VEGA: A Study of Ibrutinib With Rituximab in Relapsed/Refractory Mantle Cell Lymphoma
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the recommended dosage of ibrutinib when administered in combination with rituximab in participants with relapsed or refractory (r/r) mantle cell lymphoma (MCL) (Phase 2); and to compare the progression-free survival (PFS) of ibrutinib plus rituximab versus physician's choice of lenalidomide plus rituximab or bortezomib plus rituximab (Phase 3).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2/Phase 3 |
Detailed Description
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 that ibrutinib plus rituximab using the recommended Phase 3 dosage selected in the Phase 2 part will prolong PFS versus physician's choice of lenalidomide plus rituximab or bortezomib plus rituximab, in participants with r/r MCL who are BTKi naive. The study will include a Screening Phase (up to 30 days prior to randomization), a Treatment Phase (from randomization until study treatment discontinuation), and a Post-treatment Follow-up Phase (from treatment discontinuation until death, consent withdrawal, or study end, whichever occurs first). Safety assessments include adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, vital signs, electrocardiogram (ECG), physical examination. The total duration of the study will be up to 10 years 8 months.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Phase 2: Treatment Arm A1 (Rituximab plus Ibrutinib) 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). |
Drug: Ibrutinib
Ibrutinib capsules will be administered orally.
Other Names:
Drug: Rituximab
Rituximab will be administered IV.
|
Experimental: Phase 2: Treatment Arm A2 (Rituximab plus Ibrutinib) 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). |
Drug: Ibrutinib
Ibrutinib capsules will be administered orally.
Other Names:
Drug: Rituximab
Rituximab will be administered IV.
|
Experimental: Phase 2: Treatment Arm A3 (Rituximab plus Ibrutinib) 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). |
Drug: Ibrutinib
Ibrutinib capsules will be administered orally.
Other Names:
Drug: Rituximab
Rituximab will be administered IV.
|
Experimental: Phase 2: Treatment Arm B (Rituximab plus Lenalidomide or Bortezomib) 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. |
Drug: Lenalidomide
Lenalidomide capsules will be administered orally.
Drug: Rituximab
Rituximab will be administered IV.
Drug: Bortezomib
Bortezomib will be administered either intravenously or subcutaneously.
|
Experimental: Phase 3: Treatment Arm A (Rituximab plus Ibrutinib) Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 with recommended dose of ibrutinib identified in the Phase 2 starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days). |
Drug: Ibrutinib
Ibrutinib capsules will be administered orally.
Other Names:
Drug: Rituximab
Rituximab will be administered IV.
|
Experimental: Phase 3: Treatment Arm B (Rituximab plus Lenalidomide or Bortezomib) Participants will receive rituximab 375 mg/m^2 IV on Day 1 of Cycles 1 to 6 with physician's choice of either lenalidomide 20 mg orally, once daily from Day 1 through Day 21 of a 28-day cycle or bortezomib 1.3 mg/m^2 IV or SC on Days 1, 4, 8 and 11 of a 21-day cycle until disease progression or unacceptable toxicity. |
Drug: Lenalidomide
Lenalidomide capsules will be administered orally.
Drug: Rituximab
Rituximab will be administered IV.
Drug: Bortezomib
Bortezomib will be administered either intravenously or subcutaneously.
|
Outcome Measures
Primary Outcome Measures
- Phase 2: Complete Response Rate (CRR) [Up to 35 months]
CRR is defined as the percentage of participants who achieve complete response (CR) on or prior to the initiation of subsequent anticancer therapy according to Lugano 2014 criteria based on independent review committee (IRC) assessment.
- Phase 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Up to 35 months]
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
- Phase 2: Number of Participants with TEAEs by Severity [Up to 35 months]
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
- Phase 2: Number of Participants with Serious Adverse Events (SAEs) [Up to 35 months]
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
- Phase 2: Progression Free Survival (PFS) [Up to 35 months]
PFS is defined as the duration from the date of randomization to either disease progression based on IRC assessment or death, whichever comes first.
- Phase 3: Progression Free Survival (PFS) [Up to 60 months]
PFS is defined as the duration from the date of randomization to either disease progression based on IRC assessment or death, whichever comes first.
Secondary Outcome Measures
- Phase 3: Overall Response Rate (ORR) [Up to 60 months]
ORR is defined as the percentage of participants who achieve CR or partial response (PR) as the best overall response on or prior to initiation of subsequent antineoplastic therapy according to Lugano 2014 criteria based on IRC assessment.
- Phase 3: Overall Survival (OS) [Up to 129 months]
OS is defined as the time from the date of randomization to the date of the participant's death.
- Phase 3: Complete Response Rate (CRR) [Up to 60 months]
CRR is defined as the percentage of participants who achieve CR on or prior to the initiation of subsequent anticancer therapy according to Lugano 2014 criteria based on IRC assessment.
- Phase 3: Time-to-next Treatment (TTNT) [Up to 60 months]
TTNT is defined as interval from the date of randomization to the start date of any anti-mantle cell lymphoma (MCL) treatment subsequent to the study treatment.
- Phase 3: Number of Participants with AEs [Up to 60 months]
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study.
- Phase 3: Number of Participants with AEs by Severity [Up to 60 months]
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fundacao Pio XII | Barretos | Brazil | 14784-400 | |
2 | Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte | Brazil | 30150-221 | |
3 | Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia | Brasília | Brazil | 70200-730 | |
4 | Ynova Pesquisa Clinica | Florianopolis | Brazil | 88020-210 | |
5 | Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN | Florianopolis | Brazil | 88034-000 | |
6 | Instituto Do Cancer Do Ceara | Fortaleza | Brazil | 60430-230 | |
7 | Liga Norte Riograndense Contra O Cancer | Natal | Brazil | 59062-000 | |
8 | Complexo Hospitalar de Niterói | Niterói | Brazil | 24020-096 | |
9 | Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Brazil | 90050-170 | |
10 | Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP | Ribeirao Preto | Brazil | 14051-140 | |
11 | Oncoclínicas Rio de Janeiro S.A. | Rio de Janeiro | Brazil | 22250-905 | |
12 | Instituto de Ensino e Pesquisa São Lucas | Sao Paulo | Brazil | 01236-030 | |
13 | Instituto D'Or de Pesquisa e Ensino (IDOR) | Sao Paulo | Brazil | 04501-000 | |
14 | Hospital Das Clinicas Da Faculdade De Medicina Da USP | Sao Paulo | Brazil | 05403-000 | |
15 | Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | Sao Paulo | Brazil | 05651-900 | |
16 | Casa de Saúde Santa Marcelina - Hospital Santa Marcelina | Sao Paulo | Brazil | 08270-120 | |
17 | University Multiprofile Hospital For Active Treatment St George | Plovdiv | Bulgaria | 4002 | |
18 | Acibadem City Clinic Tokuda Hospital | Sofia | Bulgaria | 1407 | |
19 | UMHAT St. Ivan Rilski | Sofia | Bulgaria | 1431 | |
20 | Specialized Hospital for Active Treatment of Hematology Diseases EAD | Sofia | Bulgaria | 1797 | |
21 | Hunan Cancer hospital | Changsha | China | 410013 | |
22 | Sun Yat-Sen University Cancer Center | Guangzhou | China | 510060 | |
23 | The Second Affiliated Hospital of Kunming Medical University | Kunming | China | 650101 | |
24 | Linyi Cancer Hospital | Linyi | China | 276000 | |
25 | Jiangxi Provincial People's Hospital | Nanchang | China | 330006 | |
26 | Tianjin cancer hospital | Tianjin | China | 300060 | |
27 | Hubei province tumor hospital | Wuhan | China | 430079 | |
28 | CH Merkur | Zagreb | Croatia | 10000 | |
29 | Klinicki bolnicki centar Zagreb | Zagreb | Croatia | 10000 | |
30 | University Hospital Dubrava | Zagreb | Croatia | 10000 | |
31 | Fakultní nemocnice Olomouc | Olomouc | Czechia | 779 00 | |
32 | Fakultni nemocnice Ostrava | Ostrava | Czechia | 708 52 | |
33 | Fakultni nemocnice Kralovske Vinohrady | Praha 10 | Czechia | 100 34 | |
34 | General University Hospital in Prague | Praha 2 | Czechia | 128 08 | |
35 | Kuopio University Hospital | Kuopio | Finland | 70210 | |
36 | University Hospital of Alexandroupolis | Alexandroupoli | Greece | 68100 | |
37 | Attikon University General Hospital of Attica | Athens | Greece | 12462 | |
38 | University Hospital of Ioannina | Ioannina | Greece | 45110 | |
39 | Anticancer Hospital of Thessaloniki 'Theageneio' | Thessaloniki | Greece | 546 39 | |
40 | G.Papanikolaou | Thessaloniki | Greece | 57010 | |
41 | Queen Mary Hospital | Hong Kong | Hong Kong | 999077 | |
42 | Prince of Wales Hospital | New Territories | Hong Kong | 999077 | |
43 | Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely | Budapest | Hungary | 1097 | |
44 | Orszagos Onkologiai Intezet | Budapest | Hungary | 1122 | |
45 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | 4032 | |
46 | Petz Aladar Megyei Oktato Korhaz | Gyor | Hungary | 9024 | |
47 | Somogy Megyei Kaposi Mor Oktatokorhaz | Kaposvar | Hungary | 7400 | |
48 | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs | Hungary | 7623 | |
49 | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs | Hungary | 7624 | |
50 | Healthcare Global (HCG) Hospital | Bangalore | India | 560027 | |
51 | Post Graduate Institute of Medical Education & Research (PGIMER) | Chandigarh | India | 160012 | |
52 | Amrita Institute of Medical Sciences | Ernakulam | India | 682025 | |
53 | Artemis Hospital | Gurugram | India | 122001 | |
54 | Narayana Superspeciality Hospital, Howrah | Howrah | India | 711103 | |
55 | American Oncology Institute (Cancer Treatment Hospital) - Hyderabad | Hyderabad | India | 500019 | |
56 | Bhagwan Mahaveer Cancer Hospital & Research Centre | Jaipur | India | 302017 | |
57 | HCG cancer center | Jaipur | India | 302020 | |
58 | Tata Medical Center | Kolkata | India | 700156 | |
59 | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Lucknow | India | 226014 | |
60 | AMRI Hospital, Mukundapur | Mukundapur | India | 700099 | |
61 | Tata Memorial Hospital | Mumbai | India | 400012 | |
62 | HCG Manavta Cancer Centre | Nashik | India | 422002 | |
63 | Safdarjung Hospital | New Delhi | India | 110029 | |
64 | IMS and SUM Hospital | Odisha | India | 751003 | |
65 | Ruby Hall Clinic | Pune | India | 411001 | |
66 | Deenanath Mangeshkar Hospital and Research Centre | Pune | India | 411004 | |
67 | Synergy Superspeciality Hospital | Rajkot | India | 360005 | |
68 | Hospital Ampang | Ampang | Malaysia | 68000 | |
69 | Hospital Sultanah Aminah | Johor Bharu | Malaysia | 80100 | |
70 | Hospital Queen Elizabeth | Kota Kinabalu | Malaysia | 88586 | |
71 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | 59100 | |
72 | Subang Jaya Medical Centre | Subang Jaya | Malaysia | 47500 | |
73 | Hidra Investigación | Ciudad de México | Mexico | 04100 | |
74 | Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán | Ciudad de México | Mexico | 14080 | |
75 | Oncotech | La Paz | Mexico | 23040 | |
76 | Health Pharma Professional Research | Mexico | Mexico | 03100 | |
77 | Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | Mexico | 64460 | |
78 | Avix Investigacion Clinica, S.C. | Monterrey | Mexico | 64710 | |
79 | Hidra Investigación | Morelia | Mexico | 58260 | |
80 | Eme Red Hospitalaria | Mérida | Mexico | 97000 | |
81 | Oaxaca Site Management Organization S.C. | México | Mexico | 68000 | |
82 | Centro de Quimioterapia e Investigación | Tlajomulco de Zúñiga | Mexico | 45640 | |
83 | Hospital Nacional Daniel Alcides Carrion | Callao | Peru | 02 | |
84 | Unidad Oncológica Molecular Peruana | Lima | Peru | 15720 | |
85 | ONCOCARE | Lima | Peru | 85193 | |
86 | Hospital Nacional Edgardo Rebagliatti Martins | Lima | Peru | L11 | |
87 | Oncosalud | San Borja | Peru | 15036 | |
88 | Riverside Medical Center | Bacolod City | Philippines | 6100 | |
89 | Baguio General Hospital and Medical Center | Baguio | Philippines | 2600 | |
90 | Metro Davao Medical and Research Center Inc. | Davao City | Philippines | 8000 | |
91 | Philippine General Hospital | Manila | Philippines | 1000 | |
92 | The Medical City | Pasig | Philippines | 1600 | |
93 | ACE Medical Center Palawan | Puerto Princesa | Philippines | 5300 | |
94 | St. Luke's Medical Center | Quezon City | Philippines | 1112 | |
95 | East Avenue Medical Center | Quezon | Philippines | 1101 | |
96 | Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza | Brzozów | Poland | 36-200 | |
97 | Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach | Kielce | Poland | 25-734 | |
98 | Pratia MCM Krakow | Kraków | Poland | 30-510 | |
99 | Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | Poland | 93-513 | |
100 | Samodzielny Publiczny Szpital Kliniczny Nr 1 | Lublin | Poland | 20-081 | |
101 | Szpital Specjalistyczny im Jędrzeja Śniadeckiego w Nowym Saczu | Nowy Sącz | Poland | 33-300 | |
102 | SPZOZ Ministerstwa Spraw Wewnętrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie | Olsztyn | Poland | 10-228 | |
103 | Centrum Medyczne Pratia Poznan | Skorzewo | Poland | 60-185 | |
104 | Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof. Tadeusza Sokolowskiego | Szczecin | Poland | 71252 | |
105 | Specjalistyczny Szpital Onkologiczny Nu-Med | Tomaszów Mazowiecki | Poland | 97-200 | |
106 | MICS Centrum Medyczne Torun | Toruń | Poland | 87-100 | |
107 | Centrum Medyczne Warszawskiego Uniwersytetu Medycznego | Warszawa | Poland | 02-097 | |
108 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warszawa | Poland | 02-781 | |
109 | Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu | Wałbrzych | Poland | 58-309 | |
110 | Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw | Poland | 50-367 | |
111 | Hospital de Braga | Braga | Portugal | 4710-243 | |
112 | Centro Hospitalar Lisboa Ocidental - Hospital São Fracisco Xavier | Lisboa | Portugal | 1449-005 | |
113 | Instituto Portugues de Oncologia do Porto Francisco Gentil | Porto | Portugal | 4200-072 | |
114 | Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. | Vila Nova de Gaia | Portugal | 4434-502 | |
115 | Auxilio Mutuo Cancer Center | San Juan | Puerto Rico | 00918 | |
116 | Spitalul Clinic Coltea | Bucuresti | Romania | 030167 | |
117 | Ovidius Clinical Hospital OCH | Ovidiu | Romania | 905900 | |
118 | FNsP F. D. Roosevelta Banska Bystrica | Banska Bystrica | Slovakia | 975 17 | |
119 | Narodny onkologicky ustav | Bratislava | Slovakia | 833 10 | |
120 | FNsP J.A. Reimana Presov | Presov | Slovakia | 08181 | |
121 | Clinical Haematologist Groote Schuur Hospital (GSH) incorporating UCT Clinical Research Centre | Cape Town | South Africa | 7925 | |
122 | Inkosi Albert Luthuli Central Hospital | Durban | South Africa | 4091 | |
123 | Netcare Pretoria East Hospital | Pretoria | South Africa | 0181 | |
124 | Clinical Haematology | Western Cape | South Africa | 7580 | |
125 | Hosp. Reina Sofia | Cordoba | Spain | 14004 | |
126 | Hosp. Univ. Infanta Leonor | Madrid | Spain | 28031 | |
127 | Clinica Univ. De Navarra | Pamplona | Spain | 31008 | |
128 | Hosp. Quiron Madrid Pozuelo | Pozuelo de Alarcon | Spain | 28223 | |
129 | Hosp. Clinico Univ. de Salamanca | Salamanca | Spain | 37007 | |
130 | Falu Lasarett Medicinkliniken Falun | Falun | Sweden | 791 82 | |
131 | Sahlgrenska University Hospital | Göteborg | Sweden | 413 45 | |
132 | Universitetssjukhuset Linköping, Hematologkliniken, Linköping | Linkoping | Sweden | 581 85 | |
133 | Sunderby Sjukhus | Luleå | Sweden | 97180 | |
134 | Akademiska Sjukhuset | Uppsala | Sweden | 752 37 | |
135 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | Taiwan | 80756 | |
136 | China Medical University Hospital | Taichung | Taiwan | 404 | |
137 | Chi Mei Medical Center - Liu Ying | Tainan | Taiwan | 736 | |
138 | National Taiwan University Hospital | Taipei | Taiwan | 100 | |
139 | King Chulalongkorn Memorial Hospital | Bangkok | Thailand | 10330 | |
140 | Phramongkutklao Hospital and Medical College | Bangkok | Thailand | 10400 | |
141 | Ramathibodi Hospital | Bangkok | Thailand | 10400 | |
142 | Siriraj Hospital | Bangkok | Thailand | 10700 | |
143 | Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine | ChiangMai | Thailand | 50200 | |
144 | Srinagarind Hospital | Khon Kaen | Thailand | 40002 | |
145 | Ankara Sehir Hastanesi | Ankara Sehir Hastanesi | Turkey | 06800 | |
146 | Ondokuz Mayis Universitesi Tip Fakultesi | Atakum | Turkey | 55270 | |
147 | Trakya University Medical Faculty | Edirne | Turkey | 22030 | |
148 | Medipol Mega University Hospital | Istanbul | Turkey | 34214 | |
149 | Istanbul University | Istanbul | Turkey | 34390 | |
150 | Ege Universitesi Tip Fakultesi | Izmir | Turkey | 35100 | |
151 | Sakarya Egitim Ve Arastırma Hastanesi Korucuk Kampus | Sakarya | Turkey | 54290 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
- Pharmacyclics LLC.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109252
- 2022-000364-21
- 54179060MCL3004