Clinical trial • Phase III • Oncology

Mosunetuzumab for Relapsed/refractory follicular lymphoma | Follicular lymphoma

Phase III trial of Mosunetuzumab for Relapsed/refractory follicular lymphoma | Follicular lymphoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed/refractory follicular lymphoma | Follicular lymphoma
Trial Stage
Phase III
Drug Modality
Bispecific antibody | Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-10-2024
First CTIS Authorization Date
07-11-2024

Trial design

Randomised, open-label, mosunetuzumab + lenalidomide (intervention) vs rituximab + lenalidomide (comparator); doses/schedules not specified in record-controlled Phase III trial in Spain, Italy, Poland and others.

Randomised
Yes
Open Label
Yes
Comparator
Mosunetuzumab + Lenalidomide (intervention) vs Rituximab + Lenalidomide (comparator); doses/schedules not specified in record
Target Sample Size
324

Eligibility

Recruits 324 Vulnerable population selected. Multiple subject information and informed consent form documents are provided (several versions and languages listed). Specific details on assent or consent by a legally authorised representative are not provided in the record..

Pregnancy Exclusion
Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program
Vulnerable Population
Vulnerable population selected. Multiple subject information and informed consent form documents are provided (several versions and languages listed). Specific details on assent or consent by a legally authorised representative are not provided in the record.

Inclusion criteria

  • {"criterion_text":"- Histologically documented CD20 + follicular lymphoma (FL) (Grades 1-3a)"}
  • {"criterion_text":"- Requiring systemic therapy assessed by investigator based on tumor size and/or Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria"}
  • {"criterion_text":"- Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy"}
  • {"criterion_text":"- Availability of a representative tumor specimen and the corresponding pathology report at the time of relapse/persistence for confirmation of the diagnosis of FL"}
  • {"criterion_text":"- Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program"}
  • {"criterion_text":"- Adequate hematologic and organ function"}

Exclusion criteria

  • {"criterion_text":"- Any history of Grade 3b FL and transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL or transformed FL)"}
  • {"criterion_text":"- Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1"}
  • {"criterion_text":"- Documented refractoriness to lenalidomide, defined as no response within 6 months of therapy"}
  • {"criterion_text":"- Positive SARS-CoV-2 test within 7 days prior to enrollment."}
  • {"criterion_text":"- Known or suspected history of central nervous system (CNS) lymphoma or leptomeningeal infiltration, HLH (hemophagocytic lymphohistiocytosis) and progressive multifocal leukoencephalopathy (PML)"}
  • {"criterion_text":"- Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to, significant cardiovascular disease or significant pulmonary disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Arm A and Arm B : 1. Progression-free survival as determined by the IRC with use of the 2014 Lugano Response Criteria or death from any cause in the intent-to-treat (ITT) population","definition_or_measurement_approach":"Progression-free survival as determined by the Independent Review Committee (IRC) using the 2014 Lugano Response Criteria or death from any cause in the ITT population."}
  • {"endpoint_text":"- Arm C : 2. Objective response rate, as defined as the proportion of patients whose best overall response is a PR or a CR during the study, as determined by the IRC","definition_or_measurement_approach":"Objective response rate (ORR) defined as the proportion of patients whose best overall response is a partial response (PR) or complete response (CR) during the study, as determined by the IRC."}

Secondary endpoints

  • {"endpoint_text":"- 1. Arm A and Arm B: Progression-free survival as determined by the investigator in the ITT population. Arm C: Progression-free survival as determined by the investigator and IRC in the ITT population.","definition_or_measurement_approach":"Investigator-assessed PFS in ITT; for Arm C both investigator and IRC assessments."}
  • {"endpoint_text":"- 2. Arm A, Arm B and Arm C: Complete response rate in the ITT population as determined by the IRC and investigator","definition_or_measurement_approach":"Complete response rate (CR) assessed by IRC and investigator in the ITT population."}
  • {"endpoint_text":"- 3. Arm A, Arm B and Arm C: Objective response rate in the ITT population as determined by the IRC and investigator","definition_or_measurement_approach":"Objective response rate (ORR) assessed by IRC and investigator in the ITT population."}
  • {"endpoint_text":"- 4. Arm A, Arm B and Arm C: Overall survival in the ITT population","definition_or_measurement_approach":"Overall survival measured in the ITT population (time to death from any cause)."}
  • {"endpoint_text":"- 5. Arm A, Arm B and Arm C: Duration of objective response (DOR)","definition_or_measurement_approach":"Duration of objective response measured from initial response until progression or death."}
  • {"endpoint_text":"- 6. Arm A, Arm B and Arm C: Duration of CR","definition_or_measurement_approach":"Duration of complete response measured from time of CR until progression or relapse."}
  • {"endpoint_text":"- 7. Arm A, Arm B and Arm C: Time to deterioration in physical functioning as measured by the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)","definition_or_measurement_approach":"Time to deterioration in physical functioning measured by EORTC QLQ-C30."}
  • {"endpoint_text":"- 8. Arm A, Arm B and Arm C: Time to deterioration in fatigue, as measured by the EORTC QLQC30","definition_or_measurement_approach":"Time to deterioration in fatigue measured by EORTC QLQ-C30."}
  • {"endpoint_text":"- 9. Arm A, Arm B and Arm C: Time to deterioration in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)","definition_or_measurement_approach":"Time to deterioration in lymphoma symptoms measured by FACT-LymS."}
  • {"endpoint_text":"- 10. Arm A, Arm B and Arm C : Time to new anti-lymphoma treatment (TTNALT), defined as the time from randomization to the first documented administration of a new anti-lymphoma treatment","definition_or_measurement_approach":"TTNALT defined as time from randomization to first documented administration of a new anti-lymphoma treatment."}
  • {"endpoint_text":"- 11. Arm A, Arm B and Arm C: Incidence and severity of adverse events, with severity determined according to the NCI CTCAE, v5.0, including cytokine release syndrome (CRS), with severity determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS grading criteria","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v5.0; CRS graded per ASTCT CRS grading criteria."}
  • {"endpoint_text":"- 12. Arm A, Arm B and Arm C: Change from baseline in targeted vital signs","definition_or_measurement_approach":"Change from baseline in targeted vital signs (unspecified specific vitals in record)."}
  • {"endpoint_text":"- 13. Arm A, Arm B and Arm C: Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in specified clinical laboratory test results."}
  • {"endpoint_text":"- 14. Arm A, Arm B and Arm C: Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events","definition_or_measurement_approach":"Tolerability assessed by dose interruptions, dose reductions, dose intensity, and discontinuations due to AEs."}
  • {"endpoint_text":"- 15. Arm A, Arm B and Arm C: Minimum observed concentration (Cmin) of Mosunetuzumab","definition_or_measurement_approach":"Pharmacokinetic endpoint: observed Cmin of mosunetuzumab."}
  • {"endpoint_text":"- 16. Arm A, Arm B and Arm C: Cmin of Lenalidomide","definition_or_measurement_approach":"Pharmacokinetic endpoint: observed Cmin of lenalidomide."}
  • {"endpoint_text":"- 17. Arm A, Arm B and Arm C: Maximum observed concentration (Cmax) of Mosunetuzumab","definition_or_measurement_approach":"Pharmacokinetic endpoint: observed Cmax of mosunetuzumab."}
  • {"endpoint_text":"- 18. Arm A, Arm B and Arm C: Cmax of Lenalidomide","definition_or_measurement_approach":"Pharmacokinetic endpoint: observed Cmax of lenalidomide."}
  • {"endpoint_text":"- 19. Arm A, Arm B and Arm C: Area under the concentration-time curve (AUC) of Mosunetuzumab","definition_or_measurement_approach":"Pharmacokinetic endpoint: AUC of mosunetuzumab."}
  • {"endpoint_text":"- 20. Arm A, Arm B and Arm C: AUC of Lenalidomide","definition_or_measurement_approach":"Pharmacokinetic endpoint: AUC of lenalidomide."}
  • {"endpoint_text":"- 21. Arm A, Arm B and Arm C: Prevalence of anti-drug antibodies (ADAs) against mosunetuzumab at baseline","definition_or_measurement_approach":"Immunogenicity endpoint: prevalence of anti-drug antibodies (ADAs) against mosunetuzumab at baseline."}
  • {"endpoint_text":"- 22. Arm A and Arm B: Prevalence of ADAs against rituximab at baseline","definition_or_measurement_approach":"Immunogenicity endpoint: prevalence of ADAs against rituximab at baseline."}
  • {"endpoint_text":"- 23. Arm A, Arm B and Arm C: Incidence of ADAs against mosunetuzumab during the study","definition_or_measurement_approach":"Incidence of treatment-emergent ADAs against mosunetuzumab during the study."}
  • {"endpoint_text":"- 24. Arm A and Arm B: Incidence of ADAs against rituximab during the study","definition_or_measurement_approach":"Incidence of ADAs against rituximab during the study."}
  • {"endpoint_text":"- 25. Arm A and Arm B: Cmin of Rituximab","definition_or_measurement_approach":"Pharmacokinetic endpoint: observed Cmin of rituximab."}
  • {"endpoint_text":"- 26. Arm A and Arm B: Cmax of Rituximab","definition_or_measurement_approach":"Pharmacokinetic endpoint: observed Cmax of rituximab."}
  • {"endpoint_text":"- 27. Arm A and Arm B: AUC of Rituximab","definition_or_measurement_approach":"Pharmacokinetic endpoint: AUC of rituximab."}

Recruitment

Planned Sample Size
324
Recruitment Window Months
88
Consent Approach
Informed consent required from participants. Multiple subject information and informed consent form documents are provided (versions / translations listed: English, French, German, Spanish, Italian, Polish). No specific details on assent or consent by legally authorised representatives are provided in the record.

Geography

Total Number Of Sites
42
Total Number Of Participants
150

Spain

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
07-11-2024
Processing Time Days
7
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Hospital General Universitario Morales Meseguer
Department Name
Hematology
Principal Investigator Name
Elena Pérez Ceballos
Principal Investigator Email
epceballos@gmail.com
Contact Person Name
Elena Pérez Ceballos
Contact Person Email
epceballos@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Fátima De La Cruz Vicente
Principal Investigator Email
fatimadelacruzv@gmail.com
Contact Person Name
Fátima De La Cruz Vicente
Contact Person Email
fatimadelacruzv@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hematology
Principal Investigator Name
María José Terol Castera
Principal Investigator Email
terol_mjo@gva.es
Contact Person Name
María José Terol Castera
Contact Person Email
terol_mjo@gva.es
Site Name
Hospital Universitario Donostia
Department Name
Hematology
Principal Investigator Name
Izaskun Zeberio Etxetxipia
Principal Investigator Email
izaskun.zeberioetxetxipia@osakidetza.eus
Contact Person Name
Izaskun Zeberio Etxetxipia
Site Name
Hospital Universitario La Paz
Department Name
Hematology
Principal Investigator Name
Víctor Jiménez Yuste
Principal Investigator Email
vjyuste@gmail.com
Contact Person Name
Víctor Jiménez Yuste
Contact Person Email
vjyuste@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
18
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
U.O. Ematologia I
Principal Investigator Name
Caterina Patti
Principal Investigator Email
k.patti@ospedaliriunitipalermo.it
Contact Person Name
Caterina Patti
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
U.O. di Ematologia di Ravenna
Principal Investigator Name
Monica Tani
Principal Investigator Email
monica.tani@auslromagna.it
Contact Person Name
Monica Tani
Contact Person Email
monica.tani@auslromagna.it
Site Name
Careggi University Hospital
Department Name
Dipartimento di Medicina Sperimentale e Clinica
Principal Investigator Name
Luca Nassi
Principal Investigator Email
nassil@aou-careggi.toscana.it
Contact Person Name
Luca Nassi
Contact Person Email
nassil@aou-careggi.toscana.it
Site Name
Azienda Ospedale-Universita Padova
Department Name
U.O.C Ematologia dell’A.O. Università di Padova
Principal Investigator Name
Francesco Piazza
Principal Investigator Email
francesco.piazza@unipd.it
Contact Person Name
Francesco Piazza
Contact Person Email
francesco.piazza@unipd.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
SOD Clinica Ematologica
Principal Investigator Name
Guido Gini
Principal Investigator Email
guido.gini@ospedaliriuniti.marche.it
Contact Person Name
Guido Gini
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Istituto di Ematologia “Seràgnoli” - Centro Ricerche Cliniche
Principal Investigator Name
Pier Luigi Zinzani
Principal Investigator Email
pierluigi.zinzani@unibo.it
Contact Person Name
Pier Luigi Zinzani
Contact Person Email
pierluigi.zinzani@unibo.it
Site Name
Azienda Ospedaliero-Universitaria Di Ancona (Via Conca 71)
Department Name
U.O. di Ematologia di Ancona
Principal Investigator Name
Guido Gini
Principal Investigator Email
guido.gini@ospedaliriuniti.marche.it
Contact Person Name
Guido Gini

Poland

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
11-11-2024
Processing Time Days
11
Number Of Sites
6
Number Of Participants
22

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddzial Hematologii i Transplantacji Szpiku
Principal Investigator Name
Lidia Gil
Principal Investigator Email
lidia.gil@usk.poznan.pl
Contact Person Name
Lidia Gil
Contact Person Email
lidia.gil@usk.poznan.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Principal Investigator Name
Tomasz Wrobel
Principal Investigator Email
badaniakliniczne-khn@usk.wroc.pl
Contact Person Name
Tomasz Wrobel
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Michal Taszner
Principal Investigator Email
mtaszner@uck.gda.pl
Contact Person Name
Michal Taszner
Contact Person Email
mtaszner@uck.gda.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddzial Hematologii i Transplantacji Szpiku
Principal Investigator Name
Adam Witkowski
Principal Investigator Email
info.onkocwbk@szpitalepomorskie.eu
Contact Person Name
Adam Witkowski
Site Name
Instytut Hematologii I Transfuzjologii
Department Name
Klinika Hematologii oraz oddział badań klinicznych
Principal Investigator Name
Ewa Lech-Maranda
Principal Investigator Email
bad_klin@ihit.waw.pl
Contact Person Name
Ewa Lech-Maranda
Contact Person Email
bad_klin@ihit.waw.pl
Site Name
Pratia Hematologia Sp. z o.o.
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
martyna.dzik@pratia.com
Contact Person Name
Sebastian Grosicki
Contact Person Email
martyna.dzik@pratia.com

France

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
03-12-2024
Processing Time Days
33
Number Of Sites
18
Number Of Participants
73

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hématologie
Principal Investigator Name
Benoit Tessoulin
Principal Investigator Email
Benoit.TESSOULIN@chu-nantes.fr
Contact Person Name
Benoit Tessoulin
Contact Person Email
Benoit.TESSOULIN@chu-nantes.fr
Site Name
Hopital Saint Louis
Department Name
Hématologie
Principal Investigator Name
Catherine Thieblemont
Principal Investigator Email
catherine.thieblemont@aphp.fr
Contact Person Name
Catherine Thieblemont
Contact Person Email
catherine.thieblemont@aphp.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hématologie
Principal Investigator Name
Stéphanie Guidez
Principal Investigator Email
Stephanie.GUIDEZ@chu-poitiers.fr
Contact Person Name
Stéphanie Guidez
Site Name
Hopital Saint Antoine
Department Name
Hématologie
Principal Investigator Name
Nicolas Stocker
Principal Investigator Email
nicolas.stocker@aphp.fr
Contact Person Name
Nicolas Stocker
Contact Person Email
nicolas.stocker@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hématologie
Principal Investigator Name
Roch HOUOT
Principal Investigator Email
Roch.HOUOT@chu-rennes.fr
Contact Person Name
Roch HOUOT
Contact Person Email
Roch.HOUOT@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des maladies du sang
Principal Investigator Name
Franck Morschhauser
Principal Investigator Email
franck.morschhauser@chu-lille.fr
Contact Person Name
Franck Morschhauser
Site Name
CHU de Montpellier
Department Name
Hématologie
Principal Investigator Name
Guillaume Cartron
Principal Investigator Email
g-cartron@chu-montpellier.fr
Contact Person Name
Guillaume Cartron
Contact Person Email
g-cartron@chu-montpellier.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Hématologie
Principal Investigator Name
Jehan Dupuis
Principal Investigator Email
jehan.dupuis@aphp.fr
Contact Person Name
Jehan Dupuis
Contact Person Email
jehan.dupuis@aphp.fr
Site Name
Centre Hospitalier Metropole Savoie
Department Name
Hématologie
Principal Investigator Name
Arthur Dony
Principal Investigator Email
arthur.dony@ch-metropole-savoie.fr
Contact Person Name
Arthur Dony
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Hématologie
Principal Investigator Name
Agathe Waulthier
Principal Investigator Email
agathe.waultier.rascalou@chu-nimes.fr
Contact Person Name
Agathe Waulthier
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hématologie
Principal Investigator Name
Krimo Bouadallah
Principal Investigator Email
krimo.bouabdallah@chu-bordeaux.fr
Contact Person Name
Krimo Bouadallah
Site Name
Centre Henri Becquerel
Department Name
Hématologie
Principal Investigator Name
Hervé Tilly
Principal Investigator Email
herve.tilly@chb.unicancer.fr
Contact Person Name
Hervé Tilly
Contact Person Email
herve.tilly@chb.unicancer.fr
Site Name
Institut Paoli Calmettes
Department Name
Hématologie
Principal Investigator Name
Jean-Marc Schiano de Collela
Principal Investigator Email
SCHIANOJM@ipc.unicancer.fr
Contact Person Name
Jean-Marc Schiano de Collela
Contact Person Email
SCHIANOJM@ipc.unicancer.fr
Site Name
Hospices Civils De Lyon
Department Name
Hématologie
Principal Investigator Name
Emmanuel Bachy
Principal Investigator Email
emmanuel.bachy@chu-lyon.fr
Contact Person Name
Emmanuel Bachy
Contact Person Email
emmanuel.bachy@chu-lyon.fr
Site Name
Centre Antoine Lacassagne
Department Name
Hématologie
Principal Investigator Name
Luca Inchiappa
Principal Investigator Email
luca.inchiappa@nice.unicancer.fr
Contact Person Name
Luca Inchiappa
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hématologie
Principal Investigator Name
Luc-Matthieu Fornecker
Principal Investigator Email
lm.fornecker@icans.eu
Contact Person Name
Luc-Matthieu Fornecker
Contact Person Email
lm.fornecker@icans.eu
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Hématologie
Principal Investigator Name
Sophie Bernard
Principal Investigator Email
sbernard@ch-cotebasque.fr
Contact Person Name
Sophie Bernard
Contact Person Email
sbernard@ch-cotebasque.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Hématologie
Principal Investigator Name
Eric Durot
Principal Investigator Email
edurot@chu-reims.fr
Contact Person Name
Eric Durot
Contact Person Email
edurot@chu-reims.fr

Germany

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
13
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Hämatologie und Internistische Onkologie
Principal Investigator Name
Stephanie Mayer
Principal Investigator Email
stephanie.mayer@ukr.de
Contact Person Name
Stephanie Mayer
Contact Person Email
stephanie.mayer@ukr.de
Site Name
Rostock University Medical Center
Department Name
Innere Medizin und Hämatologie/Onkologie
Principal Investigator Name
Sebastian Böttcher
Principal Investigator Email
sebastian.boettcher@med.uni-rostock.de
Contact Person Name
Sebastian Böttcher
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinik für Hämatologie, Onkologie und Rheumatologie
Principal Investigator Name
Julia Meißner
Principal Investigator Email
julia.meissner@med.uni-heidelberg.de
Contact Person Name
Julia Meißner
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Hämatologie, Onkologie
Principal Investigator Name
Thomas Weber
Principal Investigator Email
innere4@uk-halle.de
Contact Person Name
Thomas Weber
Contact Person Email
innere4@uk-halle.de
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Department Name
n.a.
Principal Investigator Name
Lutz Jacobasch
Principal Investigator Email
buero@onkologie-dresden.net
Contact Person Name
Lutz Jacobasch
Contact Person Email
buero@onkologie-dresden.net
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Innere Medizin - Hämatologie, Onkologie und Palliativmedizin
Principal Investigator Name
Christian Scholz
Principal Investigator Email
klinische.forschung@vivantes.de
Contact Person Name
Christian Scholz

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
Monitoring
Name
Pharmaceutical Product Development LLC
Name
Bioclinica Inc.
Responsibilities
Imaging
Name
Almac Clinical Technologies LLC

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"ePRO","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Mosunetuzumab
Active Substance
Mosunetuzumab
Modality
Bispecific antibody
Investigational Product Name
Lenalidomide
Active Substance
lenalidomide
Modality
Small molecule
Authorisation Status
Authorised
Investigational Product Name
Rituximab
Active Substance
rituximab
Modality
Monoclonal antibody
Authorisation Status
Authorised
Investigational Product Name
Tocilizumab
Active Substance
tocilizumab
Modality
Monoclonal antibody
Authorisation Status
Authorised
Combination Treatment
Yes

Related trials

Other published trials that may interest you.