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Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response

NCT01827930 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-12-31

Study results available
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Summary

The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.

Conditions

  • Leukemia, Myeloid, Chronic-Phase

Interventions

DRUG

Imatinib Mesylate 600 MG Oral Tablet

Imatinib Mesylate for CP CML

DRUG

Imatinib Mesylate 400 MG Oral Tablet

Imatinib Mesylate for CP CML

DRUG

Imatinib Mesylate

Imatinib Mesylate for CP CML

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Institut Bergonié

    lead OTHER

Principal Investigators

  • ETIENNE Gabriel, MD · Institut Bergonié

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2017-01-01
Completion
2017-01-01

Countries

  • France

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 NCT01827930 on ClinicalTrials.gov