NCT05564052CompletedPhase 2
A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
A Randomized, Controlled, Open-label, Multicenter, Inferentially Seamless Phase 2/3 Study of Ibrutinib in Combination With Rituximab Versus Physician's Choice of Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab in Participants With Relapsed or Refractory Mantle Cell Lymphoma
Source: ClinicalTrials.gov · Last updated 7 Oct 2025
Brief summary (registry, in English)
The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 30 Sept 2022
- Start date
- 6 Dec 2022
- Primary completion date
- 6 Dec 2023
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Mantle cell lymphoma
- NCT number
- NCT05564052
- EU CT number
- 2023-503618-64-00
- EudraCT number
- 2022-000364-21
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 36
- From 6 Dec 2022 to the primary completion date, 6 Dec 2023
- 55 sites in 13 countries
- 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
- 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
- History of stroke or intracranial hemorrhage within 6 months prior to randomization
Other
- Known central nervous system lymphoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (55)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Santa Casa de Misericordia de Belo Horizonte Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Ynova Pesquisa Clinica Coordinator of this site? Confirm its status | Florianópolis | Brazil | Unknown status |
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| Complexo Hospitalar de Niteroi Coordinator of this site? Confirm its status | Niterói | Brazil | Unknown status |
| Irmandade Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
| Oncoclinicas Rio de Janeiro S A Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto de Ensino e Pesquisa Sao Lucas - IEP HEMOMED Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Casa de Saude Santa Marcelina - Hospital Santa Marcelina Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto D'Or de Pesquisa e Ensino (IDOR) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Completed |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Completed |
| Attikon University General Hospital of Attica Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| University Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Unknown status |
| G.Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Healthcare Global (HCG) Hospital Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| American Oncology Institute Cancer Treatment Hospital Hyderabad Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| HCG cancer center Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| Bhagwan Mahaveer Cancer Hospital & Research Centre Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| Tata Medical Center Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| AMRI Hospital, Mukundapur Coordinator of this site? Confirm its status | Mukundapur | India | Unknown status |
| Deenanath Mangeshkar Hospital and Research Centre Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Synergy Superspeciality Hospital Coordinator of this site? Confirm its status | Rajkot | India | Unknown status |
| Hospital Ampang Coordinator of this site? Confirm its status | Ampang | Malaysia | Unknown status |
| Hospital Sultanah Aminah Coordinator of this site? Confirm its status | Johor Bharu | Malaysia | Unknown status |
| Hospital Queen Elizabeth Coordinator of this site? Confirm its status | Kota Kinabalu | Malaysia | Unknown status |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Subang Jaya Medical Centre Coordinator of this site? Confirm its status | Subang Jaya | Malaysia | Unknown status |
| Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Coordinator of this site? Confirm its status | Brzozów | Poland | Completed |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Completed |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Auxilio Mutuo Cancer Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Spitalul Clinic Colțea Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Ovidius Clinical Hospital OCH Coordinator of this site? Confirm its status | Ovidiu | Romania | Unknown status |
| Falu Lasarett Medicinkliniken Falun Coordinator of this site? Confirm its status | Falun | Sweden | Unknown status |
| Sunderby Sjukhus Coordinator of this site? Confirm its status | Luleå | Sweden | Unknown status |
| Ramathibodi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Phramongkutklao Hospital and Medical College Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| King Chulalongkorn Memorial Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai hospital Faculty of Medicine Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Srinagarind Hospital Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Chi Mei Medical Center Liu Ying Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Ankara Bilkent Sehir Hastanesi Coordinator of this site? Confirm its status | Ankara Sehir Hastanesi | Turkey (Türkiye) | Unknown status |
| Ondokuz Mayis University Coordinator of this site? Confirm its status | Atakum | Turkey (Türkiye) | Unknown status |
| Trakya University Medical Faculty Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Istanbul University Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Medipol Mega University Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Ege Universitesi Tip Fakultesi Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Sakarya Egitim Ve Arastırma Hastanesi Korucuk Kampus Coordinator of this site? Confirm its status | Sakarya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.