A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Recruiting now · Phase 2

Conditions studied: B-Cell Non-Hodgkins Lymphoma

In brief

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) 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.

Key facts

Study ID

NCT06806033

Run by

Hoffmann-La Roche

People needed

100

Starts

2025-03-05

Expected to finish

2029-03-30

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed large B-cell lymphoma (de novo or transformed from FL) with one of the following diagnoses according to World Health Organization, fifth edition: DLBCL Not Otherwise Specified (NOS); High-Grade B-Cell Lymphoma (HGBL), NOS; DLBCL/HGBL with MYC and 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 only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
• 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
• Adequate hematologic and renal function

You may not qualify if…

• 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
• Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
• Prior treatment with gemcitabine or oxaliplatin
• Peripheral neuropathy or paresthesia assessed to be Grade >/= 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
• 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

Where it is running

• Community Cancer Institute (CCI) — Clovis, California, United States (enrolling)
• Providence Medical Foundation — Fullerton, California, United States (enrolling)
• Los Angeles Cancer Network — Glendale, California, United States (enrolling)
• Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
• Valkyrie Clinical Trials — Panorama City, California, United States (enrolling)
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States (enrolling)
• The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente — Torrance, California, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP — Aurora, Colorado, United States (enrolling)
• North Florida/ South Georgia VA Medical Center — Gainesville, Florida, United States (enrolling)
• Mount Sinai Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• Orlando Health Cancer Institute — Orlando, Florida, United States (enrolling)
• St Luke?s Cancer Institute — Boise, Idaho, United States (enrolling)
• Cancer Care Specialists of Central Illinois — Swansea, Illinois, United States (enrolling)
• Mission Blood and Cancer - MercyOne Cancer Center — Waukee, Iowa, United States (enrolling)
• University of Kentucky - Markey Cancer Center — Lexington, Kentucky, United States (enrolling)
• Mary Bird Perkins Cancer Ctr — Baton Rouge, Louisiana, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• Corewell Health — Grand Rapids, Michigan, United States (enrolling)
• Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• New York Oncology Hematology, P.C. — Albany, New York, United States (enrolling)
• Hematology Oncology Associates of Central New York — East Syracuse, New York, United States (enrolling)
• Oncology Associates of Oregon, P.C — Eugene, Oregon, United States (enrolling)
• Providence Portland Medical Center — Portland, Oregon, United States (enrolling)
• Providence St. Vincent Medical Center — Portland, Oregon, United States (enrolling)
• Alaska Oncology & Hematology, LLC — Anchorage, Alaska, United States (enrolling)

Full record on ClinicalTrials.gov

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