CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
Dasatinibdrug
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/NCT01850004
NCT01850004Phase 2Completed
CompareCT.gov

Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE

Bristol-Myers Squibb·interventional·Posted May 9, 2013·Updated Nov 3, 2022

In Brief

A Phase 2 clinical trial evaluating Dasatinib for Chronic Phase Chronic Myeloid Leukemia. Completed, enrolled 84 participants across 28 sites in 6 countries.

Detailed Summary

The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL residual disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Phase Chronic Myeloid Leukemia
CountriesCanada, France, Germany, Italy, Spain, United States
CollaboratorsICON plc, PPD Development, LP, Molecular MD, European Organisation for Research and Treatment of Cancer - EORTC, MultiPharma, Steering Committee

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2013
Enrollment StartJan 22, 2014
Primary CompletionSep 20, 2017
Study CompletionOct 8, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.1 years ago

Interventions

Dasatinibdrug