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Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients
Phase 1, PHASE2 trial testing Bosutinib 400 MG Monotherapy in Chronic Phase-Chronic Myeloid Leukemia in 9 participants. Terminated before completion.
| Lead sponsor | Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 24 February 2021 |
| Primary completion | 24 September 2021 |
| Estimated completion | 24 September 2021 |
| Sites | 2 locations across Spain |
Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica — full company profile →
18 and older, any sex, with Chronic Phase-Chronic Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
All Adverse Events, despite their severity or causal relationship with the study medication, will be reported, graded according CTCAE v5.0 and analyzed.
| Group | Value | 95% CI |
|---|---|---|
| Bosutinib-Atezolizumab Combination | 55 |
Time frame: Study Period: start (first patient enrolled) 24/02/2021 and premature end (Last patient last visit) 24/09/2021. Therefore, 7 months was the duration of this study and in this period of time when adverse event data were collected.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Bosutinib-Atezolizumab Com… |
|---|---|---|
| Hepatotoxicity | Hepatobiliary disorders | — |
| Cholestasis | Hepatobiliary disorders | — |
| Transaminases Elevation | Hepatobiliary disorders | — |
| Reaction | System | Bosutinib-Atezolizumab Com… |
|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Abdominal discomfort | Musculoskeletal and connective tissue disorders | — |
| Abdominal pain | Musculoskeletal and connective tissue disorders | — |
| Abdominal pain upper | Musculoskeletal and connective tissue disorders | — |
| Blood bilirubin increased | Hepatobiliary disorders | — |
| Headache | Nervous system disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Pyrexia | General disorders | — |
| Lipase increased | Metabolism and nutrition disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Alanine aminotransferase increased | Hepatobiliary disorders | — |
| Aspartate aminotransferase increased | Hepatobiliary disorders | — |
Most-reported serious reactions: Hepatotoxicity, Cholestasis, Transaminases Elevation.
Data from ClinicalTrials.gov NCT04793399 adverse events section.
The combination of bosutinib plus atezolizumab in first line treatment in newly diagnosis chronic-phase Chronic Myeloid Leukemia (CML) patients could potentially increase molecular responses and therefore treatment discontinuation probabilities in these patients. We propose an Open-Label Phase Ib/II Study of Bosutinib in Combination with Atezolizumab for the Treatment of New Diagnosis Chronic Phase-Chronic Myeloid Leukemia Patients.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04793399.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing