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New combo therapy shows promise for Tough-to-Treat lymphoma

NCT ID NCT05564052

Disease control Sponsor: Janssen Research & Development, LLC 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a combination of ibrutinib and rituximab against other standard drug pairs in 36 people with mantle cell lymphoma that had returned or stopped responding to treatment. The main goal was to check safety and side effects, and to keep giving the treatment to those who were benefiting. The study did not aim to cure the disease, but to control it.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

36 people

The number who actually took part.

Started

Dec 2022

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * At least 1 prior treatment regimen for mantle cell lymphoma (MCL) excluding inhibitor of Bruton's tyrosine kinase (BTKi) * Documented disease progression or relapse following the last anti-MCL treatment * At least 1 measurable site of disease on cross-sectional imaging that is greater than or equal to (\>=) 2.0 centimeters (cm) in the longest diameter and measurable in 2 perpendicular dimensions per computed tomography (CT) * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 Exclusion Criteria: * Prior therapy with ibrutinib or other BTK inhibitor * Prior treatment with both lenalidomide and bortezomib. Prior treatment with only 1 of these therapies is allowed * Major surgery within 4 weeks of randomization * Concurrent enrollment in another therapeutic investigational study * Known central nervous system lymphoma * History of stroke or intracranial hemorrhage within 6 months prior to randomization

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Conditions

The condition(s) this trial relates to.

mantle cell lymphoma

As listed by the trial registrant

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

Lymphoma, mantle cell

Contacts and locations

Locations

  • AMRI Hospital, Mukundapur

    Mukundapur, 700099, India

  • American Oncology Institute Cancer Treatment Hospital Hyderabad

    Hyderabad, 500019, India

  • Ankara Bilkent Sehir Hastanesi

    Ankara Sehir Hastanesi, 06800, Turkey (Türkiye)

  • Attikon University General Hospital of Attica

    Athens, 12462, Greece

  • Auxilio Mutuo Cancer Center

    San Juan, 00918, Puerto Rico

  • Bhagwan Mahaveer Cancer Hospital & Research Centre

    Jaipur, 302017, India

  • Casa de Saude Santa Marcelina - Hospital Santa Marcelina

    São Paulo, 08270-120, Brazil

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60 185, Poland

  • Chi Mei Medical Center Liu Ying

    Tainan, 736, Taiwan

  • China Medical University Hospital

    Taichung, 404327, Taiwan

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Complexo Hospitalar de Niteroi

    Niterói, 24020-096, Brazil

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411004, India

  • Ege Universitesi Tip Fakultesi

    Izmir, 35100, Turkey (Türkiye)

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Falu Lasarett Medicinkliniken Falun

    Falun, 791 82, Sweden

  • G.Papanikolaou

    Thessaloniki, 57010, Greece

  • General University Hospital in Prague

    Prague, 128 08, Czechia

  • HCG cancer center

    Jaipur, 302020, India

  • Healthcare Global (HCG) Hospital

    Bangalore, 560027, India

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Reina Sofia

    Córdoba, 14004, Spain

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223, Spain

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031, Spain

  • Hospital Ampang

    Ampang, 68000, Malaysia

  • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

    Ribeirão Preto, 14051-140, Brazil

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88586, Malaysia

  • Hospital Sultanah Aminah

    Johor Bharu, 80100, Malaysia

  • Instituto D Or de Pesquisa e Ensino IDOR

    São Paulo, 04501-000, Brazil

  • Instituto de Ensino e Pesquisa Sao Lucas - IEP HEMOMED

    São Paulo, 01236-030, Brazil

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050 170, Brazil

  • Istanbul University

    Istanbul, 34390, Turkey (Türkiye)

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062-000, Brazil

  • Maharaj Nakorn Chiang Mai hospital Faculty of Medicine

    Chiang Mai, 50200, Thailand

  • Medipol Mega University Hospital

    Istanbul, 34214, Turkey (Türkiye)

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22 250 905, Brazil

  • Ondokuz Mayis University

    Atakum, 55270, Turkey (Türkiye)

  • Ovidius Clinical Hospital OCH

    Ovidiu, 905900, Romania

  • Phramongkutklao Hospital and Medical College

    Bangkok, 10400, Thailand

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10-228, Poland

  • Sakarya Egitim Ve Arastırma Hastanesi Korucuk Kampus

    Sakarya, 54290, Turkey (Türkiye)

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie

    Szczecin, 71252, Poland

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221, Brazil

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia

    Brasília, 70200-730, Brazil

  • Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu

    Wałbrzych, 58 309, Poland

  • Spitalul Clinic Coltea

    Bucharest, 030167, Romania

  • Srinagarind Hospital

    Khon Kaen, 40002, Thailand

  • Subang Jaya Medical Centre

    Subang Jaya, 47500, Malaysia

  • Sunderby Sjukhus

    Luleå, 97180, Sweden

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734, Poland

  • Synergy Superspeciality Hospital

    Rajkot, 360005, India

  • Szpital Specjalistyczny im Jedrzeja Sniadeckiego w Nowym Saczu

    Nowy Sącz, 33 300, Poland

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

    Brzozów, 36 200, Poland

  • Tata Medical Center

    Kolkata, 700156, India

  • Trakya University Medical Faculty

    Edirne, 22030, Turkey (Türkiye)

  • University Hospital of Ioannina

    Ioannina, 45110, Greece

  • University Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

    Lublin, 20-081, Poland

  • Ynova Pesquisa Clinica

    Florianópolis, 88020-210, Brazil

More trials for these conditions

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