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| ID | Type | Description | Link |
|---|---|---|---|
| 54179060MCL3004 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-000364-21 | EudraCT Number | ||
| 2023-503618-64-00 | Registry Identifier | EUCT number |
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| Name | Class |
|---|---|
| Pharmacyclics LLC. | INDUSTRY |
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The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: Treatment Arm A1 (Rituximab plus Ibrutinib) | Experimental | Participants will receive rituximab 375 milligrams per meter square (mg/m^2) intravenously (IV) on Day 1 of Cycles 1 to 6 with ibrutinib 560 milligrams (mg) orally, once daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days). |
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| Phase 2: Treatment Arm A2 (Rituximab plus Ibrutinib) | Experimental | Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 with ibrutinib 420 mg orally, once daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days). |
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| Phase 2: Treatment Arm A3 (Rituximab plus Ibrutinib) | Experimental | Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 with ibrutinib 140 mg orally, twice daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days). |
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| Phase 2: Treatment Arm B (Rituximab plus Lenalidomide or Bortezomib) | Experimental | Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 (each cycle length is 21 or 28 days) with physician's choice of either lenalidomide 20 mg orally, once daily from Day 1 through Day 21 of 28-day cycle or bortezomib 1.3 mg/m^2 IV or subcutaneously (SC) on Days 1, 4, 8 and 11 of a 21-day cycle until disease progression or unacceptable toxicity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib capsules will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and B | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure. | 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) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Monotherapy Arm | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. All TEAEs included serious and non-serious events were reported in this outcome measure. | 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) |
| 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 | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0 as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences and Grade 5- Death related to AE. Number of participants with grade 3 or higher TEAEs (including serious and non-serious events) were reported in this outcome measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte | 30150-221 | Brazil | |||
| Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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The study was planned to be conducted in 2 parts: Phase 2 and Phase 3. However, due to early termination of enrollment, no participants were enrolled on the Phase 3 part of the study. Hence, the results were only presented for Phase 2 part. Participants with relapsed or refractory mantle cell lymphoma were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2023 | Dec 5, 2024 |
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| Lenalidomide | Drug | Lenalidomide capsules will be administered orally. |
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| Rituximab | Drug | Rituximab will be administered IV. |
|
| Bortezomib | Drug | Bortezomib will be administered either intravenously or subcutaneously. |
|
| 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) |
| 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 | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0 as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences and Grade 5- Death related to AE. Number of participants with grade 3 or higher TEAEs (including serious and non-serious events) were reported in this outcome measure. | 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) |
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Arms A1, A2, A3 and B | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TESAEs was defined as SAEs occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. | 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) |
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Monotherapy Arm | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TESAEs was defined as SAEs occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. | 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) |
| Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B | Number of participants with clinical abnormalities in hematology laboratory parameters were reported. Hematology parameters included: Activated partial thromboplastin time (aPTT), hemoglobin, neutrophil count, white blood cell (WBC) count, lymphocyte count, platelet count and prothrombin international normalized ratio (INR). Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported. | From start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months) |
| Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm | Number of participants with clinical abnormalities in hematology laboratory parameters were reported. Hematology parameters included: Activated partial thromboplastin time (aPTT), hemoglobin, neutrophil count, white blood cell (WBC) count, lymphocyte count, platelet count and prothrombin international normalized ratio (INR). Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported. | 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) |
| Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B | Number of participants with clinical abnormalities in chemistry laboratory parameters were reported. Chemistry parameters included: sodium, aspartate aminotransferase (AST), potassium, alanine aminotransferase (ALT), creatinine, total bilirubin (BL), alkaline phosphatase, albumin, and calcium. Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported. | From start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months) |
| Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm | Number of participants with clinical abnormalities in chemistry laboratory parameters were reported. Chemistry parameters included: sodium, aspartate aminotransferase (AST), potassium, alanine aminotransferase (ALT), creatinine, total bilirubin, alkaline phosphatase, albumin, and calcium. Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported. | 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) |
| BrasÃlia |
| 70200-730 |
| Brazil |
| Ynova Pesquisa Clinica | Florianópolis | 88020-210 | Brazil |
| Liga Norte Riograndense Contra O Cancer | Natal | 59062-000 | Brazil |
| Complexo Hospitalar de Niteroi | Niterói | 24020-096 | Brazil |
| Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | 90050 170 | Brazil |
| Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP | Ribeirão Preto | 14051-140 | Brazil |
| Oncoclinicas Rio de Janeiro S A | Rio de Janeiro | 22 250 905 | Brazil |
| Instituto de Ensino e Pesquisa Sao Lucas - IEP HEMOMED | São Paulo | 01236-030 | Brazil |
| Instituto D Or de Pesquisa e Ensino IDOR | São Paulo | 04501-000 | Brazil |
| Casa de Saude Santa Marcelina - Hospital Santa Marcelina | São Paulo | 08270-120 | Brazil |
| Fakultni Nemocnice Ostrava | Ostrava | 708 52 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| General University Hospital in Prague | Prague | 128 08 | Czechia |
| Attikon University General Hospital of Attica | Athens | 12462 | Greece |
| University Hospital of Ioannina | Ioannina | 45110 | Greece |
| G.Papanikolaou | Thessaloniki | 57010 | Greece |
| Healthcare Global (HCG) Hospital | Bangalore | 560027 | India |
| American Oncology Institute Cancer Treatment Hospital Hyderabad | Hyderabad | 500019 | India |
| Bhagwan Mahaveer Cancer Hospital & Research Centre | Jaipur | 302017 | India |
| HCG cancer center | Jaipur | 302020 | India |
| Tata Medical Center | Kolkata | 700156 | India |
| AMRI Hospital, Mukundapur | Mukundapur | 700099 | India |
| Deenanath Mangeshkar Hospital and Research Centre | Pune | 411004 | India |
| Synergy Superspeciality Hospital | Rajkot | 360005 | India |
| Hospital Ampang | Ampang | 68000 | Malaysia |
| Hospital Sultanah Aminah | Johor Bharu | 80100 | Malaysia |
| Hospital Queen Elizabeth | Kota Kinabalu | 88586 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Subang Jaya Medical Centre | Subang Jaya | 47500 | Malaysia |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza | Brzozów | 36 200 | Poland |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach | Kielce | 25 734 | Poland |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie | Lublin | 20-081 | Poland |
| Szpital Specjalistyczny im Jedrzeja Sniadeckiego w Nowym Saczu | Nowy SÄ…cz | 33 300 | Poland |
| SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie | Olsztyn | 10-228 | Poland |
| Centrum Medyczne Pratia Poznan | Skorzewo | 60 185 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie | Szczecin | 71252 | Poland |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu | Wałbrzych | 58 309 | Poland |
| Auxilio Mutuo Cancer Center | San Juan | 00918 | Puerto Rico |
| Spitalul Clinic Coltea | Bucharest | 030167 | Romania |
| Ovidius Clinical Hospital OCH | Ovidiu | 905900 | Romania |
| Hosp Reina Sofia | Córdoba | 14004 | Spain |
| Hosp. Univ. Infanta Leonor | Madrid | 28031 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp. Quiron Madrid Pozuelo | Pozuelo de Alarcón | 28223 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Falu Lasarett Medicinkliniken Falun | Falun | 791 82 | Sweden |
| Sunderby Sjukhus | Luleå | 97180 | Sweden |
| Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| China Medical University Hospital | Taichung | 404327 | Taiwan |
| Chi Mei Medical Center Liu Ying | Tainan | 736 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital and Medical College | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai hospital Faculty of Medicine | Chiang Mai | 50200 | Thailand |
| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Ankara Bilkent Sehir Hastanesi | Ankara Sehir Hastanesi | 06800 | Turkey (Türkiye) |
| Ondokuz Mayis University | Atakum | 55270 | Turkey (Türkiye) |
| Trakya University Medical Faculty | Edirne | 22030 | Turkey (Türkiye) |
| Medipol Mega University Hospital | Istanbul | 34214 | Turkey (Türkiye) |
| Istanbul University | Istanbul | 34390 | Turkey (Türkiye) |
| Ege Universitesi Tip Fakultesi | Izmir | 35100 | Turkey (Türkiye) |
| Sakarya Egitim Ve Arastırma Hastanesi Korucuk Kampus | Sakarya | 54290 | Turkey (Türkiye) |
| FG001 | Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| FG002 | Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| FG003 | Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2 | Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance [CrCl] was 30 to less than [<] 60 milliliters per minute [mL/min]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| Participants Who Switched to Ibrutinib Monotherapy |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| BG001 | Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| BG002 | Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| BG003 | Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2 | Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance [CrCl] was 30 to less than [<] 60 milliliters per minute [mL/min]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and B | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. All TEAEs including serious and non-serious events were reported in this outcome measure. | Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Monotherapy Arm | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. All TEAEs included serious and non-serious events were reported in this outcome measure. | Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy. | Posted | Count of Participants | Participants | 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) |
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| Primary | 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 | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0 as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences and Grade 5- Death related to AE. Number of participants with grade 3 or higher TEAEs (including serious and non-serious events) were reported in this outcome measure. | Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. | Posted | Count of Participants | Participants | 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) |
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| Primary | 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 | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs was defined as any new or worsening AE occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. TEAEs were graded according to NCI-CTCAE v5.0 as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe or medically significant but not immediately life-threatening; Grade 4- Life-threatening consequences and Grade 5- Death related to AE. Number of participants with grade 3 or higher TEAEs (including serious and non-serious events) were reported in this outcome measure. | Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Arms A1, A2, A3 and B | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TESAEs was defined as SAEs occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. | Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Monotherapy Arm | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TESAEs was defined as SAEs occurring at or after first dose of study treatment up to 30 days after last dose or prior to start of subsequent anticancer therapy, whichever occurred first. | Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B | Number of participants with clinical abnormalities in hematology laboratory parameters were reported. Hematology parameters included: Activated partial thromboplastin time (aPTT), hemoglobin, neutrophil count, white blood cell (WBC) count, lymphocyte count, platelet count and prothrombin international normalized ratio (INR). Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported. | Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Here, 'n' (number analyzed) signifies the participants analyzed for each specified parameter and n=0 signifies that there was no evaluable participant for specified parameter. | Posted | Count of Participants | Participants | From start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm | Number of participants with clinical abnormalities in hematology laboratory parameters were reported. Hematology parameters included: Activated partial thromboplastin time (aPTT), hemoglobin, neutrophil count, white blood cell (WBC) count, lymphocyte count, platelet count and prothrombin international normalized ratio (INR). Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported. | Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) refers to number of participants analyzed for each specified parameter. | Posted | Count of Participants | Participants | 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) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B | Number of participants with clinical abnormalities in chemistry laboratory parameters were reported. Chemistry parameters included: sodium, aspartate aminotransferase (AST), potassium, alanine aminotransferase (ALT), creatinine, total bilirubin (BL), alkaline phosphatase, albumin, and calcium. Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported. | Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. | Posted | Count of Participants | Participants | From start of treatment (Day 1) up to 30 days after last dose of study drug (up to 12 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm | Number of participants with clinical abnormalities in chemistry laboratory parameters were reported. Chemistry parameters included: sodium, aspartate aminotransferase (AST), potassium, alanine aminotransferase (ALT), creatinine, total bilirubin, alkaline phosphatase, albumin, and calcium. Abnormality criteria was assessed as per NCI CTCAE v5.0 grading, where Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening. Grade 0 was assigned when the laboratory value was not assigned a Grade 1 or higher. Only those categories in which at least 1 participant had data were reported. | Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) refers to number of participants analyzed for each specified parameter. | Posted | Count of Participants | Participants | 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) |
|
Arm A1, A2, A3 and B: 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); Monotherapy arm: 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)
Arm A1, A2, A3 and B: Safety population was defined as all randomized participants of arms A1, A2, A3 and B who received at least 1 dose of any ibrutinib dosage level or control drug. Monotherapy population was defined as participants who were randomized to Arms A2, A3 and B and later switched to ibrutinib 560 mg QD monotherapy.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 560 milligrams (mg; 4 capsules of 140 mg) orally once daily (QD) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 milligrams per meter square (mg/m^2) intravenous (IV) infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. | 1 | 10 | 4 | 10 | 10 | 10 |
| EG001 | Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. | 0 | 9 | 3 | 9 | 7 | 9 |
| EG002 | Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. | 1 | 8 | 2 | 8 | 8 | 8 |
| EG003 | Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2 | Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance [CrCl] was 30 to less than [<] 60 milliliters per minute [mL/min]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. | 2 | 9 | 5 | 9 | 8 | 9 |
| EG004 | Monotherapy Arm: Ibrutinib 560 mg | Participants from Arm A2 (Ibrutinib 420 mg QD + Rituximab), Arm A3 (Ibrutinib 140 mg BID + Rituximab) and Arm B (Lenalidomide 20 mg + Rituximab) who were earlier receiving ibrutinib/lenalidomide + rituximab later switched to ibrutinib monotherapy post protocol amendment 1 (dated 08 June 2023), received ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. | 0 | 9 | 1 | 9 | 4 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Adenocarcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Papillary Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Cerebellar Haemorrhage | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Conjunctivitis Allergic | Eye disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Ocular Hyperaemia | Eye disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Periorbital Oedema | Eye disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Extravasation | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Infusion Site Rash | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Puncture Site Haematoma | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Body Tinea | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Fungal Foot Infection | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Soft Tissue Infection | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Blood Immunoglobulin M Decreased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase Decreased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Neutrophil Count Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Platelet Count Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Glucose Tolerance Impaired | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Iron Deficiency | Metabolism and nutrition disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Meningioma Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Tumour Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Epiglottic Cyst | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Oropharyngeal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Erythema Multiforme | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Nail Bed Inflammation | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Aortic Dilatation | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director Clinical Sciences Onc | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2023 | Dec 31, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551803 | ibrutinib |
| D000077269 | Lenalidomide |
| D000069283 | Rituximab |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| CZECH REPUBLIC |
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| GREECE |
|
| MALAYSIA |
|
| POLAND |
|
| SPAIN |
|
| TAIWAN |
|
| THAILAND |
|
| TURKEY |
|
| Discontinuation of Treatment Rituximab |
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| OG001 | Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| OG002 | Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| OG003 | Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2 | Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance [CrCl] was 30 to less than [<] 60 milliliters per minute [mL/min]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
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| OG001 | Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| OG002 | Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| OG003 | Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2 | Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance [CrCl] was 30 to less than [<] 60 milliliters per minute [mL/min]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
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|
| OG001 | Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| OG002 | Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| OG003 | Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2 | Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance [CrCl] was 30 to less than [<] 60 milliliters per minute [mL/min]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
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|
| OG001 | Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 420 mg (3 capsules of 140 mg) orally QD in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| OG002 | Arm A3: Ibrutinib 140 mg + Rituximab 375 mg/m^2 | Participants received ibrutinib 140mg (1 capsule of 140mg) orally twice daily (BID) in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD (unless the dose was previously reduced) until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
| OG003 | Arm B: Lenalidomide 20 mg (or 10 mg if CrCl Was 30 to <60 mL/Min) + Rituximab 375 mg/m^2 | Participants received lenalidomide 20 mg (or 10 mg if creatinine clearance [CrCl] was 30 to less than [<] 60 milliliters per minute [mL/min]) capsule orally QD on Days 1 through 21 in each 28-day treatment cycle starting from Cycle 1 Day 1 until disease progression or unacceptable toxicity. Participants also received rituximab 375 mg/m^2 IV infusion on Day 1 of each 28-day treatment cycle from Cycles 1 to 6. After implementation of Protocol Amendment 1 (dated 08 June 2023), all participants were given the option either to continue with the randomized treatment arm or switch to ibrutinib monotherapy to receive ibrutinib 560 mg capsules orally QD until the investigator determined that the participant was no longer benefiting from treatment (disease progression or unacceptable toxicity had occurred), the participant withdrew consent, alternative access to study treatment was available and feasible, or until the end of the study, whichever occurred earlier. |
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