N/A
N=260
Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE)
Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02316613 ↗Enrolled (actual)
260
Serious AEs
38.7%
Results posted
Feb 2016
Primary outcome: Primary: Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase — 81.9; 8.4; 6.3; 3.4 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
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase |
81.9; 8.4; 6.3; 3.4 | — |
| PRIMARY Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase |
47.7; 21.2; 19.5; 11.2; 2.9; 2.5 | — |
| PRIMARY Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase |
45.9; 44.3; 32.0; 13.1; 10.7; 23.8 | — |
| PRIMARY Percentage of Participants With MabThera as Maintenance Therapy |
63.2 | — |
| PRIMARY Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase |
70.9; 1.6; 27.6 | — |
| PRIMARY Duration of MabThera Maintenance Therapy When Associated With Observation |
24.5 | — |
| PRIMARY Percentage of Participants With Prescription of Injection Prophylaxis |
39.3 | — |
| PRIMARY Percentage of Participants With Injection Prophylaxis Treatment |
65.8; 83.5; 26.9 | — |
| PRIMARY Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression |
80.0; 67.5; 17.1; 20.0; 2.9; 10.0 | — |
| PRIMARY Number of Participants With Therapeutic Management After the First Study Disease Progression |
2; 4; 24; 29; 24; 27 | — |
| SECONDARY Percentage of Participants With Last Induction Treatment Response |
38.3; 11.5; 31.7; 6.2; 5.3; 7.0 | — |
| SECONDARY Percentage of Participants With Number of Disease Progressions |
52.7; 68.5; 39.22; 22.0; 6.8; 6.3 | — |
| SECONDARY Percentage of Participants With Disease Characteristics at First Study Disease Progression |
3.1; 5.3; 50.0; 42.1; 46.9; 52.6 | — |
| SECONDARY Progression Free Survival (PFS) |
44.4 | — |
| SECONDARY Time to Next Treatment |
NA | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Number of Participants Who Used MabThera |
230; 127; 205; 127; 89; 125 | — |
| SECONDARY MabThera Regimen: Dose of MabThera |
661.25; 671.15 | — |
| SECONDARY MabThera Regimen: Infusion Duration |
168.60; 150.25 | — |
| SECONDARY MabThera Regimen: Number of Cycles of MabThera |
4.8; 7.6 | — |
| SECONDARY MabThera Regimen: Time Between Cycles |
23.79; 80.60 | — |
| SECONDARY Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase |
6.5; 93.5; 41.3; 58.7; 36.4; 63.6 | — |
| SECONDARY Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score |
22.14; 17.67; 17.30; 15.32; 45.92; 118.11 | — |
| SECONDARY Number and Type of Hospitalization Associated With MabThera Perfusion |
727; 934; 308; 15; 0; 2 | — |
Summary
This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance therapy. Actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.
Eligibility Criteria
Inclusion Criteria
- Adult patient (age >/= 18 years)
- Presenting with WHO grade 1-3, CD20-positive follicular non-Hodgkin's lymphoma, histologically confirmed at initial diagnosis
- In relapse (or refractory) after at least one line of treatment, regardless of the nature of previous treatments (chemotherapy and/or immunotherapy and/or radioimmunoconjugate therapy and/or radiation+chemotherapy) and for whom a decision was made to give salvage therapy
- Having received oral and written information about the study and having raised no objections to electronic capture and processing of his/her personal data
Exclusion Criteria
- Patient participating in a clinical trial evaluating a new, non-commercialized cancer treatment at the time of inclusion
- Follicular lymphoma presenting with a transformation to diffuse large cell non-Hodgkin's lymphoma
- First line treatment with radiotherapy alone
- Initial abstention from treatment (decision to not treat the progression at the time of inclusion in the OLYMPE study)
Data sourced from ClinicalTrials.gov (NCT02316613). 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.