Phase
Condition
Hematologic Cancer
Lymphoma
Lymphoma, B-cell
Treatment
Obinutuzumab
Gemcitabine
Glofitamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed DLBCL, not otherwise specified (NOS)
R/R disease, defined as: relapsed = disease that has recurred following a responsethat 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 ofthe 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 candidatefor high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or onebi-dimensionally measurable (> 1 cm) extranodal lesion, as measured on CT scan
Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2
Adequate hematologic and renal function
Exclusion
Exclusion Criteria:
Prior enrollment in Study GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), orStudy GO44900 (NCT06624085)
Participant has failed only one prior line of therapy and is a candidate for stemcell transplantation
History of transformation of indolent disease to DLBCL
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, andhigh-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines
Primary mediastinal B-cell lymphoma
History of severe allergic or anaphylactic reactions to humanized or murinemonoclonal antibodies (or recombinant antibody-related fusion proteins) or knownsensitivity or allergy to murine products
Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab
Prior treatment with glofitamab or other bispecific antibodies targeting both CD20and CD3
Prior treatment with gemcitabine or oxaliplatin
Peripheral neuropathy or paresthesia assessed to be Grade >/= 2 according to theNational 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 weeksprior to first study treatment
Treatment with monoclonal antibodies for the purposes of treating cancer within 4weeks prior to first study treatment
Primary or secondary CNS lymphoma at the time of recruitment or history of centralnervous system (CNS) lymphoma
Prior CNS involvement that has been definitively treated and confirmed via magneticresonance imaging (MRI) or cerebrospinal fluid analysis to be in complete remissionis permissible
Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, orneurodegenerative 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 pulmonarydisease)
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episodeof infection (as evaluated by the investigator) within 4 weeks prior to the firststudy treatment
Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic activeEpstein-Barr viral infection
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) orprogressive multifocal leukoencephalopathy
Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 orbetter (with the exception of alopecia and anorexia)
Administration of a live, attenuated vaccine within 4 weeks before first studytreatment administration or anticipation that such a live, attenuated vaccine willbe 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 notlimited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumornecrosis factor agents), within 4 weeks prior to first dose of study treatment
Ongoing systemic corticosteroid use which, in the opinion of the investigator, putsthe participant at increased risk of steroid-related iatrogenic adrenalinsufficiency
Recent major surgery (within 4 weeks before the first study treatment) other thanfor diagnosis
Clinically significant history of cirrhotic liver disease
Any other diseases, metabolic dysfunction, physical examination finding, or clinicallaboratory finding giving reasonable suspicion of a disease or condition thatcontraindicates the use of an investigational drug or that may affect theinterpretation of the results or renders the participant at high-risk from treatmentcomplications
Pregnancy or breastfeeding, or intention of becoming pregnant during the study orwithin 18 months after the final dose of study treatment
Study Design
Connect with a study center
Arthur J.E. Child Comprehensive Cancer Center
Calgary, Alberta T2N 5G2
CanadaActive - Recruiting
CancerCare Manitoba
Winnipeg, Manitoba R3E 0V9
CanadaActive - Recruiting
CancerCare Manitoba (CCMB)
Winnipeg, Manitoba R3E 0V9
CanadaActive - Recruiting
CHU de Bordeaux
Pessac, 33600
FranceActive - Recruiting
Istituto Clinico Humanitas
Rozzano, Lombardia 20089
ItalyActive - Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Alaska Oncology & Hematology, LLC
Anchorage, Alaska 99508
United StatesActive - Recruiting
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesActive - Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska 68130
United StatesActive - Recruiting
New York Oncology Hematology, P.C.
Albany, New York 12206
United StatesActive - Recruiting
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