Clinical trial • Phase II • Oncology
Glofitamab for Aggressive B-cell non-Hodgkin lymphoma (relapsed/refractory) | Diffuse large B-cell lymphoma (DLBCL) (relapsed/refractory) | High-grade B-cell lymphoma (relapsed/refractory)
Phase II trial of Glofitamab for Aggressive B-cell non-Hodgkin lymphoma (relapsed/refractory) | Diffuse large B-cell lymphoma (DLBCL) (relapsed/refractory…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Aggressive B-cell non-Hodgkin lymphoma (relapsed/refractory) | Diffuse large B-cell lymphoma (DLBCL) (relapsed/refractory) | High-grade B-cell lymphoma (relapsed/refractory)
- Trial Stage
- Phase II
- Drug Modality
- Bispecific antibody | Monoclonal antibody | Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 18-11-2024
- First CTIS Authorization Date
- 19-03-2025
Trial design
open-label Phase II trial across 14 sites in Italy, France, Germany.
- Open Label
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 74
Eligibility
Recruits 74 paediatric patients.
- Vulnerable Population
- Vulnerable populations are selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms for infants/children and pregnant partners are listed among the submitted documents (examples: 'L1_SIS and ICF infant and Privacy sheet', 'L1_SIS and ICF enfant', 'L1_SIS and ICF_PregPatient_GO45434', 'L1_SIS and ICF_PregPartner_GO45434', and country-specific ICFs). Specific consent/assent handling text and procedures are not provided in the JSON.
Inclusion criteria
- {"criterion_text":"- Life expectancy ≥ 12 weeks"}
- {"criterion_text":"- Participant with histologically confirmed diffuse large B-cell lymphoma, (de novo or transformed from a follicular lymphoma) with one of the following diagnoses according to World Health Organization, fifth edition (Alaggio et al. 2022):-DLBCL not otherwise specified (NOS) - High-Grade B-Cell Lymphoma (HGBL), NOS; – DLBCL/HGBL with myelocytomatosis proto-oncogene (MYC) and B-cell lymphoma 2 (BCL2) rearrangements"}
- {"criterion_text":"- Relapsed / refractory disease"}
- {"criterion_text":"- At least one prior line of systemic therapy - Participants may have undergone ASCT prior to recruitment - Local therapies (e.g., radiotherapy) will not be considered as lines of therapy"}
- {"criterion_text":"- Participants who have failed one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant"}
- {"criterion_text":"- At least one bi-dimensionally measurable ( > 1.5 cm) nodal lesion, or one bi-dimensionally measurable ( > 1 cm) extranodal lesion, as measured on CT scan"}
Exclusion criteria
- {"criterion_text":"- Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation"}
- {"criterion_text":"- Any history of Waldenström’s macroglobulinemia"}
- {"criterion_text":"- Primary mediastinal B-cell lymphoma"}
- {"criterion_text":"- Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab"}
- {"criterion_text":"- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Incidence of CRS: Grade 2 or higher CRS at any time during the study, determined according to the ASTCT CRS grading criteria","definition_or_measurement_approach":"Determined according to the ASTCT CRS grading criteria"}
- {"endpoint_text":"- 2. Incidence of CRS: Any Grade CRS, at any time during the study","definition_or_measurement_approach":"Any grade CRS occurring at any time during the study (no additional measurement approach specified beyond incidence capture)"}
Secondary endpoints
- {"endpoint_text":"- 1. Incidence of serious CRS events, with severity determined according to the ASTCT CRS grading criteria","definition_or_measurement_approach":"Severity determined according to ASTCT CRS grading criteria"}
- {"endpoint_text":"- 2. CRS frequency relative to the start of the infusion of each of the step-up doses of glofitamab","definition_or_measurement_approach":"Frequency measured relative to infusion start time of each step-up dose of glofitamab"}
- {"endpoint_text":"- 3. CRS management, including outcome of patients who experienced a CRS event","definition_or_measurement_approach":"Assess management actions and outcomes in patients with CRS events (no further detail provided)"}
- {"endpoint_text":"- 4. Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 , except CRS, ICANS, and HLH that will be graded using ASTCT grading criteria (Lee et al. 2019; Hines et al. 2023)","definition_or_measurement_approach":"AE severity by NCI CTCAE v5.0; CRS/ICANS/HLH graded per ASTCT criteria"}
- {"endpoint_text":"- 5. Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity","definition_or_measurement_approach":"Tolerability assessed via dose interruptions, dose reductions and dose intensity metrics"}
- {"endpoint_text":"- 6. Study treatment discontinuation because of adverse events","definition_or_measurement_approach":"Count/record discontinuations due to AEs"}
- {"endpoint_text":"- 7. Complete response (CR) rate","definition_or_measurement_approach":"CR rate as per study response assessment (specific response criteria not detailed in JSON)"}
- {"endpoint_text":"- 8. Objective response rate (ORR)","definition_or_measurement_approach":"ORR as per study response assessment (specific criteria not provided)"}
- {"endpoint_text":"- 9. Duration of response (DOR)","definition_or_measurement_approach":"DOR measured from response until progression (specific date rules not provided)"}
- {"endpoint_text":"- 10. Duration of complete response (DOCR)","definition_or_measurement_approach":"Duration of complete response measured from CR until relapse/progression"}
- {"endpoint_text":"- 11. Progression-free survival (PFS)","definition_or_measurement_approach":"PFS measured per study definitions (not specified in JSON)"}
- {"endpoint_text":"- 12. Overall survival (OS)","definition_or_measurement_approach":"OS measured from date of randomization/enrollment to death (specifics not provided)"}
Recruitment
- Registry Or Advocacy Recruitment
- True, Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi (listed as patient organisation/association)
- Planned Sample Size
- 74
- Recruitment Window Months
- 48
- Consent Approach
- Subject information and informed consent forms are submitted and include versions for main subjects, infant/child, pregnant patient and pregnant partner (documents include e.g., 'L1_SIS and ICF Main_GO45434_redacted', 'L1_SIS and ICF infant and Privacy sheet', 'L1_SIS and ICF_PregPatient_GO45434', 'L1_SIS and ICF_PregPartner_GO45434'). Country-specific documents are present for member states (France, Italy, Germany) and protocol translations exist (English, French, German, Italian). Specific procedural text on who provides consent/assent and language availability beyond the document listings is not provided in the JSON.
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 26
Italy
- Earliest CTIS Part Ii Submission Date
- 25-07-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 626
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- U.O. di Oncologia Medica ed Ematologia
- Contact Person Name
- Carmelo Carlo-Stella
- Contact Person Email
- carmelo.carlostella@hunimed.eu
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione di Oncoematologia
- Contact Person Name
- Enrico Derenzini
- Contact Person Email
- Enrico.Derenzini@ieo.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- U.O. Ematologia
- Contact Person Name
- Alessandra Tucci
- Contact Person Email
- alessandra.tucci@asst-spedalicivili.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- S.C. Ematologia Oncologica
- Contact Person Name
- Antonio Pinto
- Contact Person Email
- a.pinto@istitutotumori.na.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Ematologia
- Contact Person Name
- Gerardo Musuraca
- Contact Person Email
- gerardo.musuraca@irst.emr.it
France
- Earliest CTIS Part Ii Submission Date
- 20-12-2024
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 484
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hematology
- Contact Person Name
- Charles Herbaux
- Contact Person Email
- c-herbaux@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Hematology
- Contact Person Name
- Roch Houot
- Contact Person Email
- Roch.HOUOT@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hematology
- Contact Person Name
- François-Xavier Gros
- Contact Person Email
- francois-xavier.gros@chu-bordeaux.mssante.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Hematology
- Contact Person Name
- Lucile Bussot
- Contact Person Email
- lbussot@chu-grenoble.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Hematology
- Contact Person Name
- Emmanuel GYAN
- Contact Person Email
- e.gyan@chu-tours.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 17-02-2025
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 420
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Department Name
- Hämatology
- Contact Person Name
- Vanja Zeremski
- Contact Person Email
- vanja.zeremski@med.ovgu.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Hämatologie
- Contact Person Name
- Björn Chapuy
- Contact Person Email
- bjoern.chapuy@charite.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Hämatologie
- Contact Person Name
- Björn Chapuy
- Contact Person Email
- bjoern.chapuy@charite.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Hämatology
- Contact Person Name
- Peter Borchmann
- Contact Person Email
- peter.borchmann@uk-koeln.de
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Third parties
- {"country":"United States","full_name":"FACIT.Org Inc.","duties_or_roles":"Clinical Outcome Assessment (eCOA, ePRO) Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement Provider","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi","duties_or_roles":"Clinical Outcome","organisation_type":"Patient organisation/association"}
- {"country":"France","full_name":"Median Technologies","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"IxRS Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Laboratory Provider","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Glofitamab
- Active Substance
- Glofitamab
- Modality
- Bispecific antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation available (marketingAuthNumber EU/1/23/1742/002)
- Investigational Product Name
- Gemcitabine
- Active Substance
- Gemcitabine
- Modality
- Small molecule
- Authorisation Status
- Marketing authorisation available (marketingAuthNumber HR-H-808889278 / other MA numbers listed)
- Investigational Product Name
- Oxaliplatin
- Active Substance
- Oxaliplatin
- Modality
- Small molecule
- Authorisation Status
- Marketing authorisation available (multiple marketing author numbers listed)
- Investigational Product Name
- Obinutuzumab
- Active Substance
- Obinutuzumab
- Modality
- Monoclonal antibody
- Authorisation Status
- Marketing authorisation available (marketingAuthNumber EU/1/14/937/001)
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)