Follicular Lymphoma Grade 3APhase 2PROOFNCT06961500
Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A
A Phase 2 study testing Obinutuzumab, CHOP and Bendamustine in people with Follicular Lymphoma Grade 3A, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a multicenter, phase 2, randomized trial to evaluate the efficacy and safety of obinutuzumab with CHOP versus obinutuzumab with bendamustine in treatment-naïve follicular lymphoma (Grade 3A) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma Grade 3A
- What is being tested?
- Obinutuzumab, CHOP and Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 Nov 2030
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically confirmed follicular lymphoma Grades 3A, CD20 positive by immunohistochemistry.
- Meets at least one GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria.
- No prior systemic treatment for lymphoma.
- Presence of measurable lesions.
- Age ≥ 18 years, no gender restriction.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Expected survival of > 3 months.
- Adequate organ and bone marrow function.
Who cannot join
- History of allergy to any component of monoclonal antibodies or investigational drugs.
- Central nervous system involvement.
- History of previous malignant tumors.
- History of active bleeding or bleeding tendencies, or requiring anticoagulant medication.
- Requirement for potent CYP3A4 inhibitors for treatment.
- Active infection, except for tumor-related B symptoms.
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- Known history of Human Immunodeficiency Virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
- Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test result exceeding the detection limit; Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, with Hepatitis B virus DNA quantitative test result exceeding the detection limit (for patients with HBsAg or HBcAb positive status, regardless of HBV-DNA detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial).
- Significant organ dysfunction or uncontrolled comorbidities, such as uncontrolled hypertension, decompensated cirrhosis, uncontrolled diabetes, chronic obstructive pulmonary disease, etc.
- History of severe heart disease.
- Major surgery within 4 weeks prior to enrollment.
- Participation in other clinical trials with drug intervention within 4 weeks prior to enrollment.
- Pregnant or breastfeeding women, or planning to become pregnant during the study.
- Individuals with psychiatric disorders, history of alcohol or drug abuse, or inability to provide informed consent.
- Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong
Qingqing Cai, 02087342823, caiqq@sysucc.org.cn
About this study
Official title: A Multicenter, Phase 2, Randomized Trial of Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A (FL)
This is a multicenter, phase 2, randomized trial to evaluate the efficacy and safety of obinutuzumab with CHOP versus obinutuzumab with bendamustine in treatment-naïve follicular lymphoma (Grade 3A) patients.
- Conditions
- Follicular Lymphoma Grade 3A
- Being tested
- Obinutuzumab, CHOP, Bendamustine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6
CHOPDrug
- Cyclophosphamide: 750 mg/m2 i.v. drip, administered on D1; b) Doxorubicin: 50 mg/m2 i.v. drip (or Epirubicin: 70mg/m2 i.v. drip), administered on D1; c) Vincristine: 1.4 mg/m2 i.v., administered on D1; d) Prednisone: 100mg/d po, administered on D1-5.
BendamustineDrug
90 mg/m2 i.v. drip, administered on D1-2.
| Study group | Role | What they receive |
|---|---|---|
| Obinutuzumab and CHOP Combination Treatment | Active comparator | Obinutuzumab: 1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6.
CHOP: a) Cyclophosphamide: 750 mg/m2 i.v. drip, administered on D1; b) Doxorubicin: 50 mg/m2 i.v. drip (or Epirubicin: 70mg/m2 i.v. drip), administered on D1; c) Vincristine: 1.4 mg/m2 i.v., administered on D1; d) Prednisone: 100mg/d po, administered on D1-5.
Each cycle lasts 21 days, up to 6 cycles are administered. Then add 2 cycles of obinutuzumab monotherapy. Receives: Drug: Obinutuzumab; Drug: CHOP |
| Obinutuzumab and Bendamustine Combination Treatment | Experimental | Obinutuzumab: 1000mg i.v., administered on D1/8/15 of C1, and D1 of C2-6. Bendamustine: 90 mg/m2 i.v. drip, administered on D1-2. Each cycle lasts 28 days, up to 6 cycles are administered. Receives: Drug: Obinutuzumab; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
From study entry to the first documented disease progression or death from any cause.
Measured: Assessed up to 5 years.
Secondary outcomes (5)
Complete Response (CR)
Defined as the proportion of patients who achieve complete remission at the end of induction therapy.
Measured: Up to 6 cycles (up to 24 weeks).
Objective Response Rate (ORR)
The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy.
Measured: Up to 6 cycles (up to 24 weeks).
Event-Free Survival (EFS)
From study entry to the first occurrence of any event, including disease progression, discontinuation of treatment, or death for any reason.
Measured: Assessed up to 5 years.
Overall Survival (OS)
From study entry to death from any cause.
Measured: Assessed up to 5 years.
Progression of Disease within 24 months (POD24)
The occurrence of disease progression or relapse within 24 months from the date of enrollment.
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Lymphoma Grade 3AStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961500
- Sponsor's protocol ID
- B2025-125-01
- Acronym
- PROOF
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 2, Randomized Trial of Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A (FL)
- ClinicalTrials.gov ID
- NCT06961500
- Acronym / sponsor ID
- PROOF / B2025-125-01
- Conditions
- Follicular Lymphoma Grade 3A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 8 May 2025 (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 is a multicenter, phase 2, randomized trial to evaluate the efficacy and safety of obinutuzumab with CHOP versus obinutuzumab with bendamustine in treatment-naïve follicular lymphoma (Grade 3A) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obinutuzumab and CHOP Combination Treatment | Active comparator | Drug: Obinutuzumab, Drug: CHOPObinutuzumab: 1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6. CHOP: a) Cyclophosphamide: 750 mg/m2 i.v. drip, administered on D1; b) Doxorubicin: 50 mg/m2 i.v. drip (or Epirubicin: 70mg/m2 i.v. drip), administered on D1; c) Vincristine: 1.4 mg/m2 i.v., administered on D1; d) Prednisone: 100mg/d po, administered on D1-5. Each cycle lasts 21 days, up to 6 cycles are administered. Then add 2 cycles of obinutuzumab monotherapy. |
| Obinutuzumab and Bendamustine Combination Treatment | Experimental | Drug: Obinutuzumab, Drug: BendamustineObinutuzumab: 1000mg i.v., administered on D1/8/15 of C1, and D1 of C2-6. Bendamustine: 90 mg/m2 i.v. drip, administered on D1-2. Each cycle lasts 28 days, up to 6 cycles are administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed follicular lymphoma Grades 3A, CD20 positive by immunohistochemistry.
- Meets at least one GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria.
- No prior systemic treatment for lymphoma.
- Presence of measurable lesions.
- Age ≥ 18 years, no gender restriction.
Key exclusion criteria (15 listed)
- History of allergy to any component of monoclonal antibodies or investigational drugs.
- Central nervous system involvement.
- History of previous malignant tumors.
- History of active bleeding or bleeding tendencies, or requiring anticoagulant medication.
- Requirement for potent CYP3A4 inhibitors for treatment.
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 |
|---|---|---|
| Obinutuzumab1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6 | Drug | Obinutuzumab and Bendamustine Combination Treatment, Obinutuzumab and CHOP Combination Treatment |
| CHOPa) Cyclophosphamide: 750 mg/m2 i.v. drip, administered on D1; b) Doxorubicin: 50 mg/m2 i.v. drip (or Epirubicin: 70mg/m2 i.v. drip), administered on D1; c) Vincristine: 1.4 mg/m2 i.v., administered on D1; d) Prednisone: 100mg/d po, administered on D1-5. | Drug | Obinutuzumab and CHOP Combination Treatment |
| Bendamustine90 mg/m2 i.v. drip, administered on D1-2. | Drug | Obinutuzumab and Bendamustine Combination Treatment |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Assessed up to 5 years.
From study entry to the first documented disease progression or death from any cause.
5 secondary outcomes
Complete Response (CR)
Time frame: Up to 6 cycles (up to 24 weeks).
Objective Response Rate (ORR)
Time frame: Up to 6 cycles (up to 24 weeks).
Event-Free Survival (EFS)
Time frame: Assessed up to 5 years.
Overall Survival (OS)
Time frame: Assessed up to 5 years.
Progression of Disease within 24 months (POD24)
Time frame: 24 months.
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 8 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obinutuzumab, CHOP and Bendamustine in people with Follicular Lymphoma Grade 3A, run by Sun Yat-sen University 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 8 inclusion and 15 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: opening soon, as of the sponsor's last update on 8 May 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qingqing Cai (0086-020-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Assessed up to 5 years.). 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 8 May 2025.