Lymphoma, Mantle-Cell Clinical Trial
— VEGAOfficial title:
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
Verified date | June 2024 |
Source | Janssen Research & Development, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC | Pharmacyclics LLC. |
Brazil, Czechia, Greece, India, Malaysia, Poland, Puerto Rico, Romania, Spain, Sweden, Taiwan, Thailand, Turkey,
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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