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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



University of Rochester Medical CenterRochester, New York  14642
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St. Agnes HospitalBaltimore, Maryland  21229
Northwest Cancer Specialists Vancouver LocationPortland, Oregon  97210
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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
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Hackensack University Medical Center HUMCHackensack, New Jersey  07601
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Scottsdale Healthcare/TGen Clinical Research Service SCScottsdale, Arizona  85258
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MD Anderson Cancer Center - Orlando Cancer CenterOrlando, Florida  32806
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University of Chicago Medical Center Dept. of Univ. of Chicago HospChicago, Illinois  60637
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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
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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
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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
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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