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Extension Study to a Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Myelogenous Leukemia, Chronic

Thank you

Trial Information

Extension Study to a Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Inclusion Criteria


Inclusion criteria:

1. Male or female patients ≥ 18 years of age.

2. ECOG 0, 1, or 2.

3. Patients with Ph+ CML who have failed treatment in the core protocol.

4. Diagnosis of chronic myelogenous leukemia with cytogenetic confirmation of
Philadelphia chromosome of (9;22) translocations (presence of BCR-ABL a review of a
minimum 20 metaphases is required).

5. Adequate end organ function as defined by:

- Total bilirubin < 1.5 x ULN,

- SGOT and SGPT < 2.5 x ULN,

- Creatinine < 1.5 x ULN,

- Serum amylase and lipase ≤ 1.5 x ULN,

- Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.

6. Patients must have the following laboratory values (≥ LLN (lower limit of normal) or
corrected to within normal limits with supplements prior to the first dose of study
medication.):

- Potassium ≥ LLN,

- Magnesium ≥ LLN,

- Phosphorus ≥ LLN,

- Total calcium (corrected for serum albumin) ≥ LLN.

Exclusion criteria:

1. Previously documented T315I mutations.

2. Impaired cardiac function including any one of the following:

- LVEF < 45% or below the institutional lower limit of the normal range (whichever
is higher) as determined by locally read echocardiogram.

- Inability to determine the QT interval on ECG.

- Complete left bundle branch block.

- Use of a ventricular-paced 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the efficacy (MMR rate at 12 months) of nilotinib at 400mg/300mg BID with that of Gleevec/Glivec 400 mg QD in newly diagnosed, previously untreated Philadelphia chromosome-positive CML-CP patients.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107A2303E1

NCT ID:

NCT00718263

Start Date:

April 2008

Completion Date:

October 2018

Related Keywords:

  • Myelogenous Leukemia, Chronic
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome
  • Chronic Disease

Name

Location

Tyler Cancer CenterTyler, Texas  75702
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Florida Cancer InstituteNew Port Richey, Florida  34652
Kansas City Cancer Center KCCC Business OfficeOverland Park, Kansas  66210
UCLA/ University of California Los Angeles Dept. of Hematology ClinicLos Angeles, California  90095
Kaiser Permanente - California Southern Dept of Kaiser South 3San Diego, California  
Kaiser Permanente - California Southern Dept of Kaiser South 12San Diego, California  
Kaiser Permanente - California Northern Kaiser MedVallejo, California  
Kaiser Permanente - California Northern Vallejo Med Center/Med OfficesVallejo, California  
Rocky Mountain Cancer Centers RMCC - Colorado SpringsGreenwood Village, Colorado  
Florida Cancer Specialists Dept. FloridaCancerSpecialistsFort Myers, Florida  33901
Advanced Medical Specialties Research Dept.Miami, Florida  33176
Cancer Centers of Florida PA Cancer Centers of FLOcoee, Florida  *see dep*
University of Chicago Medical Center Section of Hematology/OncologyChicago, Illinois  60546
Indiana Blood and Marrow Institute Dept. of Indiana Blood&MarrowBeach Grove, Indiana  46107
University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&ClinicsIowa City, Iowa  52242
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer CenterNew Orleans, Louisiana  70115
Michigan State University / Breslin Cancer Center Breslin Cancer CenterLansing, Michigan  
Missouri Cancer Associates Dept. of Boone Hospital CenterColumbia, Missouri  65201
Hematology Oncology Consultants, Inc. Deptof Hem. Onc.ConsunsultantsSt. Louis, Missouri  63136
Hackensack University Medical Center Department of ResearchHackensack, New Jersey  07601
Memorial Sloan Kettering Cancer Center Clinical Trials OfficeNew York, New York  10021
UNC/Lineberg Comprehensive Cancer Center UNC Lineberger Cancer CenterChapel Hill, North Carolina  27514
Cancer Centers of North Carolina Cancer Centers of NC-RaleighRaleigh, North Carolina  27609
Wake Forest University Baptist Medical Center Dept. of Industry ResearchWinston-Salem, North Carolina  27157
University of Cincinnati / Barrett Cancer Center Dept.of Internal Med.Cincinnati, Ohio  45219
Northwest Cancer Specialists Vancouver LocationPortland, Oregon  97210
Cancer Centers of the Carolinas CC of C -EastsideGreenville, South Carolina  29605
Chattanooga Oncology and Hematology Assoicates, PC Memorial PlazaChattanooga, Tennessee  37404
Tennessee Oncology Dept. of Centennial MedicalNashville, Tennessee  37203
Texas Cancer Center ( Medical City Dallas Hospital)Dallas, Texas  75230
Cancer Care Centers of South Texas / HOAST CCC of So.TX- Medical CenterSan Antonio, Texas  78229
Cleveland Clinic Foundation Dept.ofTaussigCancerCenter(2)Cleveland, Ohio  44195