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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02213263
• Date of registration: 07/08/2014
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: 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)
• Scientific title: 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
• Date of first enrolment: September 30, 2014
• Target sample size: 394
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02213263
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Austria, Belarus, Belgium, Brazil, Croatia, France, Georgia, Germany, Greece, India, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Switzerland, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Follicular Lymphoma

Intervention(s)

Biological: PF-05280586

Biological: MabThera®

Primary Outcome(s)

Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26 [Time Frame: Week 26]

Secondary Outcome(s)

Progression-Free Survival (PFS) [Time Frame: From randomization until disease progression or death due to any cause or up to Week 52]

Percentage of Participants With Complete Remission (CR) at Week 26 [Time Frame: Week 26]

Number of Participants With Clinically Significant Laboratory Abnormalities [Time Frame: Baseline up to Week 52]

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to Week 52]

Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU [Time Frame: Predose (within 4 hours prior to start of infusion) on Days 1, 8, 15 and 22; within 15 minutes prior to end of infusion on Days 1 and 22]

Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 [Time Frame: Baseline up to Week 52]

Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to Week 52]

Number of Participants Reporting Immune-Based Adverse Effects [Time Frame: Baseline up to Week 52]

Time to Treatment Failure (TTF) [Time Frame: From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52]

Cluster of Differentiation (CD) 19-Positive B-Cell Counts [Time Frame: Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52]

Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU [Time Frame: Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22]

Duration of Response (DOR) [Time Frame: From date of first documentation of overall response to first documentation of PD or to death due to any cause in absence of PD or up to Week 52]

Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 [Time Frame: Baseline up to Week 52]

Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) [Time Frame: Baseline up to Week 52]

Overall Survival [Time Frame: From randomization until death due to any cause or up to Week 52]

Secondary ID(s)

REFLECTIONS

2014-000132-41

B3281006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02213263