A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma
GEMEINSCHAFTSPRAXIS - Haematologie & Onkologie 01307 Dresden (Sachsen) GermanyRekrutierend» Google-MapsArizona Health Sciences Center - The University of Arizona Cancer Center 85724 Tucson United StatesRekrutierend» Google-MapsUCLA Clinical and Translational Research Center (CTRC) 90095 Los Angeles United StatesRekrutierend» Google-Maps
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center 92868 Orange United StatesRekrutierend» Google-MapsInvestigative Clinical Research of Indiana, LLC 46062 Noblesville United StatesRekrutierend» Google-MapsKarmanos Cancer Institute 48201 Detroit United StatesRekrutierend» Google-MapsIcahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) 10029-6574 New York United StatesRekrutierend» Google-MapsStony Brook University Hospital 11794 Stony Brook United StatesRekrutierend» Google-MapsClinical Research Alliance Inc 11590 Westbury United StatesRekrutierend» Google-MapsUniversity of North Carolina Medical Center - UNC Hospitals Radiation Oncology Clinic 27514 Chapel Hill United StatesRekrutierend» Google-MapsLevine Cancer Institute 28204 Charlotte United StatesRekrutierend» Google-MapsUniversity Hospitals Cleveland Medical Center 44106 Cleveland United StatesRekrutierend» Google-MapsCenter for Oncology and Blood Disorders (COBD) 77030-2711 Houston United StatesRekrutierend» Google-MapsThe University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center 75701 Tyler United StatesRekrutierend» Google-MapsUniversity of Virginia Cancer Center 22908-0712 Charlottesville United StatesRekrutierend» Google-MapsProHealth Care Inc 53188 Waukesha United StatesRekrutierend» Google-MapsIcon Cancer Care, Wesley Clinic 4065 Auchenflower AustraliaRekrutierend» Google-MapsEpworth Freemasons Hospital 3002 East Melbourne AustraliaRekrutierend» Google-MapsSt Vincent Hospital Melbourne 3065 Fitzroy AustraliaRekrutierend» Google-MapsKrankenhaus der Elisabethinen Linz GmbH 4020 Linz AustriaRekrutierend» Google-MapsClinica Alemana de Santiago - Centro de Consultas y Diagnóstico 7570974 Las Condes ChileRekrutierend» Google-MapsInstituto Oncologico Fundacion Arturo Lopez Perez (FALP) 7500921 Providencia ChileRekrutierend» Google-MapsInmunocel 7580206 Las Condes ChileRekrutierend» Google-MapsFaculty Hospital Kralovske Vinohrady 100 34 Praha 10 CzechiaRekrutierend» Google-MapsFakultni Nemocnice Hradec Kralove 500 03 Hradec Kralove 5 CzechiaRekrutierend» Google-MapsIst Dept Medicine, 1st Fac Medicine, Charles University, General Hospital 12808 Praha CzechiaRekrutierend» Google-MapsCentre Hospitalier Universitaire d'Angers (CHU Angers) 49933 Angers FranceRekrutierend» Google-MapsHopital Victor Dupouy Argenteuil 95100 Argenteuil FranceRekrutierend» Google-MapsInstitut Paoli-Calmettes 13009 Marseille FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Nantes Hotel Dieu 44093 Nantes FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire (CHU) de Poitiers - Hopital de la Miletrie (Hopital Jean-Bernard) 86000 Poitiers FranceRekrutierend» Google-MapsInstitut de cancerologie Strasbourg Europe (ICANS) 67200 Strasbourg FranceRekrutierend» Google-MapsCHU de Tours - Hopital Bretonneau - Centre Henry Kaplan 37044 Tours Cedex 09 FranceRekrutierend» Google-MapsAssuta Ashdod Medical Center 7747629 Ashdod IsraelRekrutierend» Google-MapsBnai Zion Medical Center 31048 Haifa IsraelRekrutierend» Google-MapsSharett Institute Of Oncology, Hadassah Univ Hospital - Ein Karem, Hadassah Medical Organization 91120 Jerusalem IsraelRekrutierend» Google-MapsWestern Galilee Hospital 22100 Nahariya IsraelRekrutierend» Google-MapsRabin Medical Center 49100 Petah Tikva IsraelRekrutierend» Google-MapsThe Chaim Sheba Medical Center At Tel Hashomer, Sackler School Of Medicine, Tel Aviv University 5262000 Ramat-Gan IsraelRekrutierend» Google-MapsThe Tel Aviv Sourasky Medical Center 6423906 Tel-Aviv IsraelRekrutierend» Google-MapsUOC Ematologia e Terapia Cellulare - Ospedale Generale Provinciale C. 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Maria delle Croci di Ravenna 48121 Ravenna ItalyRekrutierend» Google-MapsHematology Clinic ASUFC 33100 Udine ItalyRekrutierend» Google-MapsPratia MCM Krakow 30-510 Krakow PolandRekrutierend» Google-MapsPratia Onkologia Katowice 40-519 Katowice PolandRekrutierend» Google-MapsCentrum Medyczne Pratia Poznan 60185 Skorzewo PolandRekrutierend» Google-MapsComplejo Hospitalario Universitario A Coruna 15006 A Coruna SpainRekrutierend» Google-MapsHospital Universitario Vall d'Hebron 08035 Barcelona SpainRekrutierend» Google-MapsHospital Universitario Virgen de las Nieves 18014 Granada SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Maranon (HGUGM) 28007 Madrid SpainRekrutierend» Google-MapsClinica Universidad de Navarra 28022 Madrid SpainRekrutierend» Google-MapsHospital Universitario Fundacion Jimenez Diaz 28040 Madrid SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre 28041 Madrid SpainRekrutierend» Google-MapsHospital HM Sanchinarro 28050 Madrid SpainRekrutierend» Google-MapsHospital Universitario Virgen de la Victoria 29010 Malaga SpainRekrutierend» Google-MapsHospital General Universitario Morales Meseguer 30008 Murcia SpainRekrutierend» Google-MapsHospital Universitario Central de Asturias 33011 Oviedo SpainRekrutierend» Google-MapsHospital Universitari Son Espases 07120 Palma de Mallorca SpainRekrutierend» Google-MapsClinica Universidad de Navarra 31008 Pamplona SpainRekrutierend» Google-MapsHospital Universitario de Navarra 31008 Pamplona SpainRekrutierend» Google-MapsUniversity Hospital Quironsalud Madrid 28223 Pozuelo de Alarcon SpainRekrutierend» Google-MapsHospital Clinico Universitario de Salamanca 37007 Salamanca SpainRekrutierend» Google-MapsHospital Universitario Marques De Valdecilla 39008 Santander SpainRekrutierend» Google-MapsHospital Clinico Universitario De Santiago De Compostela 15706 Santiago De Compostela SpainRekrutierend» Google-MapsHospital Universitario Virgen Macarena 41009 Sevilla SpainRekrutierend» Google-MapsHospital Universitario Virgen del Rocio 41013 Sevilla SpainRekrutierend» Google-MapsHospital Universitario Virgen de Valme 41014 Sevilla SpainRekrutierend» Google-MapsComplejo Hospitalario de Toledo (CHT) Hospital Virgen de la Salud (HVS) Hospital Universitario de Toledo 45007 Toledo SpainRekrutierend» Google-MapsHospital Clinico Universitario de Valencia 46010 Valencia SpainRekrutierend» Google-MapsUniversitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) 46026 Valencia SpainRekrutierend» Google-MapsKantonsspital Baden AG (KSB) 5400 Baden SwitzerlandRekrutierend» Google-MapsUniversity Hospital Basel 4031 Basel SwitzerlandRekrutierend» Google-MapsKantonsspital St. Gallen 9007 St. Gallen SwitzerlandRekrutierend» Google-MapsKantonsspital Winterthur (KSW) 8401 Winterthur SwitzerlandRekrutierend» Google-MapsChanghua Christian Hospital (CCH) 50006 Changhua City TaiwanRekrutierend» Google-MapsChang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital 61363 Puzi City TaiwanRekrutierend» Google-MapsTri-Service General Hospital 114202 Neihu TaiwanRekrutierend» Google-MapsKaohsiung Medical University 807 Kaohsiung TaiwanRekrutierend» Google-MapsTaipei Medical University Shuang Ho Hospital 23561 New Taipei TaiwanRekrutierend» Google-MapsTaipei Municipal WanFang Hospital 11696 Taipei City TaiwanRekrutierend» Google-MapsNational Taiwan University Hospital 100 Taipei TaiwanRekrutierend» Google-MapsChang Gung Medical Foundation Linkou Chang Gung Memorial Hospital 333 Taoyuan TaiwanRekrutierend» Google-MapsDr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 06200 Ankara TurkeyRekrutierend» Google-MapsGazi University Medical Faculty 06560 Ankara TurkeyRekrutierend» Google-MapsIstanbul University Capa Faculty of Medicine 34093 Istanbul TurkeyRekrutierend» Google-MapsAmerican Hospital 34365 Istanbul TurkeyRekrutierend» Google-MapsEge University hospital 35100 Izmir TurkeyRekrutierend» Google-MapsErciyes University Medical Faculty 38039 Kayseri TurkeyRekrutierend» Google-MapsSakarya University Training and Research Hospital 54290 Sakarya TurkeyRekrutierend» Google-MapsNamik Kemal Universitesi 59030 Tekirdag TurkeyRekrutierend» Google-MapsDerriford Hospital - University Hospitals Plymouth NHS Trust PL6 8DH Plymouth United KingdomRekrutierend» Google-MapsNorfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust NR4 7UY Norwich United KingdomRekrutierend» Google-MapsBeatson West of Scotland Cancer Centre - Greater Glasgow Health Board G12 0YN Glasgow United KingdomRekrutierend» Google-MapsQueens Hospital - Barking, Havering and Redbridge University Hospitals NHS Trust RM7 0AG Romford United KingdomRekrutierend» Google-MapsRoyal Cornwall Hospital NHS Trust TR1 3LQ Truro United KingdomRekrutierend» Google-Maps
1. Incidence of dose-limiting toxicities (DLTs) for odronextamab (Time Frame - Up to 35 days): Part 1
2. Incidence of treatment-emergent adverse events (TEAEs) of odronextamab (Time Frame - Up to 2 years): Part 1
3. Severity of TEAEs of odronextamab (Time Frame - Up to 2 years): Part 1
4. Complete Response at 30 months (CR30) as assessed by independent central review (Time Frame - Up to 30 months): Part 2
Secondary outcome:
1. Concentrations of odronextamab in serum (Time Frame - Up to 30 months): Part 1
2. Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration (Time Frame - Up to 30 months): Part 1
3. Titer of ADAs to odronextamab over the study duration (Time Frame - Up to 30 months): Part 1
4. Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration (Time Frame - Up to 30 months): Part 1
5. Objective response as assessed by the investigator (Time Frame - Up to 30 months): Part 1
6. Progression-free survival (PFS) as assessed by independent central review (Time Frame - Up to 5 years): Part 2
7. Event-free survival (EFS) as assessed by independent central review (Time Frame - Up to 5 years): Part 2
8. CR30 as assessed by local investigator (Time Frame - Up to 30 months): Part 2
9. Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)] (Time Frame - Up to 5 years): Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive,
emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting),
a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea,
insomnia, shortness of breath, appetite loss and financial difficulties). For the
functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7
= "excellent" with higher scores indicate better functioning; for the symptom scales,
scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher
symptom burden.
10. Overall survival (OS) (Time Frame - Up to 5 years): Part 2
11. PFS as assessed by the local investigator (Time Frame - Up to 5 years): Part 2
12. EFS as assessed by the local investigator (Time Frame - Up to 5 years): Part 2
13. Objective response assessed by local investigator (Time Frame - Up to 30 months): Part 2
14. Objective response assessed by independent central review (Time Frame - Up to 30 months): Part 2
15. Duration of response (DOR) assessed by independent central review (Time Frame - Up to 5 years): Part 2
16. DOR assessed by local investigator (Time Frame - Up to 5 years): Part 2
17. Time to next anti-lymphoma treatment (TTNT) (Time Frame - Up to 5 years): Part 2
18. Incidence of TEAEs (Time Frame - Up to 2 years): Part 2
19. Severity of TEAEs (Time Frame - Up to 2 years): Part 2
20. Odronextamab concentrations in serum during the induction period (Time Frame - Up to 30 months): Part 2
21. Odronextamab concentrations in serum during the maintenance period (Time Frame - Up to 30 months): Part 2
22. Incidence of ADAs to odronextamab over the study duration (Time Frame - Up to 30 months): Part 2
23. Titer of ADAs to odronextamab over the study duration (Time Frame - Up to 30 months): Part 2
24. Incidence of NAbs to odronextamab over the study duration (Time Frame - Up to 30 months): Part 2
25. Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30 (Time Frame - Up to 5 years): Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive,
emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting),
a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea,
insomnia, shortness of breath, appetite loss and financial difficulties). For the
functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7
= "excellent" with higher scores indicate better functioning; for the symptom scales,
scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher
symptom burden.
26. Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS) (Time Frame - Up to 5 years): Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related
symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at
all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.
27. Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Severity (PGIS) (Time Frame - Up to 5 years): Part 2 The PGIS includes a single-item to assess how a patient perceives the overall
severity of cancer symptoms over the past 7 days. Patients will choose the response that
best describes the severity of their overall cancer symptoms with options on a 5-point
scale ranging from 1 (No symptoms) to 4 (Very Severe).
28. Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Change (PGIC) (Time Frame - Up to 5 years): Part 2 The PGIC item includes a single-item to assess how a patient perceives their
overall change in health status since the start of study treatment. Patients will choose
from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse);
1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little
Worse, 6-Moderately Worse, 7-Much Worse.
29. Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L) (Time Frame - Up to 5 years): Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue
scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions:
mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each
dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe
problems" and "extreme problems". The EQ VAS records the participant's self-rated health
on a vertical visual analogue scale where the endpoints are labeled "Best imaginable
health state" and "Worst imaginable health state".
30. Overall mean changes in scores PROs, as measured by the validated Functional Assessment of Cancer - General (FACT-G) global population 5 (GP5) question (Time Frame - Up to 5 years): Part 2 A single item GP5 of the validated FACT-G questionnaire will be used to assess
from the participant perspective the overall impact of treatment side-effect. The
question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).
31. Change in score of the GP5 item in the participant population (Time Frame - Up to 5 years): Part 2 A single item Global Population item 5 (GP5) of the validated FACT-G questionnaire
will be used to assess from the participant perspective the overall impact of treatment
side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to
"very much" (4).
Experimental: Odronextamab Part 1 is a safety run-in. All participants will receive odronextamab.
In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab
followed by odronextamab maintenance.
Active Comparator: Rituximab + Investigator's Choice Chemotherapy Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with
chemotherapy followed by rituximab maintenance.
Odronextamab (REGN1979): Administered by intravenous infusion (IV)
Rituximab (Rituxan): Rituximab will be administered by IV, or subcutaneously (SC)
Cyclophosphamide (Cytoxan): Administered by IV as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
(CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
Doxorubicin (Adriamycin): Administered by IV as part of CHOP chemotherapy
Vincristine (Oncovin): Administered by IV as part of CHOP, and CVP chemotherapy
Prednisone/prednisolone (Deltasone/Omnipred): Administered orally (PO) as part of CVP chemotherapy
Bendamustine (Treanda): Administered by IV as part of chemotherapy (Rituximab-Bendamustine)
Quelle: ClinicalTrials.gov
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"A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma"
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