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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
Open (Enrolling)

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:


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:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




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



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Cancer Center of Kansas Wichita, Kansas  67214
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West Virginia University/ Mary Babb Randolph Cancer Center Morgantown, West Virginia  26506
University of Texas, Houston Medical School UT Physicians Oncology Houston, Texas  77030
Hematology Oncology Associates of Northern New Jersey PA Dept of Hem-Onc of Northern NJ Morristown, New Jersey  07962
Florida Cancer Specialists DeptofFloridaCancerSpecialists Fort Myers, Florida  33901
Columbia Basin Hematology SC Kennewick, Washington  99336
Compassionate Cancer Care Medical Group CCCMG Fountain Valley, California  92708
Weill Cornell Medical College NY Presbyterian Hospital New York City, New York  10021
Hackensack University Medical Center HUMC Hackensack, New Jersey  07601
Stroger Cook County Hospital Division of Hematology & Onc Chicago, Illinois  60612
Georgia Cancer Specialists Georgia Cancer Decatur, Georgia  30033
South Texas Cancer Center- McAllen McAllen, Texas  78503
Hematology & Oncology Consultants, PC Hematology & Oncology Omaha, Nebraska  68122-1799
Carolina Oncology Specialists, PC Hickory, North Carolina  28602
Wake Forest University Baptist Medical Center Hematology and Oncology Winston-Salem, North Carolina  27157
Duke University Medical Center Duke University Med Ctr Durham, North Carolina  27710
City of Hope National Medical Center Dept of Oncology Duarte, 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 SC Scottsdale, Arizona  85258
UC San Diego UC San Diego Cancer Ctr La Jolla, California  92093-0987
MD Anderson Cancer Center - Orlando Cancer Center Orlando, Florida  32806
H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt Cancer Ctr (67) Tampa, Florida  33612
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Indiana Blood and Marrow Institute St. Francis Health Beach Grove, Indiana  46107
University of Iowa Hospitals & Clinics Holden Comprehensive Cancer Ct Iowa City, Iowa  52242
University of Kansas Cancer Center Clinical Research Center Kansas City, Kansas  66160
Hematology Oncology Clinic Hematology Oncology Clinic Baton Rouge, Louisiana  70808
Dana Farber Cancer Institute D F C I Boston, 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 Center Bronx, New York  10467
Columbia University Medical Center Herbert Irving Pavilion New York, New York  10032
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (63) New York, New York  10021
SUNY- Stony Brook Medical Oncology Hematology/Oncology Stony Brook, New York  11794-8174
Westchester Medical Center NY Medical College Valhalla, New York  10595
Ohsu Ohsu (4) Portland, Oregon  97239
University of South Carolina Medical University of SC Columbia, South Carolina  29203
Vanderbilt Univeristy Ingram Cancer Center (10) Nashville, Tennessee  37232
Hendrick Cancer Center Hendricks Cancer Center Abilene, Texas  79601
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (14) Houston, Texas  77030
Institute of Oncology Hematology Laredo, Texas  78041
University of Utah / Huntsman Cancer Institute Huntsman Cancer Center Salt Lake City, Utah  84103
University of Virginia Hematology/Oncology Charlottesville, Virginia  22908
Medical College of Wisconsin Med College of WI Milwaukee, Wisconsin  53226