MedTrace Logo

Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

NCT01254188 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2016-03-03

Study results available
· View outcomes & findings →

Summary

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Nilotinib

This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.

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
2011-04-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Algeria
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Egypt
  • India
  • Israel
  • Lebanon
  • Malaysia
  • Mexico
  • Oman
  • Russia
  • Saudi Arabia
  • South Africa
  • Taiwan
  • Thailand
  • Tunisia
  • United Arab Emirates

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 NCT01254188 on ClinicalTrials.gov