Can a Three-Drug combo erase mantle cell lymphoma without chemotherapy?
NCT ID NCT07799220
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
Researchers are testing whether a combination of three drugs, zanubrutinib, obinutuzumab, and sonrotoclax (called BOSon), can effectively treat mantle cell lymphoma in people who have not had prior treatment and are not eligible for a stem cell transplant. The study will enroll about 45 adults aged 65 or older (or younger with health issues that rule out transplant). The goal is to see if this drug combo can achieve a complete response with no detectable minimal residual disease, meaning the cancer is gone at a very sensitive level. The treatment is given in cycles, with zanubrutinib taken as a pill twice daily, obinutuzumab given by IV, and sonrotoclax added later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of three drugs: zanubrutinib (a pill taken twice daily), obinutuzumab (given by IV), and sonrotoclax (a pill started in cycle 2).
- What this could lead to
- If this works, it could offer a powerful, chemotherapy-free option for people with mantle cell lymphoma who cannot undergo a stem cell transplant, potentially leading to deep remissions.
- What could go wrong
- This is a phase II trial with only 45 participants, so results are preliminary. The drug combo may cause side effects like tumor lysis syndrome, and it is not yet known if it will be better than standard treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 45 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 2028
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: * Documentation of disease: Patients must have pathologically confirmed MCL at the treating institution * Evaluable disease, stage II-IV o Patients with non-nodal leukemic MCL may enroll even without FDG PET/CT measurable disease; an end-of-treatment BMBx to confirm response is required in such cases * Age ≥ 65 years at screening * If Age \<65, then required to fulfill one of the following criteria disqualifying for autologous transplant (autoHCT): * Comorbid disease(s) such as CAD, heart failure, pulmonary dysfunction, liver, or kidney dysfunction that precludes autoHCT based on expected increased morbidity * ECOG ≥ 2 (Appendix 1) due to comorbidities * Ejection fraction ≥ 35% and \<45% * Impaired pulmonary function test with DLCO \<50% of expected * Medical conditions that in the opinion of the treating physician in consultation with the MSK PI or Co-PI preclude autoHCT * Not pregnant and not nursing * Required organ function: o Adequate hematologic function, defined as: * Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 or \>= 500 cells/mm3 if cytopenia is related to MCL (bone marrow involvement) * Platelets ≥ 75,000 cells/mm3 or 25,000 if related to MCL * Hemoglobin ≥ 9 g/dL or 8 g/dL if related to MCL Adequate renal function defined as follows: * Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula o Adequate hepatic function defined as follows: * Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN; patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may enroll) * AST and ALT ≤ 2 x institutional ULN Adequate cardiac function defined as follows: * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. * To be eligible for this trial, patients should be class 2B or better (see Appendix 2: New York Heart Association (NYHA) Functional Classification). * No myocardial infarction within 6 months of screening * No unstable angina within 3 months of screening * No history of life-threatening arrhythmias * No CVA within 6 months from C1D1 Patient or healthcare proxy must be able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments * Life expectancy ≥ 6 months * HIV infection: Patients with a history of HIV infection that is well controlled on antiretroviral therapy are eligible if all of the following criteria are met: (1) undetectable HIV viral load by standard clinical assay AND (2) CD4+ T cell count of ≥200 cells/microliter. NOTE: Many HIV treatment regimens have the potential for drug-drug interactions; concomitant antiretroviral therapy should be cleared by a clinical pharmacist and approved by the site PI. * Hepatitis B: Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody \[HBcAb\] and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to take appropriate anti-viral prophylaxis as indicated and undergo monthly DNA testing per SOP * Hepatitis C: Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA Exclusion Criteria: * Active infection requiring parenteral antibiotic(s) * History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention * Patients unable to swallow capsules or those with disease(s) or conditions significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic/active inflammatory bowel disease, or partial or complete bowel obstruction * Patients undergoing major surgery within 4 weeks of the first dose of study drug * Patients with ongoing alcohol or drug addiction or any psychiatric condition(s) which would compromise ability to comply with study procedures * Patients receiving treatment with any moderate or strong CYP3A4 inhibitor or moderate or strong CYP3A4 inducer ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug or requiring ongoing treatment with a moderate or strong CYP3A inhibitor or a moderate or strong CYP3A inducer are ineligible * Concurrent participation in another therapeutic clinical trial * Patients with a prior or concurrent malignancy except for those whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen * Concomitant Medications: Concomitant medications use should only exclude patients from trial participation when clinically relevant known or predicted drug-drug interactions (see Section 5, Appendix 8) or potential overlapping toxicities will impact safety or efficacy. o The following are exclusionary: receiving treatment with any moderate or strong CYP3A4 inhibitor or moderate or strong CYP3A4 inducer ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug or requiring ongoing treatment with a moderate or strong CYP3A inhibitor or a moderate or strong CYP3A inducer. * History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients). * Prior treatment: * Previous systemic therapy is prohibited * Systemic steroids are allowed for urgent disease control, improvement of performance status, or non-cancer indications * Must be \<14 days' duration and ≤ 100 mg/day prednisone equivalent * Steroids must be discontinued prior to C1D1 study treatment * Inhaled, topical, and replacement/stress steroids are permitted
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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
7 sites. 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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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activites)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
East White Plains, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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