N/A
N=99
Rituximab Therapy in Follicular Lymphoma in Combination With Chemotherapy - REFLECT 1
Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02461290 ↗Enrolled (actual)
99
Serious AEs
10.1%
Results posted
Sep 2015
Primary outcome: Primary: Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE — 34; 10; 7 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Chemotherapy (Radiation); Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE |
34; 10; 7 | — |
| SECONDARY Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL) |
73.2 | — |
| SECONDARY Percentage of Participants With CR According to International Working Group Response Criteria for NHL |
61.6 | — |
| SECONDARY Percentage of Participants Alive at 1, 2, and 3 Years |
94.2; 92.6; 92.6 | — |
Summary
The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.
Eligibility Criteria
Inclusion Criteria
- New diagnosed Stage III/IV NHLs
- Grades 1, 2 follicular lymphoma need to be treated
- mCD20 positive
- Have an expected survival of 3 months or more
- ECOG 0-2 grade
- Normal renal function
- ALT less than double normal level
Exclusion Criteria
- Presence of CNS lymphoma
- Severe infectious disease or organic disease
- Having another malignant tumor
- Pregnant or breast-feeding female
- Organic heart disease, heart failure, II or higher grade AV bundle block.
- Subject is allergic to Rituximab
- Known HIV infection or chronic HBV infection
Data sourced from ClinicalTrials.gov (NCT02461290). 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.