Chemo-free triplet aims to outsmart incurable lymphoma
NCT ID NCT07550855
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a chemotherapy-free combination of three drugs (sonrotoclax, zanubrutinib, and rituximab) in 52 adults with previously untreated follicular lymphoma. The goal is to see if this approach can produce deeper and longer-lasting remissions while being easier to tolerate than standard chemo. Participants must have advanced-stage disease and meet certain health criteria.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Willing to participate in the clinical study and signed informed consent. 2. Age ≥18 years, no gender restrictions. 3. Pathologically diagnosed with follicular lymphoma (Grade 1, 2, or 3a) and previously untreated. 4. Has at least one measurable or assessable lesion. 5. Ann-Arbor stage III or IV, or stage II with bulky disease. 6. Meets at least one GELF criterion. 7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. 8. Adequate major organ function. Exclusion Criteria: 1. Known active central nervous system lymphoma or leptomeningeal disease. 2. Evidence of follicular lymphoma with transformation to diffuse large B-cell lymphoma. 3. 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). 4. History of allergy to the investigational drug, similar drugs, or excipients. 5. Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS). 6. Active systemic infection requiring intravenous antibiotic therapy or hospitalization (occurring within 4 weeks prior to screening). 7. Confirmed progressive multifocal leukoencephalopathy (PML), positive for human T-lymphotropic virus type 1 (HTLV-1), or suspected active/latent tuberculosis. 8. Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception. 9. Patients with significant dysfunction of vital organs. 10. 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. 11. 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. 12. Receipt of concurrent therapy for the study disease outside of this clinical study (including the screening period). 13. Autoimmune anemia and/or thrombocytopenia that does not respond adequately to corticosteroids or other standard treatments. 14. Receipt of medications known to prolong the QT/QTc interval. 15. Vaccination with a live vaccine within ≤35 days prior to the first dose of study drug. 16. Major surgery within 4 weeks prior to the first dose of study drug. 17. Unwillingness or inability to complete all assessments and procedures required by the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen Universitiy Cancer Center
Guangzhou, Guangdong, China
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Other studies related to the condition(s) this trial covers.
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