Trial · NCT04793399
Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients
NCT04793399, Phase 1, Phase 2, Terminated, Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica; results first posted 2024-03-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients. Trials, record NCT04793399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04793399
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients
- NCT number
- NCT04793399
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica
- Conditions
- Chronic Phase-Chronic Myeloid Leukemia
- Interventions
- Bosutinib 400 MG Monotherapy, Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection
- First posted
- 2021-03-11
- Last updated
- 2024-03-19
- Results first posted
- 2024-03-12
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol for safety reasons were reached. Therefore no sufficient data were obtained to conduct an efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. | Total No Adverse events recorded | NUMBER |
| SECONDARY | To Evaluate the Molecular Response (MR) Rates | 7 months | The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants). | ||
| SECONDARY | Percentage of Participants Alive | 7 months | The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants). | ||
| SECONDARY | Number of Confirmed MR4 and MR4.5 | 7 months | The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants). | ||
| SECONDARY | The Rate of Confirmed MR4 and MR4.5 | 7 months | The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants). | ||
| SECONDARY | Number of Complete Cytogenetic Responses (CCyR) | 7 months | The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants). | ||
| SECONDARY | The Rate of Complete Cytogenetic Response (CCyR) | 7 months | The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants). | ||
| SECONDARY | Days to Response (CCyR, MMR, MR4, MR4.5) | 7 months | The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants). | ||
| SECONDARY | The Median Time to Response (CCyR, MMR, MR4, MR4.5) | 7 months | The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants). | ||
| SECONDARY | Probability of Response (CCyR, MMR, MR4, MR4.5) | 7 months | The study had to be prematurely terminated due to drug toxicity; the stopping rules detailed in the protocol were reached. Therefore no sufficient data were obtained to conduct the planned efficacy analysis. No study subjects could be analysed for any of the efficacy outcomes. Study has to be prematurely terminated and the analysis could not be done due to lack of data (n=0 Participants). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Profile of Bosutinib 400 mg Daily in Combination With Atezolizumab in Participants With Chronic Myeloid Leukemia as First Line Treatments | Bosutinib-Atezolizumab Combination | 55 | Total No Adverse events recorded |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bosutinib-Atezolizumab Combination | 9 | |
| Overall Study | COMPLETED | Bosutinib-Atezolizumab Combination | 4 | |
| Overall Study | NOT COMPLETED | Bosutinib-Atezolizumab Combination | 5 |
Source ClinicalTrials.gov
Adverse events17
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Bosutinib-Atezolizumab Combination | 7 | 9 | 10 |
| other | Vomiting | Gastrointestinal disorders | Bosutinib-Atezolizumab Combination | 3 | 9 | 5 |
| other | Nausea | Gastrointestinal disorders | Bosutinib-Atezolizumab Combination | 4 | 9 | 4 |
| other | Abdominal discomfort | Musculoskeletal and connective tissue disorders | Bosutinib-Atezolizumab Combination | 1 | 9 | 1 |
| other | Abdominal pain | Musculoskeletal and connective tissue disorders | Bosutinib-Atezolizumab Combination | 1 | 9 | 1 |
| other | Abdominal pain upper | Musculoskeletal and connective tissue disorders | Bosutinib-Atezolizumab Combination | 1 | 9 | 1 |
| other | Blood bilirubin increased | Hepatobiliary disorders | Bosutinib-Atezolizumab Combination | 1 | 9 | 1 |
| other | Headache | Nervous system disorders | Bosutinib-Atezolizumab Combination | 1 | 9 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Bosutinib-Atezolizumab Combination | 1 | 9 | 1 |
| other | Pyrexia | General disorders | Bosutinib-Atezolizumab Combination | 1 | 9 | 1 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosutinib-Atezolizumab Combination | 0 | 9 |
| Total, other adverse events | Bosutinib-Atezolizumab Combination | 9 | 9 |
| Total, serious adverse events | Bosutinib-Atezolizumab Combination | 4 | 9 |
Source ClinicalTrials.gov
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/NCT04793399
GET https://conductscience.org/api/trials/v1/NCT04793399/registered