NCT07550855Not yet recruitingPhase 2
Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma
A Phase II, Multicenter, Single-Arm Study of Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma (FLOURISH)
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 19 Apr 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Mar 2028
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Follicular lymphoma
- NCT number
- NCT07550855
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 52
- From 1 Sept 2026 to the primary completion date, 30 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of allergy to the investigational drug, similar drugs, or excipients.
- Active systemic infection requiring intravenous antibiotic therapy or hospitalization (occurring within 4 weeks prior to screening).
- 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).
- 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.
Other illness
- Known active central nervous system lymphoma or leptomeningeal disease.
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
- Confirmed progressive multifocal leukoencephalopathy (PML), positive for human T-lymphotropic virus type 1 (HTLV-1), or suspected active/latent tuberculosis.
- Autoimmune anemia and/or thrombocytopenia that does not respond adequately to corticosteroids or other standard treatments.
Lab values
- Receipt of medications known to prolong the QT/QTc interval.
Age
- 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).
Other
- Evidence of follicular lymphoma with transformation to diffuse large B-cell lymphoma.
- Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
- Patients with significant dysfunction of vital organs.
- Unwillingness or inability to complete all assessments and procedures required by the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Universitiy Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.