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.

Novartis Pharmaceuticals1 site in 1 country93 target enrollmentFebruary 2009

ConditionsCML Nilotinib Imatinib Resistant Imatinib Intolerant

Interventionsnilotinib

Drugsnilotinib

Overview

Phase: Phase 4
Intervention: nilotinib
Conditions: CML
Sponsor: Novartis Pharmaceuticals
Enrollment: 93
Locations: 1
Primary Endpoint: Complete cytogenetic response (CCyR) rate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

September 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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 mimical cytogenetic response(Ph+\<65%) after 6 months treatment, no major cytogenetic response(Ph+\<35%) after 12 months treatment.
•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

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)