Clinical trial · Interventional
A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA
NCT02213263CI-TRIAL-00039149completedPhase 3Results 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)
This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.
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)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PF-05280586
- interventionNames
- Biological: PF-05280586
- type
- ACTIVE_COMPARATOR
- label
- MabThera®
- interventionNames
- Biological: MabThera®
Primary outcomes (1)
- measure
- Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
- timeFrame
- Week 26
- description
- ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with the revised response criteria for malignant lymphoma (Cheson 2007). CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma * Ann Arbor Stage II, III, or IV Exclusion Criteria: * Not a candidate for treatment with rituximab as a single-agent * Evidence of transformation to a high grade or diffuse large B-cell lymphoma * Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy, or steroids * Any prior treatment with rituximab * Active, uncontrolled infection
References
Publications (2)
- DERIVEDCourville J, Nastoupil L, Kaila N, Kelton J, Zhang J, Alcasid A, Nava-Parada P. Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar. BioDrugs. 2021 Jul;35(4):459-468. doi: 10.1007/s40259-021-00487-6. Epub 2021 Jun 21. PMID 34152584
- DERIVEDSharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I. A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera(R)) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs. 2020 Apr;34(2):171-181. doi: 10.1007/s40259-019-00398-7. PMID 31820339