Trial intelligence / Profile preview

Nilotinib in newly diagnosed CML-CP (ENESTxtnd)

NCT01254188Phase 3

Key facts

Status: Completed
Start: Apr 2011
Primary completion: Nov 2014
Countries: 19
Sponsor: Novartis
Modality: Small Molecules

Drugs: nilotinib
Conditions: chronic myeloid leukemia (CML)

Overview

Phase 3, open-label, single-arm trial of nilotinib in chronic myeloid leukemia (CML), sponsored by Novartis. Primary endpoint: Percentage of Patients Achieving Major Molecular Response (MMR) at 12 months. Started Apr 2011; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Nilotinib
Nilotinib 300 mg BID

Who it enrols

Newly diagnosed CML-CP patients within 6 months of diagnosis, no prior TKI therapy > 2 weeks.

Endpoints

Primary

Percentage of Patients Achieving Major Molecular Response (MMR)12 months

Secondary

Time to Molecular Response24 months
Duration of Major Molecular Response24 months
Complete Cytogenetic Response6 months
Percentage of Participants Estimated to Maintain Their First CCyR24 months
Overall Survival24 months
Progression-free Survival24 months
Failure-free Survival24 months

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