N/A
N=681
A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
Lymphocytic Leukemia, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01178086 ↗Enrolled (actual)
681
Serious AEs
18.9%
Results posted
Oct 2018
Primary outcome: Primary: Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate — 50.6; 33.7 months
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
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate |
50.6; 33.7 | — |
| PRIMARY Percentage of Participants Without Progression or Death |
71.1; 62.7 | — |
| SECONDARY Percentage of Participants With Progression and Death |
68.9; 66.7; 31.1; 33.3 | — |
| SECONDARY Percentage of Participants Who Received Each Treatment During the Course of Study |
58.5; 64.0; 56.8; 60.3; 60.0; 67.8 | — |
| SECONDARY Mean Body Weight |
77.4; 75.0; 77.4; 73.7; 77.0; 73.3 | — |
| SECONDARY Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status |
36.4; 23.8; 23.9; 19.0; 34.0; 26.2 | — |
| SECONDARY Percentage of Participants With Karnofsky Performance Status Index |
25.4; 7.4; 14.8; 7.9; 17.5; 11.0 | — |
| SECONDARY Percentage of Participants With General Symptoms |
38.1; 45.0; 23.5; 22.8; 17.8; 14.5 | — |
| SECONDARY Percentage of Participants With B-Symptoms |
4.0; 4.8; 3.4; 2.6; 2.2; 0.7 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) |
37.9; 32.8; 37.3; 39.2; 8.1; 8.5 | — |
Summary
This observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL.
Eligibility Criteria
Inclusion Criteria
- CLL requiring treatment
- Participants receiving a chemotherapy in combination with rituximab (decision taken by doctor prior to and independent from inclusion in this non-interventional study)
- After this trial started, an amendment to the study protocol was introduced, adding a further inclusion criterion: Comorbidities according to cumulative illness rating scale (CIRS) score greater than (>) 6 and/or creatinine clearance less than (<) 70 milliliters per minute (mL/min)
Exclusion Criteria
- Participants with contraindication to rituximab treatment
Data sourced from ClinicalTrials.gov (NCT01178086). 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.