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

CMLCML, chronic myeloid leukemia, stop, niotinib, discontinue, imatinib, switch, MR4.5, undetectable, bcr-ablLeukemia, Myelogenous, Chronic, BCR-ABL PositiveAMN107AMN107 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 JollaCalifornia92093-0987United States
  • Compassionate Cancer Care Medical Group CCCMG
    Fountain ValleyCalifornia92708United 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