A Phase II, Single Arm, Multicenter Study of Nilotinib in Combination With Pegylated Interferon-α2b in Patients With Suboptimal Molecular Response or Stable Detectable Molecular Residual Disease After at Least Two Years of Imatinib Treatment (NordDutchCML009)
Study phase: Phase II.
Patient population:
Patients with suboptimal molecular response or stable detectable molecular residual disease
after ≥ 2 years of treatment with imatinib (i.e. BCR ABL level between 0.01% and 1% IS).
Study objective:
To assess the effect of switching CML patients, who have been treated with imatinib ≥ 2
years and who have stable detectable molecular residual disease between 0.01-1.0% (IS), to
the combination of Nilotinib and PegIFN, in terms of the proportion of patients who achieve
confirmed MR4.0.
Study design:
Single arm, open label, multicenter study to assess the efficacy, safety and tolerability of
nilotinib 300 mg BID, alone and in combination with PegIFN 25 - 40 μg/week in patients not
in CMR. Patients will be treated with nilotinib 300 mg BID at the beginning of the study to
establish the tolerability before adding PegIFN. Combination treatment will be continued
until Month 12, which is followed by monotherapy phase of nilotinib 300 mg BID. Overall
study duration for the individual patient is 24 months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the proportion of patients achieving confirmed MR4.0.
An interim efficacy analysis will be prepared after 40 patients have completed 12 months study treatment.If already a sufficient number of patients have achieved the efficacy endpoint i.e. a 25% increase in MR4.0 rate (from 48% in ENEStcmr to 73% in this study). Using Fleming's method, we have indication of superior efficacy of the combination if 29 or more patients achieve MR4.0, and thereafter may stop inclusion in the study.
12 months
No
Jeroen Janssen, MD, PhD
Principal Investigator
VU University Medical Center Amsterdam
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
NordDutchCML009
NCT01866553
April 2013
September 2016
Name | Location |
---|