Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML

Myeloid Leukemia, Chronic, Chronic-Phase Clinical Trial

Official title:
A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

Status Completed

Clinical Trial Summary

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Myeloid Leukemia, Chronic, Chronic-Phase

Clinical Trial Details

NCT number	NCT00123474
Study type	Interventional
Source	Bristol-Myers Squibb
Contact
Status	Completed
Phase	Phase 3
Start date	July 2005
Completion date	July 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02348957` - Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib
Terminated	`NCT00114959` - Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)	Phase 2
Completed	`NCT00510926` - Exploratory Study of IMATINIB High Dose in Intermediate Risk Chronic Myeloid Leukemia in Chronic Phase	Phase 2
Withdrawn	`NCT00324077` - Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase	Phase 1