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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01274351
First received: January 4, 2011
Last updated: July 6, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Chronic Myelogenous Leukemia
Drug: Tasigna
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of complete cytogenetic response (CCyR) by 6 and 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Rate of molecular response at 3 monthly basis [ Time Frame: 3 monthly intervals ] [ Designated as safety issue: No ]
  • Rate of hematologic response [ Time Frame: 3 monthly intervals ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]
  • Time and duration of major molecular response (MMR) [ Time Frame: 3 monthly intervals ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: January 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Tasigna

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274351

Locations
Turkey
Novartis Investigative Site
Adana, Turkey, 01330
Novartis Investigative Site
Adana, Turkey
Novarts Investigative Site
Ankara, Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Ankara, Turkey
Novarts Investigative Site
Antalya, Turkey
Novartis Investigative Site
Bursa, Turkey
Novartis Investigative Site
Bursa, Turkey, 16059
Novartis Investigative Site
Diyarbakir, Turkey, 21000
Novartis Investigative Site
Diyarbakir, Turkey
Novartis Investigative Site
Eskişehir, Turkey
Novartis Investigative Site
Gaziantep, Turkey, 27070
Novartis Investigative Site
Istanbul, Turkey
Novartis Investigative Site
Istanbul, Turkey, 34303
Novartis Investigative Site
Istanbul, Turkey, 34093
Novartis Investigative Site
Izmir, Turkey
Novartis Investigative Site
Izmir, Turkey, 35040
Novarts Investigative Site
Izmir, Turkey
Novartis Investigative Site
Izmir, Turkey, 35340
Novartis Investigative Site
Kayseri, Turkey
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
Novartis Investigative Site
Trabzon, Turkey, 61080
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01274351     History of Changes
Other Study ID Numbers: CAMN107ETR02
Study First Received: January 4, 2011
Last Updated: July 6, 2014
Health Authority: United States: Food and Drug Administration
Turkey: Ministry of Health

Keywords provided by Novartis:
First line treatment
newly diagnosed
Philadelphia chromosome positive
Chronic Myelogenous Leukemia
Ph+
CML-CP
major molecular response
Social risk

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

ClinicalTrials.gov processed this record on October 19, 2014