Clinical trial NCT05564052: A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Mantle-Cell
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pharmacyclics LLC.
First posted: 2022-10-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and B
timeFrame: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Monotherapy Arm
timeFrame: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
measure: Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Arms A1, A2, A3 and B
timeFrame: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)
measure: Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Monotherapy Arm
timeFrame: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
measure: Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Arms A1, A2, A3 and B
timeFrame: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months)
measure: Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Monotherapy Arm
timeFrame: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 6 months)
measure: Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B
timeFrame: From start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months)
measure: Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm
timeFrame: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug (up to 6 months)
measure: Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B
timeFrame: From start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months)
measure: Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm
timeFrame: From start of monotherapy (post protocol amendment 1, dated 08 June 2023) up to 30 days after last dose of study drug (up to 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Brasilia
country: Brazil
facility: Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
city: Florianopolis
country: Brazil
facility: Ynova Pesquisa Clinica
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Niteroi
country: Brazil
facility: Complexo Hospitalar de Niteroi
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Ribeirao Preto
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP HEMOMED
city: Sao Paulo
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Sao Paulo
country: Brazil
facility: Casa de Saude Santa Marcelina - Hospital Santa Marcelina
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: General University Hospital in Prague
city: Athens
country: Greece
facility: Attikon University General Hospital of Attica
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Thessaloniki
country: Greece
facility: G.Papanikolaou
city: Bangalore
country: India
facility: Healthcare Global (HCG) Hospital
city: Hyderabad
country: India
facility: American Oncology Institute Cancer Treatment Hospital Hyderabad
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital & Research Centre
city: Jaipur
country: India
facility: HCG cancer center
city: Kolkata
country: India
facility: Tata Medical Center
city: Mukundapur
country: India
facility: AMRI Hospital, Mukundapur
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
city: Rajkot
country: India
facility: Synergy Superspeciality Hospital
city: Ampang
country: Malaysia
facility: Hospital Ampang
city: Johor Bharu
country: Malaysia
facility: Hospital Sultanah Aminah
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Subang Jaya
country: Malaysia
facility: Subang Jaya Medical Centre
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
city: Nowy Sacz
country: Poland
facility: Szpital Specjalistyczny im Jedrzeja Sniadeckiego w Nowym Saczu
city: Olsztyn
country: Poland
facility: SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
city: Walbrzych
country: Poland
facility: Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: San Juan
country: Puerto Rico
facility: Auxilio Mutuo Cancer Center
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea
city: Ovidiu
country: Romania
facility: Ovidius Clinical Hospital OCH
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Madrid
country: Spain
facility: Hosp. Univ. Infanta Leonor
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Pozuelo de Alarcon
country: Spain
facility: Hosp. Quiron Madrid Pozuelo
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Falun
country: Sweden
facility: Falu Lasarett Medicinkliniken Falun
city: Luleå
country: Sweden
facility: Sunderby Sjukhus
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center Liu Ying
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital and Medical College
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: ChiangMai
country: Thailand
facility: Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Ankara Sehir Hastanesi
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Atakum
country: Turkey
facility: Ondokuz Mayis University
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Medipol Mega University Hospital
city: Istanbul
country: Turkey
facility: Istanbul University
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Sakarya
country: Turkey
facility: Sakarya Egitim Ve Arastırma Hastanesi Korucuk Kampus
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: