Clinical trial · Observational
A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL
A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma
NCT05899621CI-TRIAL-00067096recruitingClinicalTrials.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 aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- GR
- description
- 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
- interventionNames
- Drug: Obinutuzumab
- Drug: Lenalidomide
- label
- GB
- description
- 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
- interventionNames
- Drug: Obinutuzumab
- Drug: Bendamustine
- label
- GCHOP
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Transformed follicular lymphoma or 3B follicular lymphoma; * HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive * Central nervous system or meninges involved * Any drug contraindication in the treatment plan * Patients judged by other researchers to be unsuitable for inclusion in the study
References
Publications (0)
Data not yet available
No reference posted for this study.