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Purpose

The main goal of this trial is to study the frequency and severity of cytokine release syndrome (CRS) in participants with relapsed or refractory (R/R) aggressive B-cell Non-Hodgkin's lymphoma (DLBCL) who are using a combination of glofitamab + gemcitabine + oxaliplatin (Glofit-GemOx) followed by glofitamab-only treatment.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

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 - 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 - 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
R/R Aggressive B-Cell Non-Hodgkin's Lymphoma 		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.
  • Drug: Obinutuzumab
    Participants will receive intravenous (IV) obinutuzumab 7 days prior to the first dose of glofitamab.
  • Drug: 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).
  • Drug: Gemcitabine
    Participants will receive IV gemcitabine in combination with glofitamab and oxaliplatin for up to 8 cycles (cycles length = 21 days).
  • Drug: Oxaliplatin
    Participants will receive IV oxaliplatin in combination with glofitamab and gemcitabine for up to 8 cycles (cycle length = 21 days).

Recruiting Locations

Alaska Oncology & Hematology, LLC
Anchorage 5879400, Alaska 5879092 99508

Providence Medical Foundation
Fullerton 5351247, California 5332921 92835

Los Angeles Cancer Network
Glendale 5352423, California 5332921 91204

Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067

Zuckerberg San Francisco General Hospital
San Francisco 5391959, California 5332921 94110

The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance 5403022, California 5332921 90502-2006

Rocky Mountain Cancer Centers, LLP
Aurora 5412347, Colorado 5417618 80012

North Florida/ South Georgia VA Medical Center
Gainesville 4156404, Florida 4155751 32608

Mount Sinai Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33140

Orlando Health Cancer Institute
Orlando 4167147, Florida 4155751 32806

St Luke?s Cancer Institute
Boise 5586437, Idaho 5596512 83712

Cancer Care Specialists of Central Illinois
Swansea 4251003, Illinois 4896861 62226

Mission Blood and Cancer - MercyOne Cancer Center
Waukee 4880981, Iowa 4862182 50263

University of Kentucky - Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536

Mary Bird Perkins Cancer Ctr
Baton Rouge 4315588, Louisiana 4331987 70809

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118

Nebraska Cancer Specialists
Omaha 5074472, Nebraska 5073708 68130

New York Oncology Hematology, P.C.
Albany 5106834, New York 5128638 12206

Hematology Oncology Associates of Central New York
East Syracuse 5116079, New York 5128638 13057

Oncology Associates of Oregon, P.C
Eugene 5725846, Oregon 5744337 97401

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213

Providence St. Vincent Medical Center
Portland 5746545, Oregon 5744337 97225

Tennessee Oncology
Chattanooga 4612862, Tennessee 4662168 37403

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203

Baylor Scott & White Health
Temple 4735966, Texas 4736286 76502

Texas Oncology - Gulf Coast
The Woodlands 4736476, Texas 4736286 77380

Texas Oncology- Northeast Texas
Tyler 4738214, Texas 4736286 75702

Virginia Cancer Specialists, PC
Fairfax 4758023, Virginia 6254928 22031

Virginia Oncology Associates - Virginia Beach
Virginia Beach 4791259, Virginia 6254928 23456

Northwest Medical Specialties
Tacoma 5812944, Washington 5815135 98405

More Details

NCT ID
NCT06806033
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: GO45434 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com

Notice

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