Registered outcomes13

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

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Rate of GI-Toxicity (i.e. incidence and severity of grade 2 to 4 toxicities)	within the first 6 months of treatment	calculation of the incidence rate of grade 2 to 4 GI toxicity with and without regard to causality
Secondary	overall Tolerability (i.e. all grade, grade 2 to 4 and grade 3 and 4 toxicities)	at month 6, 12 and 24	Apart from grade 2 to 4 GI toxicity, the occurrence of toxicity will be analyzed in general. This regards all grade toxicity, 2 to 4 grade and 3 to 4 grade toxicity (NCI CTCAE v4.0).
Secondary	Molecular response mesured by efficacy parametern	at month 3, 6, 12, 18 and 24	Rating of CCyR, MMR, MR4 and MR4.5 after bone marrow aspiration and biopsy
Secondary	Patient-reported outcome measures (QoL)	at month 3 and 6	The EORTC QLQ-CML30 will be scored according to the respective user's guides.
Secondary	Progression-free survival (PFS)	at month 3, 6, 9, 12, 15, 18, 21 and 24	Progression will be assessed according to the visit schedule at any visit.
Secondary	Overall Survival (OS)	at month 3, 6, 9, 12, 15, 18, 21 and 24	Survival will be assessed according to the visit schedule at any visit.
Secondary	The rate of emerging mutations during Bosutinib treatment	at month 3, 6, 9, 12, 15, 18, 21 and 24	The rate and type of mutations will be described. The rate will be given as percentage of patients developing mutations.
Other	Vascular biology substudy: analysis of clinical and laboratory vascular and metabolic risk factors	baseline, at months 6, 12 and 24	Ankle Brachial Index (ABI) will be prospectively evaluated followed by analysis of various biomarkers for vascular damage
Other	Pharmacokinetic (PK), pharmacodynamic (PD) substudy	at day 1, months 1, 2, 3, 12, 18, 24	It is planned to analyze PK parameters sequentially by taking serum from PB and subsequent HPLC-MS/MS technology. Pharmacodynamics in different compartments will be analyzed by means of flow-cytometry of PB and BM samples.
Other	Telomere substudy	at months 1, 2, 3, 12 and 24	Assessment of telomere length in normal and leukemic cells as potential new biomarker for prognosis, prediction of response under Bosutinib
Other	Ultra-deep next-generation sequencing (UD-NGS)	at months 1, 2, 3, 12 and 24	Documentation of subclone evolution or elimination during Bosutinib treatment
Other	Assessment of patients comorbidities and correlation to individual patient´s adverse side effect profile substudy	through study completion, an average of 2 years	Documentation of patient´s comorbidity profile using 3 different comorbidity scales
Other	Transport mechanisms of Bosutinib and mechanisms of diarrhea substudy	every 14 days month 1-3	Investigation the role of the 5-HT pathway in directing bosutinib induced diarrhea by assessment of 5-HT and certain cytokine levels and genetic analysis including SNP and GWAS

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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