N/A
N=67
A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia
Lymphocytic Leukemia, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01609023 ↗Enrolled (actual)
67
Serious AEs
49.3%
Results posted
Jun 2017
Primary outcome: Primary: Percentage of Participants With Adverse Events (AEs) — 89.6 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
89.6 | — |
| SECONDARY Progression-Free Survival (PFS) Assessed Using Local Standards |
NA | — |
| SECONDARY Percentage of Participants With Disease Progression or Death Assessed Using Local Standards |
5.8; 11.1; 17.5; 14.7 | — |
| SECONDARY Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards |
84; 72.1; 58.5; 67.6 | — |
| SECONDARY Percentage of Participants With CR Assessed Using Local Standards |
42; 41.8; 37.5; 44.1 | — |
| SECONDARY Percentage of Participants With PR Assessed Using Local Standards |
42; 30.2; 22.5; 23.5 | — |
| SECONDARY Time to Progression (TTP) Assessed Using Local Standards |
NA | — |
Summary
This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.
Eligibility Criteria
Inclusion Criteria
- Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC
Exclusion Criteria
- Contraindications to rituximab therapy according to the approved SPC
Data sourced from ClinicalTrials.gov (NCT01609023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.