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Een studie om de optimalisatie van het cytokine-afgifte-syndroomprofiel voor glofitamab te evalueren in combinatie met gemcitabine plus oxaliplatine bij deelnemers met recidivert/refractair diffuse grote B-cellymfoom

6 november 2026 bijgewerkt door: Hoffmann-La Roche

Een fase II, open-label, multicenter-studie om de optimalisatie van het cytokine-afgifte-syndroomprofiel voor glofitamab te evalueren in combinatie met gemcitabine plus oxaliplatine bij patiënten met relapsed/vuurvast diffuse grote B-cel lymfoom

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) followed by glofitamab monotherapy treatment regimen (Cohort A), and for glofitamab monotherapy (Cohort B) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

130

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Studie Contact Back-up

  • Naam: Reference Study ID Number: GO45434 https://forpatients.roche.com/ No attachments to email below.
  • Telefoonnummer: 888-662-6728 (U.S. Only)
  • E-mail: global-roche-genentech-trials@gene.com

Studie Locaties

  • Australië
    • Victoria
      • East Melbourne, Victoria, Australië, 3002
        • Werving
        • Epworth Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Werving
        • Arthur J.E. Child Comprehensive Cancer Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Werving
        • CancerCare Manitoba (CCMB)
  • Duitsland
      • Berlin, Duitsland, 12200
        • Ingetrokken
        • CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
      • Berlin, Duitsland, 13353
        • Ingetrokken
        • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
      • Cologne, Duitsland, 50937
        • Werving
        • Universitätsklinikum Köln
      • Magdeburg, Duitsland, 39120
        • Werving
        • Otto von Guericke Uni Magdeburg Uniklinik
  • Frankrijk
      • La Tronche, Frankrijk, 38700
        • Werving
        • CHU de Grenoble
      • Montpellier, Frankrijk, 34295
        • Werving
        • Chu de Montpellier-St Eloi
      • Pessac, Frankrijk, 33600
        • Werving
        • CHU de Bordeaux
      • Rennes, Frankrijk, 35033
        • Ingetrokken
        • CHU DE RENNES - CHU Pontchaillou
      • Tours, Frankrijk, 37000
        • Werving
        • Chu De Tours
  • Italië
    • Campania
      • Naples, Campania, Italië, 80131
        • Werving
        • Istituto Nazionale Tumori Irccs Fondazione g. Pascale
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italië, 47014
        • Werving
        • IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
    • Lombardy
      • Brescia, Lombardy, Italië, 25123
        • Werving
        • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
      • Milan, Lombardy, Italië, 20141
        • Werving
        • Irccs Istituto Europeo Di Oncologia (IEO)
      • Rozzano, Lombardy, Italië, 20089
        • Werving
        • Istituto Clinico Humanitas
  • Verenigde Staten
    • Alaska
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Werving
        • Alaska Oncology & Hematology, LLC
    • California
      • Clovis, California, Verenigde Staten, 93611
        • Werving
        • Community Cancer Institute (CCI)
      • Fullerton, California, Verenigde Staten, 92835
        • Werving
        • Providence Medical Foundation
      • Glendale, California, Verenigde Staten, 91204
        • Ingetrokken
        • Los Angeles Cancer Network
      • Los Angeles, California, Verenigde Staten, 90067
        • Werving
        • Valkyrie Clinical Trials
      • Panorama City, California, Verenigde Staten, 91402
        • Werving
        • Valkyrie Clinical Trials
      • San Francisco, California, Verenigde Staten, 94110
        • Werving
        • Zuckerberg San Francisco General Hospital
      • Torrance, California, Verenigde Staten, 90502-2006
        • Werving
        • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80012
        • Werving
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Gainesville, Florida, Verenigde Staten, 32608
        • Ingetrokken
        • North Florida/ South Georgia VA Medical Center
      • Miami, Florida, Verenigde Staten, 33140
        • Werving
        • Mount Sinai Comprehensive Cancer Center
      • Orlando, Florida, Verenigde Staten, 32806
        • Werving
        • Orlando Health Cancer Institute
    • Idaho
      • Boise, Idaho, Verenigde Staten, 83712
        • Werving
        • St Luke?s Cancer Institute
    • Illinois
      • Swansea, Illinois, Verenigde Staten, 62226
        • Werving
        • Cancer Care Specialists of Central Illinois
    • Iowa
      • Waukee, Iowa, Verenigde Staten, 50263
        • Werving
        • Mission Blood and Cancer - MercyOne Cancer Center
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40536
        • Werving
        • University of Kentucky - Markey Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, Verenigde Staten, 70809
        • Werving
        • Mary Bird Perkins Cancer Ctr
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02118
        • Werving
        • Boston Medical Center
    • Michigan
      • Grand Rapids, Michigan, Verenigde Staten, 49503
        • Werving
        • Corewell Health
    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68130
        • Werving
        • Nebraska Cancer Specialists
    • New York
      • Albany, New York, Verenigde Staten, 12206
        • Werving
        • New York Oncology Hematology, P.C.
      • East Syracuse, New York, Verenigde Staten, 13057
        • Werving
        • Hematology Oncology Associates of Central New York
    • Oregon
      • Eugene, Oregon, Verenigde Staten, 97401
        • Werving
        • Oncology Associates of Oregon, P.C
      • Portland, Oregon, Verenigde Staten, 97213
        • Werving
        • Providence Portland Medical Center
      • Portland, Oregon, Verenigde Staten, 97225
        • Werving
        • Providence St. Vincent Medical Center
    • Tennessee
      • Chattanooga, Tennessee, Verenigde Staten, 37403
        • Werving
        • Tennessee Oncology
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Werving
        • Tennessee Oncology
    • Texas
      • Temple, Texas, Verenigde Staten, 76502
        • Werving
        • Baylor Scott & White Health
      • The Woodlands, Texas, Verenigde Staten, 77380
        • Werving
        • Texas Oncology - Gulf Coast
      • Tyler, Texas, Verenigde Staten, 75702
        • Werving
        • Texas Oncology- Northeast Texas
    • Virginia
      • Fairfax, Virginia, Verenigde Staten, 22031
        • Werving
        • Virginia Cancer Specialists, PC
      • Virginia Beach, Virginia, Verenigde Staten, 23456
        • Werving
        • Virginia Oncology Associates - Virginia Beach
    • Washington
      • Tacoma, Washington, Verenigde Staten, 98405
        • Werving
        • Northwest Medical Specialties
  • Zuid -Korea
      • Seongnam-si, Zuid -Korea, 463-707
        • Actief, niet wervend
        • Seoul National University Bundang Hospital
      • Seoul, Zuid -Korea, 03080
        • Ingetrokken
        • Seoul National University Hospital
      • Seoul, Zuid -Korea, 05505
        • Actief, niet wervend
        • Asan Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Life expectancy >= 12 weeks.

  • For participants in the Glofit-GemOx combination therapy cohort (Cohort A) and the glofitamab monotherapy cohort (Cohort B), participant with histologically confirmed diffuse large B-cell lymphoma, (de novo or transformed from a follicular lymphoma (FL); participants with transformed FL must be relapsed or refractory (R/R) to standard therapies of transformed FL) with one of the following diagnoses according to World Health Organization, fifth edition (Alaggio et al. 2022). A fresh biopsy at study entry is not mandated. The histology can be confirmed based on fresh biopsy, or pathology report from a previous biopsy or an assessment of archival tumor tissue.

    1. Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified (NOS).
    2. High-Grade B-Cell Lymphoma (HGBL), NOS.
    3. DLBCL/HGBL with myelocytomatosis proto-oncogene (MYC) and B-cell lymphoma 2 (BCL2) rearrangements.

  • R/R disease, defined as: relapsed = disease that has recurred following a response that lasted >/= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed < 6 months after completion of the last line of therapy.

  • At least one line of prior systemic therapy.

  • Participants who have failed one prior line of therapy (eligible to Cohort A) must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant.

  • 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.

  • Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2.

  • According to the investigator's judgment, participants should be able to receive the step-up dose regimen in an outpatient setting.

Exclusion Criteria:

  • Prior enrollment in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085).
  • Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation.
  • Any history of Waldenstrom's macroglobulinemia.
  • Primary mediastinal B-cell lymphoma.
  • 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.
  • Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab. For participants in the monotherapy cohort (Cohort B), participants with contraindication to obinutuzumab or tocilizumab will be excluded.
  • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.
  • For the Glofit-GemOx combination therapy cohort (Cohort A), prior treatment with gemcitabine or oxaliplatin.
  • For the Glofit-GemOx combination therapy cohort (Cohort A), peripheral neuropathy or paresthesia assessed to be Grade >= 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrolment.
  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment.
  • Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment.
  • Primary or secondary CNS lymphoma at the time of recruitment.
  • Prior CNS involvement that has been definitively treated and confirmed via magnetic resonance imaging (MRI) or cerebrospinal fluid analysis to be in complete remission is permissible.
  • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
  • History of other primary malignancy, with exceptions defined by the protocol.
  • Significant or extensive cardiovascular disease.
  • Significant pulmonary disease (including moderate or severe obstructive pulmonary disease).
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment.
  • Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic active Epstein-Barr viral infection.
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) or progressive multifocal leukoencephalopathy.
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia).
  • Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study.
  • Prior solid organ transplantation or prior allogenic stem cell transplant.
  • Active autoimmune disease requiring treatment.
  • Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents), within 4 weeks prior to first dose of study treatment.
  • Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the participant at increased risk of steroid-related iatrogenic adrenal insufficiency.
  • Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis.
  • Clinically significant history of cirrhotic liver disease.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high-risk from treatment complications.
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after the final dose of study treatment.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cohort A: Glofit-GemOx Combination therapy

Participants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, followed by glofitamab + gemcitabine + oxaliplatin, followed by glofitamab monotherapy.

NOTE: Cohort A has been closed for recruitment.
Geneesmiddel: Obinutuzumab

Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.

Andere namen:
  • RO5072759
Geneesmiddel: Glofitamab

Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).

Andere namen:
  • RO7082859
Geneesmiddel: Gemcitabine

Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).

Geneesmiddel: Oxaliplatin

Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).
Experimenteel: Cohort B: Glofitamab Monotherapy

Participants with R/R aggressive B-cell Non-Hodgkin's Lymphoma will receive obinutuzumab pre-treatment, followed by glofitamab monotherapy.
Geneesmiddel: Obinutuzumab

Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.

Andere namen:
  • RO5072759
Geneesmiddel: Glofitamab

Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).

Andere namen:
  • RO7082859

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Incidence of Cytokine Release Syndrome (CRS)
Tijdsspanne: Up to approximately 5 years
Up to approximately 5 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Serious Cytokine Release Syndrome (CRS) Events
Tijdsspanne: Up to approximately 5 years
Up to approximately 5 years
CRS Frequency Relative to the Start of Glofitamab Infusions
Tijdsspanne: Up to approximately 5 years
Up to approximately 5 years
Incidence and Severity of Adverse Events (AEs)
Tijdsspanne: Up to approximately 5 years
Up to approximately 5 years
Complete Response (CR) Rate as Determined by Independent Review Facility (IRF) and the Investigator
Tijdsspanne: Up to approximately 5 years

CR rate is defined as the proportion of participants whose best overall response is a CR based on PET/CT according to the 2014 Lugano Response Criteria during the study, as determined by the Independent Review Facility and the investigator.
Up to approximately 5 years
Overall Response Rate (ORR) as Determined by IRF and the Investigator
Tijdsspanne: Up to approximately 5 years

ORR is defined as the proportion of participants whose best overall response is a PR or a CR according to the 2014 Lugano Response Criteria during the study, as determined by the Independent Review Facility and the investigator.
Up to approximately 5 years
Duration of Response (DOR)
Tijdsspanne: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)

DOR is defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, or death from any cause, whichever occurs first.
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Duration of Complete Response (DOCR)
Tijdsspanne: From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)

DOCR is defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first.
From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Progression-Free Survival (PFS) as Determined by the IRF and the Investigator
Tijdsspanne: From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)

PFS is defined as the time from enrollment to the first occurrence of disease progression according to the 2014 Lugano Response Criteria or death from any cause, whichever occurs first, as determined by the Independent Review Facility and investigator.
From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (Up to approximately 5 years)
Overall Survival (OS)
Tijdsspanne: From enrollment to date of death from any cause (Up to approximately 5 years)

OS is defined as the time from enrollment to date of death from any cause.
From enrollment to date of death from any cause (Up to approximately 5 years)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Onderzoekers

  • Studie directeur: Study Director, Hoffmann-La Roche

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 maart 2025

Primaire voltooiing (Geschat)

31 juli 2029

Studie voltooiing (Geschat)

31 juli 2030

Studieregistratiedata

Eerst ingediend

21 januari 2025

Eerst ingediend dat voldeed aan de QC-criteria

30 januari 2025

Eerst geplaatst (Werkelijk)

3 februari 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GO45434
  • 2024-516791-15-00 (Ctis)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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