---
title: A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL
nct_id: NCT05899621
overall_status: RECRUITING
sponsor: Ruijin Hospital
study_type: OBSERVATIONAL
primary_condition: Follicular Lymphoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05899621.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05899621"
ct_last_update_post_date: 2023-06-12
last_seen_at: "2026-05-12T07:26:55.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL

**Official Title:** A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma

**NCT ID:** [NCT05899621](https://clinicaltrials.gov/study/NCT05899621)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 332
- **Lead Sponsor:** Ruijin Hospital
- **Conditions:** Follicular Lymphoma
- **Start Date:** 2023-06-01
- **Completion Date:** 2027-06-30
- **CT.gov Last Update:** 2023-06-12

## Brief Summary

This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma

## Detailed Description

This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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
- **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
- **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

## Interventions

- **Obinutuzumab** (DRUG) — Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
- **Lenalidomide** (DRUG) — Lenalidomide PO will be administered as per the schedule specified in the respective arm.
- **Bendamustine** (DRUG) — Bendamustine IV infusion will be administered as per the schedule specified in the respective arm.
- **Cyclophosphamide** (DRUG) — Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
- **Doxorubicin** (DRUG) — Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
- **Vincristine** (DRUG) — Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
- **Prednisone** (DRUG) — Prednisone PO will be administered as per the schedule specified in the respective arm.

## Primary Outcomes

- **Objective response rate (ORR)** _(time frame: End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days])_ — Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria

## Secondary Outcomes

- **Complete response rate (CR)** _(time frame: End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days])_
- **Progression free survival** _(time frame: Baseline up to data cut-off (up to approximately 2 years))_
- **Duration of response** _(time frame: Baseline up to data cut-off (up to approximately 2 years))_

## Locations (1)

- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ruijin hospital, shanghai jiao tong university school of medicine|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05899621.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05899621*  
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