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Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations

NCT01131325 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-05-20

Study results available
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Summary

This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.

Conditions

  • CML
  • Philadelphia Chromosome Positive (Ph+)
  • Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels

Interventions

DRUG

nilotinib

All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-21
Primary Completion
2011-05-12
Completion
2011-05-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01131325 on ClinicalTrials.gov