Summary

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

Description

Summary

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

Keywords

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

Eligibility

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.

Locations

  • 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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT01744665
Phase
Phase 2
Study Type
Interventional
Last Updated