N/A
N=489
Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02536664 ↗Enrolled (actual)
489
Serious AEs
15.1%
Results posted
Nov 2015
Primary outcome: Primary: Percentage of Participants Who Were Alive and Free From Progressive Disease — 88.28; 76.03 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
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Were Alive and Free From Progressive Disease |
88.28; 76.03 | — |
| SECONDARY Median Progression Free Survival (PFS) Time |
NA; NA | — |
| SECONDARY Percentage of Participants Who Were Alive |
96.89; 95.44 | — |
| SECONDARY Median Overall Survival (OS) Time |
NA; NA | — |
| SECONDARY Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy |
58.4; 51.2; 21.0; 20.9; 12.1; 9.3 | — |
| SECONDARY Percentage of Participants With Best Overall Response |
98.4; 96.5 | — |
| SECONDARY Percentage of Participants With Initiation of New Therapy |
16.7; 11.6; 75.7; 69.2; 7.5; 19.2 | — |
Summary
It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.
Eligibility Criteria
Inclusion Criteria
- Age over 18 years
- Previously untreated, relapsed or refractory CD 20-positive FL
- Responding to rituximab containing induction therapy (complete response [CR] or partial response [PR])
- To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
- No ineligibility for rituximab
Exclusion Criteria
Not Applicable (NA)
Data sourced from ClinicalTrials.gov (NCT02536664). 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.