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)
Completed · Phase 3
Conditions studied: Follicular Lymphoma
In brief
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.
Key facts
- Study ID
- NCT02213263
- Run by
- Pfizer
- People needed
- 394
- Starts
- 2014-09-30
- Expected to finish
- 2018-04-19
- Last updated by the study team
- 2019-06-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma
- Ann Arbor Stage II, III, or IV
You may not qualify if…
- 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
Where it is running
- The Oncology Institute of Hope and Innovation — Anaheim, California, United States
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc. — Corona, California, United States
- The Oncology Institute of Hope and Innovation — Downey, California, United States
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc. — Fountain Valley, California, United States
- Global Cancer Research Institute (GCRI), Inc — Gilroy, California, United States
- Saint Louise Regional Hospital Radiology Department (Radiology Only) — Gilroy, California, United States
- South Valley Imaging Center (Imaging Only) — Gilroy, California, United States
- Los Angeles Hematology Oncology Medical Group — Glendale, California, United States
- The Oncology Institute of Hope and Innovation — Glendale, California, United States
- Los Angeles Hematology Oncology Medical Group — Glendale, California, United States
- The Oncology Institute of Hope and Innovation — Long Beach, California, United States
- Los Angeles Hematology Oncology Medical Group — Los Angeles, California, United States
- Los Angeles Hematology Oncology Medical Group — Los Angeles, California, United States
- The Oncology Institute of Hope and Innovation — Lynwood, California, United States
- The Oncology Institute of Hope and Innovation — Montebello, California, United States
- Comprehensive Cancer Center at Desert Regional Medical Center — Palm Springs, California, United States
- Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates — Redondo Beach, California, United States
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc. — Riverside, California, United States
- Global Cancer Research Institute, Inc. — San Jose, California, United States
- O'Connor Hospital — San Jose, California, United States
- PET Imaging of San Jose (Imaging Only) — San Jose, California, United States
- The Oncology Institute of Hope and Innovation — Santa Ana, California, United States
- Torrance Memorial Medical Center — Torrance, California, United States
- The Oncology Institute of Hope and Innovation — Whittier, California, United States
- Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.