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
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
To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5
Study protocol included criteria for study termination that was met when > 2 patients lost CCyR during TFR phase (> 1% BCR-ABL); This study was terminated early as > 2 cases of confirmed loss of complete cytogenetic response were reported despite BCR-ABL monitoring during the TFR Phase. All cases achieved MR4.5 after Nilotinib treatment re-initiation and maintained until end of study; trial did not mandate re-initiation within 4 weeks after loss of MMR_ that was a requirement in other Nilotinib TFR trials Initial sample size was 300 patients with CML-CP; Amendment #2 in June 2015 reduced sample size to 59 due to recruitment challenges; Study endpoint analysis and interpretations of data were challenging due to small sample size for early study closure..
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35294, United States
Multiple Locations, California, United States
Sacramento, California 95816-5199, United States
Tampa, Florida 33612, United States
Iowa City, Iowa 52242, United States
Kansas City, Kansas 66160, United States
Lansing, Michigan, United States
Billings Montana, Montana 59101, United States
Hackensack, New Jersey 07601, United States
Morristown, New Jersey 07962, United States
Winston-Salem, North Carolina 27157, United States
Columbus, Ohio 43210, United States
Columbia, South Carolina 29203, United States
Salt Lake City, Utah 84103, United States
Morgantown, West Virginia 26506, United States