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Efficacy of Nilotinib Versus Imatinib in Ph+ CML in Early CP Who Have a Suboptimal Molecular Response to Imatinib

NCT01400074 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-01-13

No results posted yet for this study

Summary

In this study, the efficacy of nilotinib at 400 mg BID will be compared with imatinib at 400 mg BID in suboptimal molecular response patients. To determine study eligibility, suboptimal molecular response will be defined as patients who have achieved a complete cytogenetic response (CCyR) but have not achieved a MMR, after at least 18 months of treatment on first line imatinib therapy at a minimum dose of 400mg daily (Baccarani 2006).

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Nilotinib, Imatinib

Nilotinib: 400 mg twice daily Imatinib: 400 mg twice daily

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Seoul St. Mary's Hospital

    lead OTHER

Principal Investigators

  • Dong-Wook Kim, MD, PhD · Seoul St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • South Korea

Study Locations

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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 NCT01400074 on ClinicalTrials.gov