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New drug duo aims to slow rare spleen cancer

NCT ID NCT05735834

Disease control Sponsor: International Extranodal Lymphoma Study Group (IELSG) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tests whether adding zanubrutinib to standard rituximab works better than rituximab alone for people with a rare lymphoma of the spleen (SMZL) who haven't had treatment yet. About 122 participants will receive either the combo or rituximab alone for up to two years, with follow-up for three years. The main goal is to see if the combination keeps the cancer from growing longer.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

122 people

The number who actually took part.

Started

May 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ability to understand and willingness to sign a written informed consent in accordance with ICH/GCP regulations before registration and prior to any trial-specific procedures. * Confirmed diagnosis of SMZL, including Matutes immunophenotype score \<3. Evaluation of the following features is desirable: absence of CD103 expression by flow cytometry, absence of Cyclin D1, BCL6, and CD10 expression by immunohistochemistry, and absence of the MYD88 L265P mutation. Patients with prominent splenomegaly and involvement of the splenic hilar and/or extra hilar lymph nodes are eligible * Previously untreated disease. Patients with prior hepatitis C virus (HCV) infection who underwent HCV eradication and have persistent SMZL after 3 months post-eradication can be included. * Treatment needs according to the ESMO guideline criteria * Measurable lesions * Age ≥ 18 years. * European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Absolute neutrophil count (ANC) ≥ 1.0 x 109/L, platelet count ≥ 50 x 109/L, Hb \> 7.5 g/dl. Values below such thresholds are allowed if attributable to the underlying lymphoma. Transfusions are allowed if clinically indicated during screening. * Adequate hepatic and renal function and coagulation parameters * Patient able and willing to swallow trial drugs as whole tablet/capsule Exclusion Criteria: * Previous splenectomy. * Any systemic therapy for SMZL. * Patients with central nervous system (CNS) involvement. * Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer. * Clinically significant cardiovascular disease * History of cerebrovascular accident or intracranial hemorrhage within 6 months before registration and known bleeding disorders (eg, von Willebrand's disease or hemophilia). * History of confirmed progressive multifocal leukoencephalopathy (PML). * Concomitant diseases that require anticoagulant therapy with warfarin or phenprocoumon or other vitamin K antagonists and patients treated with dual anti-platelet therapy. Patients being treated with factor Xa inhibitors (eg, rivaroxaban, apixaban, edoxaban), direct thrombin inhibitors (e. dabigatran) low molecular weight heparin (LMWH), or single anti-platelet agents (eg. aspirin, clopidogrel) can be included but must be properly informed about the potential risk of bleeding. * Malabsorption syndrome or other condition that precludes the enteral route of administration. * Any uncontrolled active systemic infection requiring intravenous antimicrobial treatment. * Known human immunodeficiency virus (HIV) infection. * Active COronaVIrus Disease 19 (COVID-19) infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic. * Active chronic hepatitis C or hepatitis B virus infection * Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune. thrombocytopenia) requiring steroid therapy with \> 20 mg daily of prednisone dose or equivalent. * Known hypersensitivity to trial drugs or any component of the trial drugs. * Concomitant treatment with strong CYP3A inducers or inhibitors * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and/or would make the patient inappropriate for enrolment into this trial. * Pregnancy or breastfeeding. * Concurrent participation in another therapeutic clinical trial.

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Conditions

The condition(s) this trial relates to.

splenic marginal zone lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Splenic marginal zone lymphoma

Contacts and locations

Locations

  • A.O.U. Policlinico G. Rodolico-S. Marco

    Catania, 95123, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • ASST Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

    Palermo, 90146, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100, Italy

  • CHRU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • CHU de Grenoble

    Grenoble, 38043, France

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Clatterbridge Cancer Centre

    Liverpool, L7 8YA, United Kingdom

  • Clinica Universidad de Navarra

    Madrid, Spain

  • Clinica Universidad de Navarra

    Pamplona, Spain

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Guy's Hospital - Guy's and St. Thomas' NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • Hospedal Clinic de Barcelona

    Barcelona, Spain

  • Hospital 12 De Octubre

    Madrid, Spain

  • Hospital Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Hospital Clinico De Valencia

    Valencia, Spain

  • Hospital De Donostia

    San Sebastián, Spain

  • Hospital De Salamanca

    Salamanca, Spain

  • Hospital Gregorio Marañón

    Madrid, Spain

  • Hospital Ramon y Cajal

    Madrid, Spain

  • Hospital Universitario Cruces

    Bilbao, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain

  • Hospital Vall d'Hebron

    Barcelona, Spain

  • Hospital Virgen Arrixaca

    El Palmar, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Hôpital Lyon-Sud

    Pierre-Bénite, 69495, France

  • Hôpital Saint Louis

    Paris, 75475, France

  • INSELSPITAL, Bern University Hospital

    Bern, 3010, Switzerland

  • IRCCS AOU di Bologna

    Bologna, 40138, Italy

  • IRCCS IRST Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

    Meldola, 47014, Italy

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, 70124, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • IRCCS Policlinico San Matteo

    Pavia, Italy

  • Institut Bergonié

    Bordeaux, 33076, France

  • Istitut Català d'Oncologia, Hospital Duran i Reynals

    Barcelona, Spain

  • Karolinska University Hospital

    Stockholm, Sweden

  • Medical University of Vienna

    Vienna, Austria

  • Oncology Institute of Southern Switzerland

    Bellinzona, 6500, Switzerland

  • Oslo University Hospital

    Oslo, Norway

  • Ospedale Santa Maria delle Croci

    Ravenna, 48121, Italy

  • Ospedale di Circolo e Fondazione Macchi - ASST dei Sette Laghi

    Varese, 21100, Italy

  • Policlinico Santa Maria alle Scotte

    Siena, 53100, Italy

  • The Christie

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT, United Kingdom

  • USL-IRCCS of Reggio Emilia, Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123, Italy

  • University College London Hospitals

    London, NW1 2PG, United Kingdom

  • University Hospital of Wales

    Cardiff, CF14 4XW, United Kingdom

  • University Hospitals Dorset

    Bournemouth, BH7 7DW, United Kingdom

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Other studies related to the condition(s) this trial covers.