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)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Follicular Lymphoma

Treatments: Biological: MabThera®; Biological: PF-05280586

Study type: Interventional

Funder types: Industry

Identifiers

NCT02213263

2014-000132-41 (EudraCT Number)

B3281006

REFLECTIONS (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 394 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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394 participants in 2 patient groups

PF-05280586

Experimental group

Treatment:

Biological: PF-05280586

MabThera®

Active Comparator group

Treatment:

Biological: MabThera®