Trial · NCT03205267
Phase II Study Testing the Tolerability and the Efficacy of Bosutinib in Chronic Phase CML Patients
NCT03205267, Phase 2, Unknown, University of Bonn
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study Testing the Tolerability and the Efficacy of Bosutinib in Chronic Phase CML Patients. Trials, record NCT03205267. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03205267
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study Testing the Tolerability and the Efficacy of Bosutinib in Chronic Phase CML Patients
- NCT number
- NCT03205267
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 127 participants, estimated
- Lead sponsor
- University of Bonn
- Conditions
- Chronic Myelogenous Leukaemia
- Interventions
- Bosulif
- First posted
- 2017-07-02
- Last updated
- 2017-07-02
- Other registries' IDs
- eudract:2014-005531-13
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03205267
GET https://conductscience.org/api/trials/v1/NCT03205267/registered