Robak (2024)
Chronic lymphocytic leukemia
Oncology • Other Data • Czech Republic, France
Study Metrics
Total Sample
811
Treatment Group
119
Control Group
692
Covariates
18
PICO Comparisons
1
Quality Indicators
Transparency
High
DAG Usage
No
QBA Performed
No
Study Information
| First Author: | Robak |
| Publication Year: | 2024 |
| DOI: | https://doi.org/10.1080/03007995.2024.2368175 |
| Preprint: | No preprint |
Institution & Funding
| Institutions: | Medical University of Lodz, University Hospital Brno, Hôpital Lyon-Sud, Janssen Pharmaceutica NV, UAB "JOHNSON & JOHNSON", Janssen-Cilag GmbH, Janssen Sciences Ireland UC, Pharmacyclics |
| Funding: | Declared: Private |
| Funding Institutions: | The study was funded by Janssen Pharmaceutica NV and Pharmacyclics LLC, an AbbVie Company. The real-world databases in France and the Czech Republic (Lyon-Sud and CLLEAR) that were utilized are not owned by Janssen Pharmaceutica NV. |
Study Context
| Disease: | Chronic lymphocytic leukemia |
| Disease Category: | Oncology |
| Data Type: | Other |
| Number of Data Sources: | 2 |
| Geography: | Czech Republic, France |
| Eligible Sample: | 1360.0 |
| Number of Emulations: | 3 |
| Number of Treatments: | 2 |
Analytical Methods
| Matching Method: | PS matching |
| Analysis Method: | Cox PH |
Quality Methods
Directed Acyclic Graph (DAG)
Not Used
Quantitative Bias Analysis (QBA)
Not Performed
Target Trial Information
| Target Trial Name: | RESONATE-2 |
| Registration Number: | NCT01722487 |
| Target Trial DOI: | https://doi.org/10.1056/nejmoa1509388, https://doi.org/10.3324/haematol.2018.192328 |
TTE vs RCT Comparisons
Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.
Overall survival
RESONATE-2
HR
Efficacy
Population
Adult patients with chronic lymphocytic leukemia (CLL)
Intervention
First-line (1L) ibrutinib monotherapy
Comparison
First-line chemotherapy/chemoimmunotherapy (CT/CIT) followed by second-line (2L) ibrutinib after disease progression
Outcome
Overall survival
RCT Result
0.35
95% CI: [0.20, 0.62]
vs
TTE Result
0.64
95% CI: [0.39, 1.04]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Same Direction
Both point to similar conclusion
Both point to similar conclusion
Transparency Indicators
Protocol Registration
Available
Data Sharing
Not Available
Code Sharing
Not Available
Overall Transparency Score:
High Transparency - This study meets good transparency standards.
Conflicts & Funding
| Conflicts of Interest: | Declared: Financial |
| COI Institutions: | Janssen, AbbVie, AstraZeneca, BeiGene, Lilly, AOP Orphan, Gilead |
| Funding Source: | Declared: Private |
| Funding Institutions: | The study was funded by Janssen Pharmaceutica NV and Pharmacyclics LLC, an AbbVie Company. The real-world databases in France and the Czech Republic (Lyon-Sud and CLLEAR) that were utilized are not owned by Janssen Pharmaceutica NV. |