Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)

Official Title

A Phase II, Single Arm, Open Label Study of Treatment-free Remission in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) Patients After Achieving Sustained MR4.5 on Nilotinib

Summary:

A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.

Trial Description

Primary Outcome:

  • No documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy
Secondary Outcome:
  • No documented confirmed loss of MR4, no documented loss of MMR and no re-starting of nilotinib therapy in the first 24, 36, and 48 months following nilotinib cessation.
  • Progression to AP/BC or death where the "failure" event is the earliest occurrence of the following event: progression to AP/BC or death from any cause.
  • Treatment free survival (TFS) defined as lack any of the following events: loss of MMR, confirmed loss of MR4, re-start of Nilotinib treatment, progression to AP/BC or death from any cause.
  • Overall survival (OS) defined as the time from the date of cessation of nilotinib therapy to the date of death from any cause.
  • BCR-ABL transcript changes within 12 months after re-start of nilotinib therapy

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society