Follicular Lymphoma (FL)Phase 2FLOURISHNCT07550855
Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma
A Phase 2 study testing Sotoclax in combination with zanubrutinib and rituximab regimen in people with Follicular Lymphoma (FL), run by Sun Yat-sen University at 1 site in China.
Trial summary
Follicular lymphoma (FL) remains an incurable indolent B-cell lymphoma for many patients, and although rituximab-based chemoimmunotherapy can achieve high initial response rates, a substantial proportion of patients experience early progression, including POD24, which is associated with poor long-term outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma (FL)
- What is being tested?
- Sotoclax in combination with zanubrutinib and rituximab regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Sep 2029
- 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
- Willing to participate in the clinical study and signed informed consent.
- Age ≥18 years, no gender restrictions.
- Pathologically diagnosed with follicular lymphoma (Grade 1, 2, or 3a) and previously untreated.
- Has at least one measurable or assessable lesion.
- Ann-Arbor stage III or IV, or stage II with bulky disease.
- Meets at least one GELF criterion.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
- Adequate major organ function.
Who cannot join
- Known active central nervous system lymphoma or leptomeningeal disease.
- Evidence of follicular lymphoma with transformation to diffuse large B-cell lymphoma.
- Prior history of other malignancies other than follicular lymphoma (except for those with disease-free survival ≥5 years and assessed by the investigator as having low risk of recurrence).
- History of allergy to the investigational drug, similar drugs, or excipients.
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
- Active systemic infection requiring intravenous antibiotic therapy or hospitalization (occurring within 4 weeks prior to screening).
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- Confirmed progressive multifocal leukoencephalopathy (PML), positive for human T-lymphotropic virus type 1 (HTLV-1), or suspected active/latent tuberculosis.
- Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
- Patients with significant dysfunction of vital organs.
- Receipt of any moderate or strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days (or 5 half-lives, whichever is longer) prior to the first dose of sotoclax.
- Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 7 days prior to the first dose of zanubrutinib, or requirement for continuous use of strong CYP3A inhibitors/inducers.
- Receipt of concurrent therapy for the study disease outside of this clinical study (including the screening period).
- Autoimmune anemia and/or thrombocytopenia that does not respond adequately to corticosteroids or other standard treatments.
- Receipt of medications known to prolong the QT/QTc interval.
- Vaccination with a live vaccine within ≤35 days prior to the first dose of study drug.
- Major surgery within 4 weeks prior to the first dose of study drug.
- Unwillingness or inability to complete all assessments and procedures required by 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.
China1 site
Sun Yat-sen Universitiy Cancer Center
Guangzhou, Guangdong
Qingqing Cai, (020)87342823, caiqq@sysucc.org.cn
About this study
Official title: A Phase II, Multicenter, Single-Arm Study of Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma (FLOURISH)
Follicular lymphoma (FL) remains an incurable indolent B-cell lymphoma for many patients, and although rituximab-based chemoimmunotherapy can achieve high initial response rates, a substantial proportion of patients experience early progression, including POD24, which is associated with poor long-term outcomes. This underscores the need for more effective and better-tolerated frontline treatment strategies, particularly chemotherapy-free approaches. The present study is based on a strong biologic rationale that simultaneously targets two key pathogenic mechanisms in FL: aberrant B-cell receptor signaling and impaired apoptosis driven by BCL2 overexpression. Zanubrutinib, a next-generation BTK inhibitor, has shown clinical activity with a favorable safety profile in FL, while sonrotoclax, a potent and highly selective next-generation BCL2 inhibitor, has demonstrated promising preclinical and early clinical activity. In combination with rituximab, this chemotherapy-free triplet regimen may produce deeper and more durable remissions while maintaining manageable toxicity, and therefore has the potential to expand frontline treatment options and improve outcomes for patients with previously untreated FL.
- Conditions
- Follicular Lymphoma (FL)
- Being tested
- Sotoclax in combination with zanubrutinib and rituximab regimen
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sotoclax in combination with zanubrutinib and rituximab regimenDrug
Zanubrutinib oral administration, Sotoclax oral administration, Rituximab intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Sotoclax in combination with zanubrutinib and rituximab regimen Receives: Drug: Sotoclax in combination with zanubrutinib and rituximab regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate
Complete response rate
Measured: Up to 6 months
Secondary outcomes (4)
ORR
Overall response rate
Measured: Up to 6 months
DoR
Duration of response
Measured: Up to 3 years
PFS
Progression free survival
Measured: Up to 3 years
OS
Overall survival
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Lymphoma (FL)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 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
- Investigators
- Qingqing Cai, Principal investigator, Sun Yat-sen Universitiy Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550855
- Sponsor's protocol ID
- B2026-169-01
- Acronym
- FLOURISH
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Single-Arm Study of Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma (FLOURISH)
- ClinicalTrials.gov ID
- NCT07550855
- Acronym / sponsor ID
- FLOURISH / B2026-169-01
- Conditions
- Follicular Lymphoma (FL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 24 Apr 2026 (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.
Follicular lymphoma (FL) remains an incurable indolent B-cell lymphoma for many patients, and although rituximab-based chemoimmunotherapy can achieve high initial response rates, a substantial proportion of patients experience early progression, including POD24, which is associated with poor long-term outcomes. This underscores the need for more effective and better-tolerated frontline treatment strategies, particularly chemotherapy-free approaches. The present study is based on a strong biologic rationale that simultaneously targets two key pathogenic mechanisms in FL: aberrant B-cell receptor signaling and impaired apoptosis driven by BCL2 overexpression. Zanubrutinib, a next-generation BTK inhibitor, has shown clinical activity with a favorable safety profile in FL, while sonrotoclax, a potent and highly selective next-generation BCL2 inhibitor, has demonstrated promising preclinical and early clinical activity. In combination with rituximab, this chemotherapy-free triplet regimen may produce deeper and more durable remissions while maintaining manageable toxicity, and therefore has the potential to expand frontline treatment options and improve outcomes for patients with previously untreated FL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Sotoclax in combination with zanubrutinib and rituximab regimenSotoclax in combination with zanubrutinib and rituximab regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing to participate in the clinical study and signed informed consent.
- Age ≥18 years, no gender restrictions.
- Pathologically diagnosed with follicular lymphoma (Grade 1, 2, or 3a) and previously untreated.
- Has at least one measurable or assessable lesion.
- Ann-Arbor stage III or IV, or stage II with bulky disease.
Key exclusion criteria (17 listed)
- Known active central nervous system lymphoma or leptomeningeal disease.
- Evidence of follicular lymphoma with transformation to diffuse large B-cell lymphoma.
- Prior history of other malignancies other than follicular lymphoma (except for those with disease-free survival ≥5 years and assessed by the investigator as having low risk of recurrence).
- History of allergy to the investigational drug, similar drugs, or excipients.
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
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 |
|---|---|---|
| Sotoclax in combination with zanubrutinib and rituximab regimenZanubrutinib oral administration, Sotoclax oral administration, Rituximab intravenous injection. | Drug | Experimental Group |
Primary outcome
CR rate
Time frame: Up to 6 months
Complete response rate
4 secondary outcomes
ORR
Time frame: Up to 6 months
DoR
Time frame: Up to 3 years
PFS
Time frame: Up to 3 years
OS
Time frame: Up to 3 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 24 Apr 2026.
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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.
Qingqing Cai principal investigator
Sun Yat-sen Universitiy Cancer Center
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 Sotoclax in combination with zanubrutinib and rituximab regimen in people with Follicular Lymphoma (FL), 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 17 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 24 Apr 2026. 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 ((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?
CR rate (time frame: Up to 6 months). 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 24 Apr 2026.