Clinical trial · Observational
Rituximab Therapy in Follicular Lymphoma in Combination With Chemotherapy - REFLECT 1
Open, Noninterventional, Multicentre Trial of Rituximab in Combination With Chemotherapy (CVP, CHOP or FCM) Chemotherapy in Patients With Follicular Lymphoma
NCT02461290CI-TRIAL-00019263completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Radiation | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Combination Therapy
- description
- Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens.
- interventionNames
- Radiation: Chemotherapy
- Drug: Rituximab
Primary outcomes (1)
- measure
- Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE
- timeFrame
- Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
- description
- The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.