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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05564052
Other study ID # CR109252
Secondary ID 2022-000364-2154
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 6, 2022
Est. completion date September 30, 2024

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.


Description:

Mantle cell lymphoma (MCL) is an uncommon and incurable clinicopathologic subtype of B-cell non-Hodgkin Lymphoma (NHL). Ibrutinib is a first-in-class potent, orally administered, covalently-binding small molecule inhibitor of Bruton's tyrosine kinase (BTKi) for the treatment of B-cell malignancies and chronic graft-versus-host disease. The primary hypothesis of the study is to provide continued access to treatment for participants who continue to benefit from treatment. The study will include a screening phase (up to 30 days prior to randomization), a treatment phase (from randomization until study treatment discontinuation). safety assessments include adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, vital signs, electrocardiogram (ECG), physical examination. The Phase 2 exploratory objectives and endpoints of characterization of pharmacokinetic and pharmacodynamic of ibrutinib may continue to be evaluated using blood samples already collected. The total duration of the study will be up to 2 years 1 month.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 36
Est. completion date September 30, 2024
Est. primary completion date December 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ibrutinib
Ibrutinib capsules will be administered orally.
Lenalidomide
Lenalidomide capsules will be administered orally.
Rituximab
Rituximab will be administered IV.
Bortezomib
Bortezomib will be administered either intravenously or subcutaneously.

Locations

Country Name City State
Brazil Santa Casa de Misericordia de Belo Horizonte Belo Horizonte
Brazil Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia Brasilia
Brazil Ynova Pesquisa Clinica Florianopolis
Brazil Liga Norte Riograndense Contra O Cancer Natal
Brazil Complexo Hospitalar de Niteroi Niteroi
Brazil Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre
Brazil Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP Ribeirao Preto
Brazil Oncoclinicas Rio de Janeiro S A Rio de Janeiro
Brazil Casa de Saude Santa Marcelina - Hospital Santa Marcelina Sao Paulo
Brazil Instituto D Or de Pesquisa e Ensino (IDOR) Sao Paulo
Brazil Instituto de Ensino e Pesquisa Sao Lucas - IEP HEMOMED Sao Paulo
Czechia Fakultni nemocnice Ostrava Ostrava
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10
Czechia General University Hospital in Prague Praha 2
Greece Attikon University General Hospital of Attica Athens
Greece University Hospital of Ioannina Ioannina
Greece G.Papanikolaou Thessaloniki
India Healthcare Global (HCG) Hospital Bangalore
India American Oncology Institute Cancer Treatment Hospital Hyderabad Hyderabad
India Bhagwan Mahaveer Cancer Hospital & Research Centre Jaipur
India HCG cancer center Jaipur
India Tata Medical Center Kolkata
India AMRI Hospital, Mukundapur Mukundapur
India Deenanath Mangeshkar Hospital and Research Centre Pune
India Synergy Superspeciality Hospital Rajkot
Malaysia Hospital Ampang Ampang
Malaysia Hospital Sultanah Aminah Johor Bharu
Malaysia Hospital Queen Elizabeth Kota Kinabalu
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Subang Jaya Medical Centre Subang Jaya
Poland Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza Brzozow
Poland Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Kielce
Poland Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Lublin
Poland Szpital Specjalistyczny im Jedrzeja Sniadeckiego w Nowym Saczu Nowy Sacz
Poland SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie Olsztyn
Poland Centrum Medyczne Pratia Poznan Skorzewo
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie Szczecin
Poland Specjalistyczny Szpital im. dra Alfreda Sokolowskiego w Walbrzychu Walbrzych
Poland Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
Puerto Rico Auxilio Mutuo Cancer Center San Juan
Romania Spitalul Clinic Coltea Bucuresti
Romania Ovidius Clinical Hospital OCH Ovidiu
Spain Hosp Reina Sofia Cordoba
Spain Hosp. Univ. Infanta Leonor Madrid
Spain Clinica Univ. de Navarra Pamplona
Spain Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcon
Spain Hosp Clinico Univ de Salamanca Salamanca
Sweden Falu Lasarett Medicinkliniken Falun Falun
Sweden Sunderby Sjukhus Luleå
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan Chi Mei Medical Center Liu Ying Tainan
Taiwan National Taiwan University Hospital Taipei
Thailand King Chulalongkorn Memorial Hospital Bangkok
Thailand Phramongkutklao Hospital and Medical College Bangkok
Thailand Ramathibodi Hospital Bangkok
Thailand Siriraj Hospital Bangkok
Thailand Maharaj Nakorn Chiang Mai hospital Faculty of Medicine ChiangMai
Thailand Srinagarind Hospital Khon Kaen
Turkey Ankara Bilkent Sehir Hastanesi Ankara Sehir Hastanesi
Turkey Ondokuz Mayis Universitesi Tip Fakultesi Atakum
Turkey Trakya University Medical Faculty Edirne
Turkey Istanbul University Istanbul
Turkey Medipol Mega University Hospital Istanbul
Turkey Ege Universitesi Tip Fakultesi Izmir
Turkey Sakarya Egitim Ve Arastirma Hastanesi Korucuk Kampus Sakarya

Sponsors (2)

Lead Sponsor Collaborator
Janssen Research & Development, LLC Pharmacyclics LLC.

Countries where clinical trial is conducted

Brazil,  Czechia,  Greece,  India,  Malaysia,  Poland,  Puerto Rico,  Romania,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events (AEs) that Resulted in Discontinuation of Treatment, Severe AE, or Serious Adverse Events (SAEs) An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE defined as results in death, is life-threatening (the participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is Medically Important. Up to 6 months
Primary Number of Participants with Abnormalities in Clinical Laboratory Parameters Number of participants with abnormalities in clinical laboratory parameters (hematology and serum chemistry) will be reported. Up to 6 months
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