Clinical trial • Phase III • Oncology
GLOFITAMAB for Diffuse large B-cell lymphoma | Relapsed/refractory diffuse large B-cell lymphoma
Phase III trial of GLOFITAMAB for Diffuse large B-cell lymphoma | Relapsed/refractory diffuse large B-cell lymphoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Diffuse large B-cell lymphoma | Relapsed/refractory diffuse large B-cell lymphoma
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 12-04-2024
- First CTIS Authorization Date
- 17-05-2024
Trial design
Randomised, open-label, arm 1: glofitamab + gemcitabine plus oxaliplatin (glofit-gemox); arm 2: rituximab + gemcitabine plus oxaliplatin (r-gemox). (no doses/schedules stated in the provided record.)-controlled Phase III trial in Denmark, Belgium, France and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arm 1: Glofitamab + Gemcitabine plus Oxaliplatin (Glofit-GemOx); Arm 2: Rituximab + Gemcitabine plus Oxaliplatin (R-GemOx). (No doses/schedules stated in the provided record.)
- Target Sample Size
- 160
Eligibility
Recruits 160 Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent or assent handling are provided in the supplied record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No further details on consent or assent handling are provided in the supplied record.
Inclusion criteria
- {"criterion_text":"- Life expectancy >= 12 weeks\n- Histologically confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS)\n- Relapsed/refractory disease\n- At least one (≥ 1) line of prior systemic therapy\n- Patients who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant\n- At least one bi-dimensionally measurable (>= 1.5 cm) nodal lesion, or one bi-dimensionally measurable (=> 1 cm) extranodal lesion, as measured on computed tomography (CT) scan"}
Exclusion criteria
- {"criterion_text":"- Patient has failed only one prior line of therapy and is a candidate for stem cell transplantation\n- Contraindication to Obinutuzumab, rituximab, gemcitabine or oxaliplatin, or tocilizumab\n- History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)\n- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines\n- Primary mediastinal B-cell lymphoma\n- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Overall Survival","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- 1. Progression-Free Survival by Independent review committee (IRC) and Investigator","definition_or_measurement_approach":"As stated: assessed by Independent Review Committee and Investigator"}
- {"endpoint_text":"- 2. Complete response rate by IRC and Investigator","definition_or_measurement_approach":"As stated: assessed by Independent Review Committee and Investigator"}
- {"endpoint_text":"- 3. Objective response rate by IRC and Investigator","definition_or_measurement_approach":"As stated: assessed by Independent Review Committee and Investigator"}
- {"endpoint_text":"- 4. Duration of objective response","definition_or_measurement_approach":""}
- {"endpoint_text":"- 5. Duration of complete response","definition_or_measurement_approach":""}
- {"endpoint_text":"- 6. Time to deterioration in physical functioning and fatigue, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life−Core 30 Questionnaire (EORTC QLQ-C30) and in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy−Lymphoma subscale (FACT-Lym LymS)","definition_or_measurement_approach":"Measured with EORTC QLQ-C30 and FACT-Lym LymS as specified"}
- {"endpoint_text":"- 7. Incidence and severity of adverse events, with severity determined according to 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 event severity per NCI CTCAE v5.0; CRS graded per ASTCT criteria"}
- {"endpoint_text":"- 8. Change from baseline in targeted vital signs","definition_or_measurement_approach":""}
- {"endpoint_text":"- 9. Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":""}
- {"endpoint_text":"- 10. Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events","definition_or_measurement_approach":""}
- {"endpoint_text":"- 11. Minimum serum concentration of glofitamab","definition_or_measurement_approach":""}
- {"endpoint_text":"- 12. Maximum serum concentration of glofitamab","definition_or_measurement_approach":""}
- {"endpoint_text":"- 13. Area under the concentration-time curve (AUC) for serum concentration−time profile of glofitamab estimated using a population-PK model","definition_or_measurement_approach":"Estimated using a population-PK model"}
- {"endpoint_text":"- 14. Minimum serum concentration of obinutuzumab","definition_or_measurement_approach":""}
- {"endpoint_text":"- 15. Maximum serum concentration of obinutuzumab","definition_or_measurement_approach":""}
- {"endpoint_text":"- 16. Prevalence of anti-drug antibodies (ADAs) against glofitamab at baseline and incidence of ADAs during the study","definition_or_measurement_approach":""}
Recruitment
- Registry Or Advocacy Recruitment
- True, organisations named: European Organisation For Research And Treatment Of Cancer (EORTC); FACIT.Org Inc.
- Planned Sample Size
- 160
- Recruitment Window Months
- 71
- Consent Approach
- Informed consent documented via subject information and informed consent forms (multiple language versions present including EN, FR, NL). No specific details on assent or age-specific consent processes are available in the supplied record.
Methods
- Patient Recruitment by Caerus Marketing Group LLC (justin.reed@studykik.com) — role listed: Patient Recruitment (no channels or country-specific approaches specified)
- Patient Recruitment by Axon Communications Inc. (info-tor@axon-com.com) — role listed: Patient Recruitment (no channels or country-specific approaches specified)
- Site materials and CRS education materials provided by Crux Product Design Limited (operations@cruproductdesign.com) — role listed: Site Materials, CRS Education Materials
- Recruitment/procedural materials referenced in multiple 'K1_Recruitment arrangements' documents (documents present) — specific channels or target audience not detailed in provided record
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 85
Denmark
- Earliest CTIS Part Ii Submission Date
- 26-04-2024
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 672
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Rigshospitalet
- Department Name
- Hematology
- Principal Investigator Name
- Peter Brown
- Principal Investigator Email
- pedebr01@heh.regionh.dk
- Contact Person Name
- Peter Brown
- Contact Person Email
- pedebr01@heh.regionh.dk
- Site Name
- Aarhus Universitet
- Department Name
- Hematology
- Principal Investigator Name
- Judit Jørgensen
- Principal Investigator Email
- judijoer@rm.dk
- Contact Person Name
- Judit Jørgensen
- Contact Person Email
- judijoer@rm.dk
Belgium
- Earliest CTIS Part Ii Submission Date
- 26-04-2024
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 672
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Hematology
- Principal Investigator Name
- Bernard De Prijck
- Principal Investigator Email
- bernard.deprijck@chu.liege.be
- Contact Person Name
- Bernard De Prijck
- Contact Person Email
- bernard.deprijck@chu.liege.be
- Site Name
- UZ Leuven
- Department Name
- Hematology
- Principal Investigator Name
- Daan Dierickx
- Principal Investigator Email
- daan.dierickx@uzleuven.be
- Contact Person Name
- Daan Dierickx
- Contact Person Email
- daan.dierickx@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 26-04-2024
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 675
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Hematologie clinique
- Principal Investigator Name
- Herve Ghesquieres
- Principal Investigator Email
- herve.ghesquieres@chu-lyon.fr
- Contact Person Name
- Herve Ghesquieres
- Contact Person Email
- herve.ghesquieres@chu-lyon.fr
- Site Name
- Institut Bergonie
- Department Name
- Hematologie Oncologie
- Principal Investigator Name
- Fontanet Bijou
- Principal Investigator Email
- f.bijou@bordeaux.unicancer.fr
- Contact Person Name
- Fontanet Bijou
- Contact Person Email
- f.bijou@bordeaux.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Hematologie
- Principal Investigator Name
- Franck MORSCHHAUSER
- Principal Investigator Email
- Franck.MORSCHHAUSER@chu-lille.fr
- Contact Person Name
- Franck MORSCHHAUSER
- Contact Person Email
- Franck.MORSCHHAUSER@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hematologie clinique
- Principal Investigator Name
- Charles Herbaux
- Principal Investigator Email
- c-herbaux@chu-montpellier.fr
- Contact Person Name
- Charles Herbaux
- Contact Person Email
- c-herbaux@chu-montpellier.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hémopathies Lymphoïdes
- Principal Investigator Name
- Corinne Haioun
- Principal Investigator Email
- corinne.haioun@aphp.fr
- Contact Person Name
- Corinne Haioun
- Contact Person Email
- corinne.haioun@aphp.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 26-04-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 677
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- 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
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Hematology
- Principal Investigator Name
- Fatima De la Cruz
- Principal Investigator Email
- fatimadelacruzv@gmail.com
- Contact Person Name
- Fatima De la Cruz
- Contact Person Email
- fatimadelacruzv@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Principal Investigator Name
- Armando Lopez-Guillermo
- Principal Investigator Email
- alopezg@clinic.cat
- Contact Person Name
- Armando Lopez-Guillermo
- Contact Person Email
- alopezg@clinic.cat
Germany
- Earliest CTIS Part Ii Submission Date
- 26-04-2024
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 675
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin III
- Principal Investigator Name
- Daniel Heudobler
- Principal Investigator Email
- daniel.heudobler@ukr.de
- Contact Person Name
- Daniel Heudobler
- Contact Person Email
- daniel.heudobler@ukr.de
Poland
- Earliest CTIS Part Ii Submission Date
- 26-04-2024
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 675
- Number Of Sites
- 4
- Number Of Participants
- 28
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Principal Investigator Name
- Jan Zaucha
- Principal Investigator Email
- klhem@gumed.edu.pl
- Contact Person Name
- Jan Zaucha
- Contact Person Email
- klhem@gumed.edu.pl
- Site Name
- Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Department Name
- Oddzial Kliniczny Hematologii
- Principal Investigator Name
- Janusz Hałka
- Principal Investigator Email
- janusz.halka@poliklinika.net
- Contact Person Name
- Janusz Hałka
- Contact Person Email
- janusz.halka@poliklinika.net
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
- Principal Investigator Name
- Tomasz Wróbel
- Principal Investigator Email
- badaniakliniczne-khn@usk.wroc.pl
- Contact Person Name
- Tomasz Wróbel
- Contact Person Email
- badaniakliniczne-khn@usk.wroc.pl
- Site Name
- Instytut Hematologii I Transfuzjologii
- Department Name
- Klinika Hematologii
- Principal Investigator Name
- Ewa Lech-Marańda
- Principal Investigator Email
- emaranda@ihit.waw.pl
- Contact Person Name
- Ewa Lech-Marańda
- Contact Person Email
- emaranda@ihit.waw.pl
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties code: 4
- Name
- Q Squared Solutions LLC
- Responsibilities
- sponsorDuties code: 4
- Name
- Q Squared Solutions (Beijing) Co. Ltd.
- Responsibilities
- sponsorDuties code: 4
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- sponsorDuties code: 3
- Name
- QPS Netherlands B.V.
- Responsibilities
- sponsorDuties code: 4
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- sponsorDuties code: 4
Third parties
- {"country":"United States","full_name":"FACIT.Org Inc.","duties_or_roles":"PROs ( Functional Assessment of Cancer Therapy−Lymphoma subscale [FACT-Lym LymS])","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Caerus Marketing Group LLC","duties_or_roles":"Patient Recruitment","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Crux Product Design Limited","duties_or_roles":"Site Materials, CRS Education Materials","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Q Squared Solutions (Beijing) Co. Ltd.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Axon Communications Inc.","duties_or_roles":"Patient Recruitment","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Median Technologies","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Roche Sequencing Solutions Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Swm Partners Limited","duties_or_roles":"Meeting Organizer","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"MicroCoat Biotechnologie GmbH","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"European Organisation For Research And Treatment Of Cancer","duties_or_roles":"PROs (Quality of Life); provision of EORTC Questionnaires and scoring algorithms","organisation_type":"Patient organisation/association"}
Investigational products
- Investigational Product Name
- Glofitamab
- Active Substance
- GLOFITAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Investigational / not centrally authorised (prodAuthStatus = 1)
- Investigational Product Name
- Gazyvaro (obinutuzumab)
- Active Substance
- OBINUTUZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- Intravenous
- Authorisation Status
- Marketing Authorised (prodAuthStatus = 2)
- Investigational Product Name
- MabThera (rituximab)
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- Intravenous
- Authorisation Status
- Marketing Authorised (prodAuthStatus = 2)
- Maximum Dose
- 375 mg/m2 (max daily); 3000 mg/m2 (max total)
- Investigational Product Name
- RoActemra (tocilizumab)
- Active Substance
- TOCILIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Marketing Authorised (prodAuthStatus = 2)
- Maximum Dose
- 8 mg/kg (max daily); 800 mg (max total)
- Combination Treatment
- Yes
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