Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Cumulative rate of significant AE	12 months therapy	The cumulative rate of serious AEs defined by grade 3-4 fluid retention, all grade pleural effusion, haematological grade 3-4 AEs related to dasatinib and/or all AE leading to dasatinib discontinuation within the first year of therapy
Secondary	Rate of treatment interruptions	12 months therapy	To compare the rate of treatment interruptions
Secondary	Cumulative duration of dasatinib interruption	12 months therapy	To compare the cumulative duration of dasatinib interruption C. To compare the median dose of dasatinib administered during the first 12 months
Secondary	Mean dose of dasatinib	12 months therapy	To compare the mean dose of dasatinib administered during the first 12 months
Secondary	Cumulative rate of complete cytogenetic response	12 months therapy	To compare the cumulative rate of complete cytogenetic response (CCR) at 6, 12 and 18 months, and every 12 months thereafter
Secondary	Cumulative rate of major molecular response	12 months therapy	To compare the cumulative rate of major molecular response (MMR) at 3, 6, 12, and 18 months, and every 6 months thereafter
Secondary	Median dose of dasatinib administered	12 months therapy	To compare the median dose of dasatinib administered during the first 12 months
Secondary	Cumulative rate of complete molecular response	12 months therapy	To compare the cumulative rate of complete molecular response at 3, 6, 12 and 18 months, and every 6 months thereafter
Secondary	Time to molecular response	12 months therapy	To compare the time to molecular response (major or complete)
Secondary	Relationship between peak plasmatic level and efficacy	12 months therapy	To analyse the relationship between peak plasmatic level (Cmax) and efficacy in the three arms
Secondary	Relationship between through plasmatic level and efficacy	12 months therapy	To analyse the relationship between through plasmatic level (Cmin) and efficacy in the three arms
Secondary	Progression-free survival at 5 years	12 months therapy	To compare the progression-free survival (PFS) at 5 years in the three arms
Secondary	Overall survival at 5 years	12 months therapy	To compare the overall survival at 5 years in the three arms
Secondary	Lymphocyte populations before and during dasatinib therapy	12 months therapy	To analyse lymphocyte populations before and during dasatinib therapy (for French participating centers - see appendix 14).
Secondary	Rate of sustained major molecular remission after dasatinib discontinuation in patients in complete molecular response	12 months therapy	To evaluate the rate of sustained major molecular remission after dasatinib discontinuation in patients in complete molecular response, CMR (undetectable BCR-ABL transcript, BCR-ABL/ABL IS ratio \< 1x10-5)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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