Trial · NCT04793399
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Profile of Bosutinib 400 mg Daily in Combination With Atezolizumab in Participants With Chronic Myeloid Leukemia as First Line Treatments | through study completion, up to 7 months | All Adverse Events, despite their severity or causal relationship with the study medication, will be reported, graded according CTCAE v5.0 and analyzed. |
| Secondary | To Evaluate the Molecular Response (MR) Rates | 7 months | Ratio of patients that reach a Molecular response |
| Secondary | Percentage of Participants Alive | 7 months | Percentage of patients that remain alive at different time-points over the total number or patients |
| Secondary | Number of Confirmed MR4 and MR4.5 | 7 months | Total number of patients that reach Molecular response 4 (MR4) and Molecular Response 4.5 (MR4.5) |
| Secondary | The Rate of Confirmed MR4 and MR4.5 | 7 months | Ratio of patients that reach MR4 and MR4.5 |
| Secondary | Number of Complete Cytogenetic Responses (CCyR) | 7 months | Number of patients that reach a Complete Cytogenetic Responses (CCyR) |
| Secondary | The Rate of Complete Cytogenetic Response (CCyR) | 7 months | Ratio of patients that reach a Complete Cytogenetic Responses (CCyR) |
| Secondary | Days to Response (CCyR, MMR, MR4, MR4.5) | 7 months | Number of days lasted since the beginning of the treatment upt to reach molecular response. |
| Secondary | The Median Time to Response (CCyR, MMR, MR4, MR4.5) | 7 months | Average elapsed time measured for all included patients since the beginning of the treatment up until reach measurable cytogenetic or molecular response |
| Secondary | Probability of Response (CCyR, MMR, MR4, MR4.5) | 7 months | The overall estimated probability of reaching complete cytogenetic response or molecular response MMR, MR4 or MR4.5 |
| Secondary | Number of Overall Surviving Patients | 7 months | Number of the overall surviving patients |
| Secondary | Number of Progression-free Survival Patients | 7 months | The following events are considered disease progression: * Acelerated Phase. * Blast Crisis. * CML-related death. |
| Secondary | Number of Failure-free Survival Patients | 7 months | Number of the failure-free survival patients |
| Secondary | Number of Event-free Survival Patients | 7 months | Number of the event-free survival patients |
| Secondary | Phenotypical Assays of Cell Characterization | 7 months | Phenotypical assays of the cell characterization |
| Secondary | Phenotypical Assays of Differentiation, Maturation and Proliferation NK Cells Markers | 7 months | Phenotypical assays of the differentiation, maturation and proliferation NK cells markers |
| Secondary | Phenotypical Assays of CD4+ T Cells Activation Markers | 7 months | Phenotypical assays of the CD4+ T cells activation markers |
| Secondary | Phenotypical Assays of Predictive Markers of CML Relapse | 7 months | Phenotypical markers assessment for relapse included 1. Cell characterization: NK cells (CD3- CD56+; CD16+ CD56+; TNFα; IFNα; Granzyme b NK-LGL cells (CD56+ CD57+), T-LGL cells (CD3+ CD57+), CD8 TCRα/β, NK markers (NKG2D, KIR2DL2/DL3/DS2, KIR2DL5B). 2. Differentiation and maturation (NKG2A/CD16) and proliferation (NK67) markers of NK cells. 3. CD4+ T cells activation markers: CD25 CD69 HLA-DR. 4. Predictive markers of CML relapse: T regs (CD4+ CD25int-hi CD127low), CD8+ T cells (PD-1/PD-L1) and plasmacytoid dendritic cells (CD86+). |
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.
For software
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