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Efficacy and Safety of Nilotinib in CML-CP

NCT03332511 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2017-11-06

No results posted yet for this study

Summary

ENESTKorea is a phase 4, multi-institutional, single-arm, open-label study investigating the efficacy and safety of nilotinib at the currently approved dose (300 mg twice daily) and its exposure-outcome relationship, in adult patients diagnosed as Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Conditions

  • Chronic Myeloid Leukemia, Chronic Phase

Interventions

DRUG

Nilotinib

Nilotinib 300mg twice-daily

Sponsors & Collaborators

Principal Investigators

  • Inho Kim, MD · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-06
Primary Completion
2016-10-24
Completion
2016-10-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03332511 on ClinicalTrials.gov