Tasigna in Glivec-resistant or Intolerant Patients in CML

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Novartis Korea Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Novartis Korea Ltd.
ClinicalTrials.gov Identifier:
NCT01206088
First received: September 20, 2010
Last updated: June 19, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete cytogenetic response rate(CCyR) at 12 months after nilotinib administration.


Condition Intervention Phase
CML
Nilotinib
Imatinib Resistant
Imatinib Intolerant
Drug: nilotinib
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV Study for Nilotinib in Patients With Imatinib-resistant or Intolerant Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase.

Resource links provided by NLM:


Further study details as provided by Novartis Korea Ltd.:

Primary Outcome Measures:
  • Complete cytogenetic response (CCyR) rate [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluation of safety by NCI-CTCAE version 3.0 [ Time Frame: until 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 93
Study Start Date: February 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nilotinib Drug: nilotinib
administration of nilotinib as 2nd line

  Eligibility

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

Inclusion Criteria:

  • Imatinib resistant chronic myelogenous leukemia in chronic phase with cytogenetic confirmation of Philadelphia chromosome.
  • Documented chronic phase CML as defined by:

    • < 15% blasts in peripheral blood and bone marrow
    • < 30% blasts plus promyelocytes in peripheral blood and bone marrow
    • < 20% basophils in the peripheral blood
    • ≥ 100 x 109/L (≥ 100,000 /mm3) platelets
    • No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
    • the patients with no CHR(complete hematologic response) after 3 months treatment, no minical cytogenetic response(Ph+<65%) after 6 months treatment, no major cytogenetic response(Ph+<35%) after 12 months treatment.

Or

  • Imatinib resistant Philadelphia positive CML-AC will be defined as at lease one following and no bast crisis before treatment.

    • <30% and ≥ 15% blasts in peripheral blood and bone marrow
    • ≥ 30% blasts plus promyelocytes in peripheral blood and bone marrow
    • ≥ 20% basophils in the peripheral blood
    • < 100 x 109/L (≥ 100,000 /mm3) platelets without related treatment
    • progression of CML-AP with Imatinib treatment, no hematologic response in bone marrow after at least 4 weeks treatment with imatinib. Progression from AP will be defined by increased numbers more than 50% of peripheral WBCs, blasts, basophils and platelets.
  • definition of Imatinib intolerance in CML-CP and AP

    • the patients who discontined imatinib treatment with any dosage due to Grade 3 or 4 non-hematologic adverse event or Grade 4 hematologic adverse event sustained for more than 7 days even best complementary therapy.
  • WHO performance scale ≤ 2
  • provide signed informed consent form

Exclusion Criteria:

  • Cardiac dysfunction : LVEF <45% by echocardiography, using pacemaker,Congenital long QT syndrome or a known family history of long QT syndrome, History of or presence of clinically significant ventricular or atrial tachyarrhythmias, Clinically significant resting brachycardia (<50 beats per minute),QTc > 450 msec on baseline ECG (using the QTcF formula), Myocardial infarction within 12 months prior to starting study, Other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension).
  • Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
  • Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
  • History of significant congenital or acquired bleeding disorder unrelated to cancer.
  • Treatment with any CSGF within 1 week of Day 1 except Erythropoietin.
  • History of non-compliance to medical regimens or inability to grant consent.
  • Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
  • Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
  • Patients actively receiving therapy with strong CYP3A4 inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil) and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. See link for complete list of these medications: http://medicine.iupui.edu/flockhart/table.htm.. Novartis must be contacted if a patient needs to be started on any of these drugs during study treatment.
  • 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)
  • History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
  • patients who diagnosed HIV infection.
  • patients who has hypersensitivity for nilotinib or its additives
  • Patients who are currently receiving treatment with any 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 (Please see http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm for a comprehensive list of agents that prolong the QT interval)
  • Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial
  • Patients with rare genetic disease such as galactose intolerance, moderate lactase deficiency or glocose-galactose absoption disorder
  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: NCT01206088

Contacts
Contact: Hijung Cho, MD +8227689000 ext 279 hijung.cho@novartis.com
Contact: Juyoung Lee +8227689000 ext 103 juyoung.lee@novartis.com

Locations
Korea, Republic of
St. Mary hospital, Catholic medical center Recruiting
Seoul, Korea, Republic of
Contact: Sahee Park    15881511      
Sponsors and Collaborators
Novartis Korea Ltd.
  More Information

No publications provided

Responsible Party: Hijung Cho, Medical advisor, Oncology, Novartis Korea, Ltd.
ClinicalTrials.gov Identifier: NCT01206088     History of Changes
Other Study ID Numbers: CAMN107AKR02
Study First Received: September 20, 2010
Last Updated: June 19, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Leukemia, Myeloid
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 August 19, 2014