A Phase III Study of Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase CML — DASISION

Myeloid Leukemia, Chronic Clinical Trial

Official title:
An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

Status Completed

Clinical Trial Summary

The purpose of this clinical research study is to compare the rate of confirmed complete cytogenetic response (cCCyR) of dasatinib to imatinib therapy within 12 months after randomization in newly diagnosed chronic phase Philadelphia positive chronic myeloid leukemia (Ph+ CML) patients. The safety of this treatment will also be studied.

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, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Myeloid Leukemia, Chronic
Philadelphia Chromosome

Clinical Trial Details

NCT number	NCT00481247
Study type	Interventional
Source	Bristol-Myers Squibb
Contact
Status	Completed
Phase	Phase 3
Start date	August 2007
Completion date	December 2013

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT00482703` - A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia	Phase 1/Phase 2
Terminated	`NCT02086487` - Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy	Phase 4
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Completed	`NCT00478985` - Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia	N/A
Terminated	`NCT02543749` - DC Vaccination in CML	Phase 1/Phase 2
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Completed	`NCT02890784` - Dasatinib Holiday for Improved Tolerability	Phase 3