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En studie för att utvärdera optimeringen av cytokinfrisättningssyndromprofilen för glofitamab i kombination med gemcitabin plus oxaliplatin hos deltagare med återfall/eldfast diffus stor B-celllymfom

6 november 2026 uppdaterad av: Hoffmann-La Roche

En fas II, öppen etikett, multicenterstudie för att utvärdera optimeringen av cytokinfrisättningssyndromprofilen för glofitamab i kombination med gemcitabin plus oxaliplatin hos patienter med återfall/förfriskande diffus stor B-celllymfom

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

130

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studera Kontakt Backup

  • Namn: 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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Obinutuzumab

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

Andra namn:
  • RO5072759
Läkemedel: 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).

Andra namn:
  • RO7082859
Läkemedel: Gemcitabine

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

Läkemedel: Oxaliplatin

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

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

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

Andra namn:
  • RO5072759
Läkemedel: 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).

Andra namn:
  • RO7082859

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Incidence of Cytokine Release Syndrome (CRS)
Tidsram: Up to approximately 5 years
Up to approximately 5 years

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

Utredare

  • Studierektor: Study Director, Hoffmann-La Roche

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 mars 2025

Primärt slutförande (Beräknad)

31 juli 2029

Avslutad studie (Beräknad)

31 juli 2030

Studieregistreringsdatum

Först inskickad

21 januari 2025

Först inskickad som uppfyllde QC-kriterierna

30 januari 2025

Första postat (Faktisk)

3 februari 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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