Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01274351
Recruitment Status : Active, not recruiting
First Posted : January 11, 2011
Last Update Posted : December 5, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Myelogenous Leukemia Drug: Tasigna Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 25, 2011
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: Nilotinib Drug: Tasigna

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Rate of complete cytogenetic response (CCyR) by 6 and 12 months [ Time Frame: 6 and 12 months ]
  2. Rate of molecular response at 3 monthly basis [ Time Frame: 3 monthly intervals ]
  3. Rate of hematologic response [ Time Frame: 3 monthly intervals ]
  4. Number of patients with adverse events [ Time Frame: Every visit ]
  5. Time and duration of major molecular response (MMR) [ Time Frame: 3 monthly intervals ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01274351

Novartis Investigative Site
Istanbul, TUR, Turkey, 34098
Novartis Investigative Site
Adana, Turkey, 01330
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Bursa, Turkey, 16059
Novartis Investigative Site
Diyarbakir, Turkey, 21000
Novartis Investigative Site
Gaziantep, Turkey, 27310
Novartis Investigative Site
Istanbul, Turkey, 34093
Novartis Investigative Site
Izmir, Turkey, 35040
Novartis Investigative Site
Izmir, Turkey, 35340
Novartis Investigative Site
Meselik / Eskisehir, Turkey, 26480
Novartis Investigative Site
Okmeydani / Istanbul, Turkey, 34370
Novartis Investigative Site
Talas / Kayseri, Turkey, 38039
Novartis Investigative Site
Trabzon, Turkey, 61080
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01274351     History of Changes
Other Study ID Numbers: CAMN107ETR02
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
First line treatment
newly diagnosed
Philadelphia chromosome positive
Chronic Myelogenous Leukemia
major molecular response
Social risk

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes