Follicular LymphomaNCT05899621
A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL
An observational study of Follicular Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Obinutuzumab, Lenalidomide and Bendamustine
- Type of treatment
- Injection or infusion
- How many people
- 332 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients age ≥18 years with grade 1 to 3a FL.
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pengpeng Xu, PhD，MD contact
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, M.D. and Ph.D, zhao.weili@yahoo.com
About this study
Official title: A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma
This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma
Read the 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.
- Conditions
- Follicular Lymphoma
- Being tested
- Obinutuzumab, Lenalidomide, Bendamustine, Cyclophosphamide, Doxorubicin
- Keywords
- obinutuzumab, Lymphoma
- Medical subject headings
- Lymphoma, Follicular, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
LenalidomideDrug
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
BendamustineDrug
Bendamustine IV infusion will be administered as per the schedule specified in the respective arm.
CyclophosphamideDrug
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DoxorubicinDrug
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
VincristineDrug
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
PrednisoneDrug
Prednisone PO will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Obinutuzumab; Drug: 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 Receives: Drug: Obinutuzumab; Drug: 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 Receives: Drug: Obinutuzumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Secondary outcomes (3)
Complete response rate (CR)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Progression free survival
Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Duration of response
Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili Zhao, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899621
- Sponsor's protocol ID
- FL-Gbased
- Status last verified
- Jun 2023
- First submitted
- 1 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT05899621
- Acronym / sponsor ID
- FL-Gbased
- Conditions
- Follicular Lymphoma
- Keywords
- obinutuzumab, Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GR | – | Drug: Obinutuzumab, Drug: LenalidomideInduction(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 | – | Drug: Obinutuzumab, Drug: BendamustineInduction(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 | – | Drug: Obinutuzumab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: PrednisoneInduction(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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients age ≥18 years with grade 1 to 3a FL.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObinutuzumabObinutuzumab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | GB, GCHOP, GR |
| LenalidomideLenalidomide PO will be administered as per the schedule specified in the respective arm. | Drug | GR |
| BendamustineBendamustine IV infusion will be administered as per the schedule specified in the respective arm. | Drug | GB |
| CyclophosphamideCyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. | Drug | GCHOP |
| DoxorubicinDoxorubicin IV infusion will be administered as per the schedule specified in the respective arm. | Drug | GCHOP |
| VincristineVincristine IV infusion will be administered as per the schedule specified in the respective arm. | Drug | GCHOP |
| PrednisonePrednisone PO will be administered as per the schedule specified in the respective arm. | Drug | GCHOP |
Primary outcome
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
3 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pengpeng Xu, PhD，MD contact
Weili Zhao study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao, +862164370045 (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.