for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:



To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5

Official Title

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


CML CML, chronic myeloid leukemia, stop, niotinib, discontinue, imatinib, switch, MR4.5, undetectable, bcr-abl Leukemia, Myelogenous, Chronic, BCR-ABL Positive AMN107 AMN107 2 years of consolidation


You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.


  • UC San Diego UC San Diego Cancer Ctr
    La Jolla California 92093-0987 United States
  • Compassionate Cancer Care Medical Group CCCMG
    Fountain Valley California 92708 United States
  • City of Hope National Medical Center Dept of Oncology
    Duarte California 91010-3000 United States
  • Wilshire Oncology Medical Group Corona Cancer Center
    Multiple Locations California United States


in progress, not accepting new patients
Start Date
Completion Date
Novartis Pharmaceuticals
Phase 2
Study Type
Last Updated
March 1, 2018