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En studie for å evaluere optimaliseringen av cytokinfrigjøringssyndromprofilen for glofitamab i kombinasjon med gemcitabin pluss oksaliplatin hos deltakere med tilbakefall/ildfast diffus stor B-celle lymfom

6. november 2026 oppdatert av: Hoffmann-La Roche

En fase II, åpen merkelapp, multisenterstudie for å evaluere optimaliseringen av cytokinfrigjøringssyndromprofilen for glofitamab i kombinasjon med gemcitabin pluss oksaliplatin hos pasienter med tilbakeholdt/ildfast diffus B-celle lymfom

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

130

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Obinutuzumab

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

Andre navn:
  • RO5072759
Legemiddel: 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).

Andre navn:
  • RO7082859
Legemiddel: Gemcitabine

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

Legemiddel: Oxaliplatin

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

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

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

Andre navn:
  • RO5072759
Legemiddel: 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).

Andre navn:
  • RO7082859

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of Cytokine Release Syndrome (CRS)
Tidsramme: Up to approximately 5 years
Up to approximately 5 years

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Etterforskere

  • Studieleder: Study Director, Hoffmann-La Roche

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. mars 2025

Primær fullføring (Antatt)

31. juli 2029

Studiet fullført (Antatt)

31. juli 2030

Datoer for studieregistrering

Først innsendt

21. januar 2025

Først innsendt som oppfylte QC-kriteriene

30. januar 2025

Først lagt ut (Faktiske)

3. februar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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Abonnere