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A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Chronic Myelogenous Leukemia in Chronic Phase

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Trial Information

A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)


Inclusion Criteria:



Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years
of age. Patients must have adequate end organ function.

Exclusion Criteria:

Previously documented T315I mutation. Other CML treatment is an exclusion criteria with
the following exception: While awaiting study start, patients may be treated with
anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit),
and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for
frontline treatment. Patients taking a TKI prior to study entry must have at least a one
day washout from their last dose of medication and have recovered from any side effects of
such therapy.

Impaired cardiac function as defined by the protocol. Patients with contraindications to
receiving nilotinib, including concomitant medications.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of confirmed Complete Molecular Response (CMR)

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107AUS28

NCT ID:

NCT01227577

Start Date:

November 2010

Completion Date:

December 2017

Related Keywords:

  • Chronic Myelogenous Leukemia in Chronic Phase
  • CML
  • Chronic Myelogenous Leukemia
  • Leukemia
  • CML-CP
  • Nilotinib
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

Name

Location

Henry Ford HospitalDetroit, Michigan  48202
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
St. Mary's Medical CenterHuntington, West Virginia  25701
Montefiore Medical CenterBronx, New York  10467-2490
University of VirginiaCharlottesville, Virginia  22908
Oregon Health & Science UniversityPortland, Oregon  97201
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Cabrini Center for Cancer CareAlexandria, Louisiana  71301
The Jones ClinicGermantown, Tennessee  38138
Pasco Hernando OncologyNew Port Richey, Florida  34652
Cancer Center of KansasWichita, Kansas  67214
Northwest Cancer CenterHouston, Texas  77042
Advanced Medical SpecialtiesMiami, Florida  33176
Pacific Cancer Medical Center, Inc.Anaheim, California  92801
Denver Health Medical Center CACZ885M2301Denver, Colorado  80204-4507
Providence Regional Cancer PartnershipEverett, Washington  98201
St. Louis University Cancer CenterSt. Louis, Missouri  63110
Chattanooga Oncology and Hematology Assoicates, PC Memorial PlazaChattanooga, Tennessee  37404
Tennessee Oncology Dept. of Centennial MedicalNashville, Tennessee  37203
Rush-Presbyterian St. Luke's Medical CenterChicago, Illinois  60612
Bay Area Cancer Research Dept.ofBayAreaCancerResearchConcord, California  94520
St. Agnes Hospital Dept.ofSt.AgnesHospitalBaltimore, Maryland  21229
St. Jude Heritage Medical Group Virginia Crosson Cancer CenterFullerton, California  92835
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3)New Orleans, Louisiana  70115
Hackensack University Medical Center Dept.of HackensackUniv.MedCtr.Hackensack, New Jersey  07601
Hematology Oncology Services of Arkansas Dept. of HOSALittle Rock, Arkansas  72205
Compassionate Cancer Care Medical Group CCCMGFountain Valley, California  92708
The Oncology Institute of Hope and InnovationWhittier, California  90606
Providence St. Joseph Medical Center Roy&Patricia Disney Fam CancerBurbank, California  91505-6866
Compassionate Cancer Care Medical Group Dept.ofCCCMG-RiversideFountain Valley, California  92708
Redwood Regional Medical Group - Santa RosaSanta Rosa, California  94503
University of Colorado Colorado UnivAurora, Colorado  80045
Cancer Care of North Florida, P.A. Cancer Care - Lake City, FL (2Lake City, Florida  32024
Georgia Health Sciences University MedCollege of GA Cancer Ctr 2Augusta, Georgia  30912
Stroger Cook County Hospital Division of Hematology & OncChicago, Illinois  60612
Northwest Oncology & Hematology Cancer InstituteElk Grove Village, Illinois  60007
Indiana Blood and Marrow InstituteBeach Grove, Indiana  46107
U of MarylandBaltimore, Maryland  21201
University of Nebraska Medical Center University of Nebraska Med CtrOmaha, Nebraska  68198
St. Joseph's Regional Medical Center St. Joseph's Regional MC (3)Paterson, New Jersey  07503
U of Rochester Medical Ct James P Wilmot Cancer CtrRochester, New York  14642
SUNY at Stony Brook SUNY at Stony Brook 2Stony Brook, New York  11794-8161
Oncology Consultants Oncology Consultants, P.A.Houston, Texas  77024
Duke University Medical Center Duke University Med CtrDurham, North Carolina  27710
University Hospital University Hospital (2)Cincinnati, Ohio  45219-2316
Penn State University / Milton S. Hershey Medical Center Penn Milton Hershey Ctr (2)Hershey, Pennsylvania  17033-085
Cancer Centers of the Carolinas Cancer CenterGreenville, South Carolina  29605
Baylor Research Institute Baylor Research Institute (17)Dallas, Texas  75204