A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

Lymphoma, Mantle-Cell Clinical Trial

— VEGA  

Official 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

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
• Start date: December 6, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

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	Brzozów
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