Studies obinutuzumab-based treatment for untreated follicular lymphoma
Observes how obinutuzumab-based therapy works and its safety in adults newly diagnosed with follicular lymphoma.
Key facts
- Who runs it
- Ruijin Hospital
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL
- Status
- Recruiting
- People taking part
- 332 people, planned
- Started
- 1 Jun 2023
- Expected to end
- 30 Jun 2027
- Type of study
- Observational, 3 groups
- Treatments tested
- Obinutuzumab
- Lenalidomide
- Bendamustine
- Cyclophosphamide
- Doxorubicin
- Vincristine
- Prednisone
- Record updated
- 12 June 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with follicular lymphoma who have never been treated and need treatment now. They would receive an obinutuzumab-based therapy.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- CD20 positive follicular lymphoma, grade 1, 2 or 3A, confirmed by tissue examination. Treatment is needed, and a lesion that can be measured on CT or PET-CT before treatment.
- Earlier treatment
- No earlier treatment for the lymphoma. The doctor must consider the GR, GB or GCHOP regimens appropriate.
- Biomarker or test result
- CD20 positive lymphoma.
Main reasons for not taking part
- Transformed follicular lymphoma or grade 3B follicular lymphoma
- Positive hepatitis B or hepatitis C tests with virus detected, or HIV positive
- Lymphoma in the brain, spinal cord or their coverings
- Any drug that cannot be used in the treatment plan
- Judged unsuitable for the study by other researchers
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
- Treatment naive
- Age ≥ 18 years
- Indications for treatment confirmed
- Must has measurable lesion in CT or PET-CT prior to treatment
- Considered suitable for GR, GB or GCHOP regimens
- Informed consented
Who cannot take part
- Any drug contraindication in the treatment plan
- HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
- Transformed follicular lymphoma or 3B follicular lymphoma
- Central nervous system or meninges involved
- Patients judged by other researchers to be unsuitable for inclusion in the study
Where in China
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaContact: Weili Zhao, M.D. and Ph.DTaking people
About the trial
What the trial wants to find out
This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma
The 3 groups in the trial
- GR
Induction(six 21-day cycles): obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-6); lenalidomide (R), 25mg, PO, D2-11; Maintenance: obinutuzumab (G), 1000mg, every 3 months for 2 years; lenalidomide (R), 25mg, PO, D1-10, every 28 days for 6 cycles
Treatment: Obinutuzumab and Lenalidomide
- GB
Induction(six 21-day cycles): obinutuzumab (G) 1000mg, IV, D1/8/15 (C1), D1 (C2-6); bendamustine (B), 90 mg/m2, IV, D1-2; Maintenance: obinutuzumab (G), 1000mg, IV, every 3 months for 2 years
Treatment: Obinutuzumab and Bendamustine
- GCHOP
Induction(six 21-day cycles): obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-6); prednisone (P), 100 mg, PO, D1-5；cyclophosphamide (C), 750 mg/m2, IV, D1; vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D1; doxorubicin (H), 50 mg/m2, IV, D1; Maintenance: obinutuzumab (G), 1000mg, IV, every 3 months for 2 years
Treatment: Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma
- Plain-language title
- Studies obinutuzumab-based treatment for untreated follicular lymphomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 June 2023