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A Phase II Randomized, Multicenter Study of Treatment-free Remission in Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Patients Who Achieve and Sustain MR4.5 After Switching to Nilotinib


Phase 2
18 Years
N/A
Open (Enrolling)
Both
CML

Thank you

Trial Information

A Phase II Randomized, Multicenter Study of Treatment-free Remission in Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Patients Who Achieve and Sustain MR4.5 After Switching to Nilotinib


Inclusion Criteria:



- Diagnosis of CML

- Treated with at least 1 year of imatinib

- Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by
PCR reported on the International scale. This will be confirmed during screening

- Written informed consent obtained prior to any screening procedures performed

Exclusion Criteria:

- T315I mutation

- Prior imatinib failure or had accelerated phase or blast crisis CML

- Impaired cardiac function (defined futher in the protocol)

- Pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of patients without molecular relapse after stopping nilotinib

Outcome Description:

Proportion of patients without confirmed loss of MR4 within 6 months following nilotinib TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, in the first 6 months after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase.

Outcome Time Frame:

6 months after stopping nilotinib therapy

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107AUS37

NCT ID:

NCT01744665

Start Date:

May 2013

Completion Date:

August 2021

Related Keywords:

  • CML
  • CML, chronic myeloid leukemia, stop, niotinib, discontinue, imatinib, switch, MR4.5, undetectable, bcr-abl
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

University of Rochester Medical CenterRochester, New York  14642
Washington Hospital CenterWashington, District of Columbia  20010
Cancer Center of KansasWichita, Kansas  67214
St. Agnes HospitalBaltimore, Maryland  21229
Northwest Cancer Specialists Vancouver LocationPortland, Oregon  97210
Tennessee Oncology Dept. of Centennial MedicalNashville, Tennessee  37203
CHRISTUS Schumpert Health SystemShreveport, Louisiana  71101
Bay Area Cancer Research Dept.ofBayAreaCancerResearchConcord, California  94520
West Virginia University/ Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506
University of Texas, Houston Medical School UT Physicians OncologyHouston, Texas  77030
Hematology Oncology Associates of Northern New Jersey PA Dept of Hem-Onc of Northern NJMorristown, New Jersey  07962
Florida Cancer Specialists DeptofFloridaCancerSpecialistsFort Myers, Florida  33901
Columbia Basin Hematology SCKennewick, Washington  99336
Compassionate Cancer Care Medical Group CCCMGFountain Valley, California  92708
Weill Cornell Medical College NY Presbyterian HospitalNew York City, New York  10021
Hackensack University Medical Center HUMCHackensack, New Jersey  07601
Stroger Cook County Hospital Division of Hematology & OncChicago, Illinois  60612
Georgia Cancer Specialists Georgia CancerDecatur, Georgia  30033
South Texas Cancer Center- McAllenMcAllen, Texas  78503
Hematology & Oncology Consultants, PC Hematology & OncologyOmaha, Nebraska  68122-1799
Carolina Oncology Specialists, PCHickory, North Carolina  28602
Wake Forest University Baptist Medical Center Hematology and OncologyWinston-Salem, North Carolina  27157
Duke University Medical Center Duke University Med CtrDurham, North Carolina  27710
City of Hope National Medical Center Dept of OncologyDuarte, California  91010-3000
University of Alabama Comprehensive Cancer Center University of Alabama (8)Birmingham, Alabama  35294
Banner MD Anderson Cancer Center Banner MD Anderson (2)Gilbert, Arizona  85234
Scottsdale Healthcare/TGen Clinical Research Service SCScottsdale, Arizona  85258
UC San Diego UC San Diego Cancer CtrLa Jolla, California  92093-0987
MD Anderson Cancer Center - Orlando Cancer CenterOrlando, Florida  32806
H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt Cancer Ctr (67)Tampa, Florida  33612
University of Chicago Medical Center Dept. of Univ. of Chicago HospChicago, Illinois  60637
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Robert H. Lune ComprehensiveChicago, Illinois  60611
Indiana Blood and Marrow Institute St. Francis HealthBeach Grove, Indiana  46107
University of Iowa Hospitals & Clinics Holden Comprehensive Cancer CtIowa City, Iowa  52242
University of Kansas Cancer Center Clinical Research CenterKansas City, Kansas  66160
Hematology Oncology Clinic Hematology Oncology ClinicBaton Rouge, Louisiana  70808
Dana Farber Cancer Institute D F C IBoston, Massachusetts  02115
University of Massachusetts Medical Center UMASS (6)Worcester, Massachusetts  01655
Billings Clinic Billings Clinic (8)Billings, Montana  59107
Montefiore Medical Center Montefiore Medicial CenterBronx, New York  10467
Columbia University Medical Center Herbert Irving PavilionNew York, New York  10032
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (63)New York, New York  10021
SUNY- Stony Brook Medical Oncology Hematology/OncologyStony Brook, New York  11794-8174
Westchester Medical Center NY Medical CollegeValhalla, New York  10595
Ohsu Ohsu (4)Portland, Oregon  97239
University of South Carolina Medical University of SCColumbia, South Carolina  29203
Vanderbilt Univeristy Ingram Cancer Center (10)Nashville, Tennessee  37232
Hendrick Cancer Center Hendricks Cancer CenterAbilene, Texas  79601
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (14)Houston, Texas  77030
Institute of Oncology HematologyLaredo, Texas  78041
University of Utah / Huntsman Cancer Institute Huntsman Cancer CenterSalt Lake City, Utah  84103
University of Virginia Hematology/OncologyCharlottesville, Virginia  22908
Medical College of Wisconsin Med College of WIMilwaukee, Wisconsin  53226