CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 262 enrolled
Drug / intervention
Imatinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01593254
NCT01593254Phase 2Completed
CompareCT.gov

An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib

Bristol-Myers Squibb·interventional·Posted May 8, 2012·Updated Jun 22, 2023

In Brief

A Phase 2 clinical trial evaluating Imatinib and Dasatinib for Chronic Phase Chronic Myeloid Leukemia. Completed, enrolled 262 participants across 101 sites in 15 countries.

Detailed Summary

The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Phase Chronic Myeloid Leukemia
CountriesArgentina, Austria, Belgium, Brazil, Canada, China, Czechia, France, Hungary, Italy, Poland, South Korea, Spain, Thailand, United States
CollaboratorsICON Clinical Research, PPD Development, LP, Molecular MD, MultiPharma, Q2 Solutions, Donald E. Morisky, MD Anderson Symptom Inventory (MDASI-CML), OBiS, Inc, Steering Committee

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 8, 2012
Enrollment StartSep 12, 2012
Primary CompletionNov 8, 2017
Study CompletionApr 12, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 14.2 years ago

Interventions

Imatinibdrug

Dasatinibdrug