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Novartis marks World CML Day with update on global research program to evaluate whether Ph+ CML patients can live treatment-free
Date:9/19/2013

clinical trial program, molecular response (reduction of BCR-ABL transcripts in the blood of patients) is measured at four levels, based on an international standard:

  • MMR (<= 0.1% BCR-ABL)
  • MR4 (<= 0.01% BCR-ABL)
  • MR4.5 (<= 0.0032% BCR-ABL)
  • Undetectable BCR-ABL (no detectable BCR-ABL transcript level with sample sensitivity of at least 4.5 log)

Globally, Novartis is sponsoring four treatment-free remission studies and providing support for four investigator-initiated studies. More information on the Novartis-sponsored trials, including addresses and contact information for each study site, can be found at:

Stopping treatment is not a clinical recommendation and should only be attempted in the context of a well conducted clinical study. A very important part of these treatment-free remission studies is the inclusion of regular molecular monitoring with International Scale Real-Time Quantitative Polymerase Chain Reaction (IS RT-Q-PCR) testing. Once treatment is stopped molecular monitoring is used to identify if a patient's level of disease remains in deep molecular response or if the reintroduction of treatment is needed.

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