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
18 Years
N/A
Open (Enrolling)
Both
CML
Both
CML
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 Center | Rochester, New York 14642 |
| Washington Hospital Center | Washington, District of Columbia 20010 |
| Cancer Center of Kansas | Wichita, Kansas 67214 |
| St. Agnes Hospital | Baltimore, Maryland 21229 |
| Northwest Cancer Specialists Vancouver Location | Portland, Oregon 97210 |
| Tennessee Oncology Dept. of Centennial Medical | Nashville, Tennessee 37203 |
| CHRISTUS Schumpert Health System | Shreveport, Louisiana 71101 |
| Bay Area Cancer Research Dept.ofBayAreaCancerResearch | Concord, California 94520 |
| 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 |
| University of Chicago Medical Center Dept. of Univ. of Chicago Hosp | Chicago, Illinois 60637 |
| NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Robert H. Lune Comprehensive | Chicago, Illinois 60611 |
| 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 |
