A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia Treated With Nilotinib

Summary

Participation Requirements

Description

The purpose of the present study is to evaluate the rate of full treatment-free molecular remission in a selected population of CML-CP patients treated with nilotinib at half the standard dose during a consolidation period of 12 months, followed by complete therapy cessation. The study is made up of...

The purpose of the present study is to evaluate the rate of full treatment-free molecular remission in a selected population of CML-CP patients treated with nilotinib at half the standard dose during a consolidation period of 12 months, followed by complete therapy cessation. The study is made up of 4 phases: Screening (week -4 - week 0) Nilotinib consolidation (week 0 - week 48) Nilotinib treatment-free remission (TFR) phase (week 48 - week 144) Follow up phase Patients fulfilling this protocol-specific definition of sustained deep molecular response (DMR) and all other inclusion/exclusion criteria will start the consolidation phase of the study. During Nilotinib consolidation (week 0 - week 48) period, patients will be treated with nilotinib 300 mg QD. At the end or during the consolidation period, patients will proceed as follows: Patients with sustained DMR at the end of the consolidation phase will enter the tretament-free remission (TFR) phase and nilotinib will be discontinued. Patients with loss of major molecular response (MMR) at any time during the consolidation phase will enter the follow-up phase and will return to the standard nilotinib administration regimen (nilotinib 300 mg BID) until the end of the trial (week 144). Loss of MMR is defined as breakpoint cluster region--c-abl oncogene 1 (BCR-ABL) >0.1% international scale assessed in a single blood sample and will mandate reinitiation of nilotinib treatment at 300 mg BID within 5 weeks after the collection of the blood sample demonstrating loss of MMR. Patients with more than MMR, but without meeting the definition of sustained DMR, will remain in the consolidation phase and will be treated with nilotinib 300 mg QD until the end of the trial (week 144). During the TFR phase, BCR-ABL levels will be monitored every month for the first year at weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 and then every three months until the end of the study at weeks 108, 120, 132 and 144 (end of study) or whenever clinically indicated at the discretion of the investigator. The primary objective will be evaluated at week 96. During the TFR phase, loss of MMR will cause reinitiation of nilotinib treatment at 300 mg BID. Follow up phase for patients who were discontinued from the trial, starting from the date of trial discontinuation up to the end of the trial (144 week), and for patients with loss of MMR at any time during the study. Patients discontinued from the treatment for any reason will be followed for survival information every 3 months until week 144. All patients still on study treatment at the end of the study will be transitioned to prescription nilotinib.

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