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A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase

NCT02272777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2019-08-19

Study results available
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Summary

The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in this extension study patient continued treatment of the drug (imatinib or nilotinib) which they were taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 were retained. As long as EC approval and agreement from investigators were obtained, the selected sites for CAMN107ECN02 were applied in this extension study.

Conditions

Interventions

DRUG

Imatinib

Imatinib 400mg QD，300mg QD or 600mg QD

DRUG

Nilotinib

Nilotinib 300mg BID or 400mg QD

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-17
Primary Completion
2017-01-30
Completion
2017-01-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases
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 NCT02272777 on ClinicalTrials.gov