Phase
Condition
Hematologic Cancer
Lymphoma, B-cell
Lymphoma
Treatment
Obinutuzumab
Gemcitabine
Glofitamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed large B-cell lymphoma (de novo or transformed from FL) withone of the following diagnoses according to World Health Organization, fifthedition: 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 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
According to the investigator's judgment, participants should be able to receive thestep-up dose regimen in an outpatient setting
Adequate hematologic and renal function
Exclusion
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 stemcell transplantation
Any history of Waldenstrom's macroglobulinemia
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
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
Epworth Hospital
East Melbourne, Victoria 3002
AustraliaActive - Recruiting
Epworth Hospital
East Melbourne 6952201, Victoria 2145234 3002
AustraliaSite Not Available
Arthur J.E. Child Comprehensive Cancer Center
Calgary, Alberta T2N 5G2
CanadaActive - Recruiting
Arthur J.E. Child Comprehensive Cancer Center
Calgary 5913490, Alberta 5883102 T2N 5G2
CanadaSite Not Available
CancerCare Manitoba
Winnipeg, Manitoba R3E 0V9
CanadaActive - Recruiting
CancerCare Manitoba (CCMB)
Winnipeg, Manitoba R3E 0V9
CanadaActive - Recruiting
CancerCare Manitoba (CCMB)
Winnipeg 6183235, Manitoba 6065171 R3E 0V9
CanadaSite Not Available
CHU de Grenoble
La Tronche, 38700
FranceActive - Recruiting
CHU de Grenoble
La Tronche 3006131, 38700
FranceSite Not Available
Chu de Montpellier-St Eloi
Montpellier, 34295
FranceActive - Recruiting
Chu de Montpellier-St Eloi
Montpellier 2992166, 34295
FranceSite Not Available
CHU de Bordeaux
Pessac, 33600
FranceActive - Recruiting
CHU de Bordeaux
Pessac 2987805, 33600
FranceSite Not Available
CHU DE RENNES - CHU Pontchaillou
Rennes, 35033
FranceActive - Recruiting
CHU DE RENNES - CHU Pontchaillou
Rennes 2983990, 35033
FranceSite Not Available
Chu De Tours
Tours, 37000
FranceActive - Recruiting
Chu De Tours
Tours 2972191, 37000
FranceSite Not Available
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
Berlin, 12200
GermanyActive - Recruiting
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, 13353
GermanyActive - Recruiting
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
Berlin 2950159, 12200
GermanyActive - Recruiting
Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin 2950159, 13353
GermanySite Not Available
Universitätsklinikum Köln
Cologne, 50937
GermanyActive - Recruiting
Universitätsklinikum Köln
Cologne 2886242, 50937
GermanySite Not Available
Otto von Guericke Uni Magdeburg Uniklinik
Magdeburg, 39120
GermanyActive - Recruiting
Otto von Guericke Uni Magdeburg Uniklinik
Magdeburg 2874545, 39120
GermanySite Not Available
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Naples, Campania 80131
ItalyActive - Recruiting
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Napoli, Campania 80131
ItalySite Not Available
Istituto Nazionale Tumori Irccs Fondazione g. Pascale
Napoli 9031661, Campania 3181042 80131
ItalySite Not Available
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, Emilia-Romagna 47014
ItalyActive - Recruiting
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola 3173635, Emilia-Romagna 3177401 47014
ItalySite Not Available
Irccs Istituto Europeo Di Oncologia (IEO)
Milano, Lombardia 20141
ItalySite Not Available
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy 25123
ItalyActive - Recruiting
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy 20141
ItalyActive - Recruiting
Istituto Clinico Humanitas
Rozzano, Lombardy 20089
ItalyActive - Recruiting
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia 3181554, Lombardy 3174618 25123
ItalySite Not Available
Irccs Istituto Europeo Di Oncologia (IEO)
Milan 3173435, Lombardy 3174618 20141
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano 3168837, Lombardy 3174618 20089
ItalySite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 463-707
South KoreaActive - Recruiting
Seoul National University Bundang Hospital
Seongnam-si 1897000, 463-707
South KoreaSite Not Available
Asan Medical Center
Seoul, 05505
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, 03080
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaSite Not Available
Alaska Oncology & Hematology, LLC
Anchorage, Alaska 99508
United StatesActive - Recruiting
Alaska Oncology & Hematology, LLC
Anchorage 5879400, Alaska 5879092 99508
United StatesSite Not Available
Community Cancer Institute (CCI)
Clovis, California 93611
United StatesActive - Recruiting
Providence Medical Foundation
Fullerton, California 92835
United StatesActive - Recruiting
Los Angeles Cancer Network
Glendale, California 91204
United StatesActive - Recruiting
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesActive - Recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California 94110
United StatesActive - Recruiting
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance, California 90502-2006
United StatesActive - Recruiting
Community Cancer Institute (CCI)
Clovis 5338122, California 5332921 93611
United StatesSite Not Available
Providence Medical Foundation
Fullerton 5351247, California 5332921 92835
United StatesSite Not Available
Los Angeles Cancer Network
Glendale 5352423, California 5332921 91204
United StatesSite Not Available
Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067
United StatesSite Not Available
Zuckerberg San Francisco General Hospital
San Francisco 5391959, California 5332921 94110
United StatesSite Not Available
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance 5403022, California 5332921 90502-2006
United StatesSite Not Available
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado 80012
United StatesActive - Recruiting
Rocky Mountain Cancer Centers, LLP
Aurora 5412347, Colorado 5417618 80012
United StatesSite Not Available
North Florida/ South Georgia VA Medical Center
Gainesville, Florida 32608
United StatesActive - Recruiting
Mount Sinai Comprehensive Cancer Center
Miami, Florida 33140
United StatesActive - Recruiting
Orlando Health Cancer Institute
Orlando, Florida 32806
United StatesActive - Recruiting
North Florida/ South Georgia VA Medical Center
Gainesville 4156404, Florida 4155751 32608
United StatesSite Not Available
Mount Sinai Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33140
United StatesSite Not Available
Orlando Health Cancer Institute
Orlando 4167147, Florida 4155751 32806
United StatesSite Not Available
St Luke?s Cancer Institute
Boise, Idaho 83712
United StatesActive - Recruiting
St Luke?s Cancer Institute
Boise 5586437, Idaho 5596512 83712
United StatesSite Not Available
Cancer Care Specialists of Central Illinois
Swansea, Illinois 62226
United StatesActive - Recruiting
Cancer Care Specialists of Central Illinois
Swansea 4251003, Illinois 4896861 62226
United StatesSite Not Available
Mission Blood and Cancer - MercyOne Cancer Center
Waukee, Iowa 50263
United StatesActive - Recruiting
Mission Blood and Cancer - MercyOne Cancer Center
Waukee 4880981, Iowa 4862182 50263
United StatesSite Not Available
University of Kentucky - Markey Cancer Center
Lexington, Kentucky 40536
United StatesActive - Recruiting
University of Kentucky - Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536
United StatesSite Not Available
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana 70809
United StatesActive - Recruiting
Mary Bird Perkins Cancer Ctr
Baton Rouge 4315588, Louisiana 4331987 70809
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesActive - Recruiting
Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
United StatesSite Not Available
Nebraska Cancer Specialists
Omaha, Nebraska 68130
United StatesActive - Recruiting
Nebraska Cancer Specialists
Omaha 5074472, Nebraska 5073708 68130
United StatesSite Not Available
New York Oncology Hematology, P.C.
Albany, New York 12206
United StatesActive - Recruiting
Hematology Oncology Associates of Central New York
East Syracuse, New York 13057
United StatesActive - Recruiting
New York Oncology Hematology, P.C.
Albany 5106834, New York 5128638 12206
United StatesSite Not Available
Hematology Oncology Associates of Central New York
East Syracuse 5116079, New York 5128638 13057
United StatesSite Not Available
Oncology Associates of Oregon, P.C
Eugene, Oregon 97401
United StatesActive - Recruiting
Providence Portland Medical Center
Portland, Oregon 97213
United StatesActive - Recruiting
Providence St. Vincent Medical Center
Portland, Oregon 97225
United StatesActive - Recruiting
Oncology Associates of Oregon, P.C
Eugene 5725846, Oregon 5744337 97401
United StatesSite Not Available
Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213
United StatesActive - Recruiting
Providence St. Vincent Medical Center
Portland 5746545, Oregon 5744337 97225
United StatesSite Not Available
Tennessee Oncology
Chattanooga, Tennessee 37403
United StatesActive - Recruiting
Tennessee Oncology
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Oncology
Chattanooga 4612862, Tennessee 4662168 37403
United StatesSite Not Available
Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Baylor Scott & White Health
Temple, Texas 76502
United StatesActive - Recruiting
Texas Oncology - Gulf Coast
The Woodlands, Texas 77380
United StatesActive - Recruiting
Texas Oncology- Northeast Texas
Tyler, Texas 75702
United StatesActive - Recruiting
Baylor Scott & White Health
Temple 4735966, Texas 4736286 76502
United StatesSite Not Available
Texas Oncology - Gulf Coast
The Woodlands 4736476, Texas 4736286 77380
United StatesSite Not Available
Texas Oncology- Northeast Texas
Tyler 4738214, Texas 4736286 75702
United StatesSite Not Available
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesActive - Recruiting
Virginia Cancer Specialists, PC
Gainesville, Virginia 20155
United StatesSite Not Available
Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia 23456
United StatesActive - Recruiting
Virginia Cancer Specialists, PC
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available
Virginia Cancer Specialists, PC
Gainesville 4760363, Virginia 6254928 20155
United StatesSite Not Available
Virginia Oncology Associates - Virginia Beach
Virginia Beach 4791259, Virginia 6254928 23456
United StatesSite Not Available
Northwest Medical Specialties
Tacoma, Washington 98405
United StatesActive - Recruiting
Northwest Medical Specialties
Tacoma 5812944, Washington 5815135 98405
United StatesSite Not Available

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