteria: total bilirubin < 1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN); creatinine < 1.5 x upper limit of normal (ULN); serum amylase and lipase ≤ 1.5 x upper limit of normal (ULN); alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN) unless considered tumor related - Serum potassium, magnesium, and phosphorus levels are equal or above the lower limit of normal prior to the first dose of study medication Exclusion Criteria: - Treatment with tyrosine kinase inhibitor(s) prior to study (in emergent cases where the patient requires disease management while awaiting study start, commercial supplies of imatinib at any dose may be prescribed to the patient but for no longer than 31 days in duration) - Known cytopathologically confirmed Central Nervous System CNS infiltration - Impaired cardiac function - Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection) - Acute or chronic liver, pancreatic or severe renal disease considered unrelated to disease - Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention - History of significant congenital or acquired bleeding disorder unrelated to cancer - Previous radiotherapy to ≥25% of the bone marrow - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery) - Use of therapeutic coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon) - Patients actively receiving therapy with strong Cytochrome P450 3A4 isoenzyme (CYP3A4) inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil) - Patients actively receiving therapy with medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title A Phase II Multi-center, Open-label, Non-randomized Study of Nilotinib as First Line Treatment in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novartis.