[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aggressive-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aggressive-non-hodgkin-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100380306","phase-1-polatuzumab-vedotin-and-combination-chemotherapy-with-or-without-glofitamab-for-the-treatment-of-untreated-aggressive-large-b-cell-lymphoma-100380306",false,"NCT04231877","Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma","A Pilot Study to Estimate the Safety and Tolerability of the Combination of Polatuzumab Vedotin, With or Without Glofitamab, With Dose Adjusted Rituximab, Etoposide, Cyclophosphamide, and Doxorubicin (PERCH) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas","Inclusion Criteria:\n\n* Untreated aggressive B-cell large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to rituximab-cyclophosphamide, doxorubicin (hydroxydaunorubicin), vincristine (Oncovin), prednisone (R-CHOP) and in the opinion of the investigator would be treated with DA-EPOCH-R as standard of care. Subjects must be planned to receive full course (6 cycles) chemoimmunotherapy as per clinical standard of care. Composite lymphomas are not excluded provided that the subject has not receive prior systemic therapy for the indolent component and would receive DA-EPOCH-R as the standard of care regimen for the aggressive component. Eligible histologies based on 2016 World Health Organization (WHO) classification include:\n\n  * High grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 translocations\n  * High grade B-cell lymphoma, not otherwise specified (NOS)\n  * Diffuse large B-cell lymphoma (DLBCL) NOS\n  * Primary mediastinal B-cell lymphoma\n  * T-cell\u002Fhistiocyte-rich large-B-cell lymphoma\n  * Epstein-Barr virus (EBV) + DLBCL, NOS\n  * ALK+ large B-cell lymphoma (must be CD20+)\n  * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n* Be willing and able to provide written informed consent for the trial\n* Be \\>= 18 years of age on day of signing informed consent\n* Have measurable disease, including at least 1 nodal site measuring 1.5 cm or 1 extranodal site measuring 1.0 cm in longest dimension on computed tomography (CT) or fluorodeoxyglucose-positron emission tomography (FDG-PET)\n* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS)\n* Left ventricular ejection fraction (LVEF) \\>= 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)\n* Absolute neutrophil count (ANC) \\>= 1,000\u002FuL except in cases of marrow infiltration by lymphoma\n* Platelets \\>= 75,000 \u002F mcL except in cases of marrow infiltration by lymphoma or hypersplenism\n* Hemoglobin \\>= 8 g\u002FdL except in cases of marrow infiltration by lymphoma without red blood cell (RBC) transfusion within 14 days of first treatment\n* Measured or calculated creatinine clearance (Glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) \\>= 40 mL\u002Fmin.\n\n  \\* Creatinine clearance should be calculated per institutional standard\n* Serum total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) (Patients with documented Gilbert disease may be enrolled if total bilirubin =\\\u003C 3.0 x ULN)\n* Direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for subjects with liver involvement\n* International Normalized Ratio (INR) or Prothrombin Time (PT) =\\\u003C 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, or subject is shown to have an antiphospholipid antibody on workup\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of =\\\u003C 1% per year during the treatment period and for at least 12 months after the last dose of EPCH-R, 9 months after the last dose of polatuzumab, 2 months after the last dose of glofitamab (Arm B participants), or 3 months after the last dose of tocilizumab (if applicable), whichever is longer. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (=\\\u003C12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of contraceptive methods with a failure rate of =\\\u003C1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* For women of childbearing potential, a negative serum pregnancy test result during screening period. Women who are considered not to be of childbearing potential are not required to have a pregnancy test\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of EPCH-R or polatuzumab, 2 months after the last dose of glofitamab (Arm B participants), or 2 months after the last dose of tocilizumab (if applicable), whichever is longer. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of preventing drug exposure. Male patients considering preservation of fertility should bank sperm before study treatment\n* ARM B ONLY: Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment\n\nExclusion Criteria:\n\n* Contraindication to any of the individual components of glofitamab, tocilizumab or EPCH-R, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products\n* Prior systemic treatment for lymphoma with the exception of corticosteroids. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response.\n* Richter's transformation from chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma is not allowed. Transformation from follicular or other indolent lymphomas is allowed provided that the subject has not received prior systemic therapy for their lymphoma and the aggressive component meets one of the criteria listed in inclusion criterion 1\n* Diagnosis of Burkitt lymphoma\n* Prior organ transplantation\n* Current Grade \\> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease\n* Prior systemic therapy for indolent lymphoma\n* Prior use of any monoclonal antibody within 3 months of the start of cycle 1; any investigational therapy within 28 days prior to the start of cycle 1; vaccination with live vaccines within 28 days prior the start of cycle 1 and at any time during the study treatment period\n* Prior therapy for large B-cell lymphoma except for patients who require lymphoma symptom control during screening may receive steroids in the following manner: Up to 30 mg\u002Fday of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment) If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of \\> 30-100 mg\u002Fday of prednisone or equivalent. Prednisone \\> 30-100 mg\u002Fday or equivalent may be given for a maximum of 7 days as a pre-phase treatment. If patients exceed the allowed dosing of corticosteroids, patients may still be eligible for the study provided that baseline imaging is performed (or repeated) after completion of the course of higher dose of steroids. Allowed corticosteroid dosing resets from the point of imaging forward and patients who do not exceed the allowed corticosteroid dosing from the point of imaging until initiation of study treatment may enroll\n* History of other malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver:\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible\n  * Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for \\>= 2 years prior to enrollment are eligible\n  * Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible\n* Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Recent major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis\n* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for infection, but systemic treatment must be completed by cycle 1 day 1\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology):\n\n  \\* Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standard\n* Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing)\n\n  \\* Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\n* History of uncontrolled human immunodeficiency virus (HIV)\n\n  \\* Patients with known diagnosis of HIV must have undetectable viral load, have a CD4 count ≥ 200\u002FμL, and be on anti-retroviral therapy. HIV positive patients should be monitored per local\u002Finstitutional standards while receiving study treatment\n* Patients with a history of progressive multifocal leukoencephalopathy\n* Pregnancy or lactation or intending to become pregnant during study\n* ARM B ONLY: Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* ARM B ONLY: Known or suspected chronic active Epstein-Barr virus infection\n* ARM B ONLY: Current or past history of Waldenström macroglobulinemia\n* ARM B ONLY: Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, CNS lymphoma or neurodegenerative disease\n* ARM B ONLY: Active autoimmune disease which is not well controlled by therapy\n* ARM B ONLY: Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible\n* ARM B ONLY: Participants with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n* ARM B ONLY: Participants with active autoimmune disease with dermatologic manifestations are eligible for the study\n* ARM B ONLY: Participants with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, multiple sclerosis, or glomerulonephritis will be excluded\n* ARM B ONLY: Participants with a history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barré syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune disease will be excluded unless they have not required systemic therapy in the last 12 months\n* ARM B ONLY: Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis\n* ARM B ONLY: Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)\n* ARM B ONLY: Grade 3 infection within 4 weeks of treatment initiation","ALL","18 Years",{"count":19,"type":20},56,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.",[26,27,28,29,30,31,32,33,34],"Aggressive Non-Hodgkin Lymphoma","ALK-Positive Large B-Cell Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Primary Mediastinal Large B-Cell Lymphoma","T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","Gray-Zone Lymphoma","RECRUITING","2026-02-27",{"date":38,"type":39},"2026-03-03","ACTUAL",{"date":41,"type":39},"2020-10-27",{"date":43,"type":20},"2031-12-01",{"name":45,"class":46},"University of Washington","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":47},"100459310","phase-2-car-t-cell-therapy-mosunetuzumab-and-polatuzumab-for-treatment-of-refractoryrelapsed-aggressive-non-hodgkins-lymphoma-nhl-100459310","NCT05260957","CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory\u002FRelapsed Aggressive Non-Hodgkin's Lymphoma (NHL).","ML43165 - Single Arm Phase 2 Trial of an FDA Approved Anti-CD19 CAR-T Therapy Followed by Mosunetuzumab and Polatuzumab Consolidation for the Treatment of Refractory\u002FRelapsed Aggressive NHL.","Inclusion Criteria:\n\n1. Histologic diagnosis of:\n\n   1. Diffuse large B cell lymphoma (DLBCL) not otherwise specified. Patients with primary cutaneous DLBCL of leg-type are eligible if the lymphoma expresses cluster of differentiation 19 (CD19) and if the insurance approves the CAR-T therapy. Similarly. Large cell transformation of nodal or extra-nodal marginal zone lymphoma is eligible only if the insurance allows and the disease shows strong CD19 positivity. On the other hand, post-transplant lymphoproliferative disorders (PTLD) are not allowed due to the frequently required continuation of immunosuppression to avoid organ rejection.\n   2. Primary mediastinal B cell lymphoma (PMBCL)\n   3. Transformed follicular lymphoma (TFL). An untransformed follicular lymphoma grade 3B will be considered on a case by case basis, since the genetic signature of grade 3B follicular lymphoma frequently resemble that of DLBCL and the large lymphomatous cells just happen to be organized in a follicular pattern. Recently, Breyanzi has an FDA indication for follicular lymphoma grade 3B.\n   4. High grade B cell lymphoma (HGBL), other than B-lymphoblastic lymphoma\n   5. Mantle Cell lymphoma (MCL)\n   6. Burkitt lymphoma (BL): Although very few reports inform us about the outcome of relapsed\u002Frefractory BL, encouraging activity including CRs have been reported with CAR-T and these patients are in need because they do not have enough options available. We will need insurance approval for such enrollment.\n2. Additionally, the lymphoma has to be in one of the following status:\n\n   1. Primary refractory which for the purpose of this study is defined as failure to obtain any response (PR or CR) after at least 3 cycles of anthracycline-based therapy or persistent disease after 6 cycles of anthracycline-based therapy as documented by a PET\u002FCT scan that is done no later than 2 months after the last (usually the 6th) cycle of primary chemotherapy. In questionable cases, a biopsy should confirm persistence of disease as part of standard of care. In case of mantle cell lymphoma, the primary therapy if does not include an anthracycline, should include either high doses of cytarabine +\u002F-bendamustine and an anti-CD20 antibody (usually rituximab).\n   2. Relapsed disease that fails to respond (CR or PR) after at least 2 cycles of a platinum and\u002For cytarabine-based chemotherapy. For the purpose of this study, appropriate regimens include: rituximab, ifosfamide, carboplatin and etoposide (R-ICE), rituximab, dexamethasone, cytarabine, and cisplatin (R-DHAP), rituximab dexamethasone cytarabine oxaliplatin (R-DHAOx), rituximab, gemcitabine, cisplatin, and dexamethasone (R-GDP). Rituximab, gemcitabine, and oxaliplatin (R-Gem-Ox) is considered appropriate if the patient fails to obtain at least a PR after 4 doses of oxaliplatin. Patients with MCL who relapse after an anthracycline, bendamustine or cytarabine-based regimen, should have failed two salvage attempts: a molecularly targeting-based regimen including at least a Bruton's tyrosine kinase (BTK) inhibitor with or without venetoclax and a cytotoxic traditional second salvage regimen, unless the two salvage approaches are combined. For example if they fail a salvage with R-ICE + a BTK-inhibitor in combination, they are eligible without the need to be exposed to more therapy. Patients with PMBCL, they should also have failed a traditional salvage regimen and a programmed cell death protein 1 (PD-1) inhibitor-based salvage.\n   3. Relapse after an autologous stem cell transplantation. At least 3 months should have lapsed between autologous stem cell infusion and initiation of pre-CAR-T lymphodepleting chemotherapy due to the risk of prolonged cytopenias.\n3. At least one of the lymphoma lesions should be measurable. For the purpose of this study an involved nodal lesion should be at least 1.5 cm in the longest diameter, while extra-nodal lymphoma lesions should have their longest diameter ≥1.0 cm\n4. Lymphoma cells need to be CD19 positive. In case of previous therapy with an anti-CD19 agent (including but not limited to blinatumomab, tafasitamab, loncastuximab tesirine), a new biopsy should be performed to confirm CD19 positivity.\n5. The performance status of the patient as measured by the Eastern Cooperative Oncology Group (ECOG) performance scale should be 0 - 2 (ECOG performance status (PS):0-2).\n6. Only adult patients will be eligible (patient age \\>18 years old). Patients up to 80 years old will be considered to participate in the study assuming they fulfill all the other inclusion criteria\n7. The creatinine clearance as measured by the Cockcroft-Gault equation should be 50 mL\u002Fmin or better (CrCl ≥ 50 mL\u002Fmin).\n8. Unless the patient has a known Gilbert syndrome, the total Bilirubin should be less that 1.5 x upper limit of normal (ULN) and both the transaminases (ALT and AST) should be less than 2.5 x ULN. The only exception to this rule is lymphoma infiltration of the liver where values of total Bilirubin up to 3 x ULN and transaminases up to 5 x ULN will be allowed after communication with the Principal Investigator (P.I. or his\u002Fher designee)\n9. The ejection fraction of the left ventricle as it is estimated on the Echocardiogram (preferably) or on the multigated acquisition (MUGA) scan should be at least 45% (LVEF ≥ 45%).\n10. The oxygen saturation of oxyhemoglobin on room air as measured by pulse oximetry should be at least 94% (O2Sat ≥ 94%). If a technical problem (artifact) is suspected on pulse oximetry, arterial blood gases will be obtained for more accurate measurement.\n11. On the day of screening and assuming there will be no other than the protocol therapy, the patient should have at least the following:\n\n    1. Absolute neutrophil count \\>1000\u002Fmicroliter,\n    2. Hg\\> 8 grams\u002F deciliter\n    3. Absolute lymphocyte count \\>250\u002Fmicroliter\n    4. Platelet count \\>75,000\u002Fmicroliter\n12. Patient should not have a transfusion of packed red blood cells (PRBCs) or platelets or receive erythropoietin analogues thrombopoietin receptor agonist (Tpo-mimetic), granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) for at least 5 days before the official determination of eligibility takes place.\n13. Patient should sign an informed consent and be willing to comply with the anticipated labs and clinic visits and should be willing to be hospitalized and undergo the required invasive procedures as directed by the treating Investigator.\n14. Female subjects should have a negative serum pregnancy test, unless they confirm their menopausal status and\u002For have undergone previous hysterectomy and\u002For oophorectomy.\n15. Both men and women with childbearing potential should agree to use effective contraception for the duration of the treatment and for at least 1 year after the last treatment since medications (e.g. cyclophosphamide) that will be used in the protocol can be harmful for the embryo.\n\nExclusion Criteria:\n\n1. Patients with EBV+DLBCL, plasmablastic lymphoma, human herpesvirus-8 (HHV-8) related B cell lymphoproliferative disorders including primary effusion lymphoma, anaplastic lymphoma kinase (ALK)+ LBCL, intravascular large B cell lymphomas, DLBCL associated with chronic inflammation, lymphomatoid granulomatosis, primary DLBCL of the CNS and T cell histiocyte rich LBCL will not be allowed because of different biology, frequent lack of CD19, difficulty in interpreting toxicity (as in the case of primary central nervous system (CNS) lymphoma) or some preliminary discouraging results with CAR-T as in the case of T-cell, histiocyte-rich large B cell lymphoma and Richter transformation of chronic lymphocytic leukemia (CLL).\n2. Primary CNS lymphoma or secondary CNS involvement by lymphoma.\n3. Similarly, patients with conditions that increase the risk of CNS toxicity will be excluded. Such conditions include but not limited to\n\n   1. active seizure disorder for which an antiepileptic is taken,\n   2. demyelinating diseases like multiple sclerosis\n   3. history of ischemic or hemorrhagic stroke in the last 2 years\n   4. Neurodegenerative disorders like Alzheimer and Parkinson\n   5. Cerebral edema or hydrocephalus of any cause\n4. Invasive sarcoma or carcinoma in the last 3 years, except from localized basal or squamous cell carcinomas of the skin, or cervical carcinoma in situ. Localized Gleason \\\u003C7, prostate-specific antigen (PSA)\\\u003C10 prostatic adenocarcinoma T1-2N0M0 under active surveillance is allowed.\n5. Myocardial infarction or unstable angina or coronary revascularization within 6 months of protocol enrollment is not allowed. Stable angina that requires nitrates for pain relief is not allowed either because of concerns of hypotension during the CRS period.\n6. Systemic hypertension that is not controlled with maximum three antihypertensives to a level of \\\u003C160\u002F100 precludes enrollment.\n7. Uncontrolled invasive infection, including fungal pneumonia, fungal sinusitis or fungal encephalitis are not allowed and should be resolved completely before enrollment. Cytomegalovirus (CMV) viremia\\>200 copies\u002Fmicroliter or EBV viremia \\> 1000 copies\u002Fmicroliter are not allowed unless treated completely in the case of CMV viremia and the patient then is placed on prophylactic letermovir.\n8. Patients with history of macrophage activation syndrome (MAS)\u002Fhemophagocytic lymphohistiocytosis (HLH) and patients with known or suspected chronic active Epstein Barr Virus infection (CAEBV).\n9. HIV positivity is allowed as long as the viral load of HIV-1 is less than 200 copies\u002Fmicroliter the last 3 months and the patient continue at least 3 antiretroviral agents during therapy.\n10. Chronic hepatitis B should have been controlled to hepatitis B virus (HBV) viral load \\\u003C200 copies\u002Fmicroliter and patients with chronic hepatitis B or even with just history of exposure to hepatitis B (hepatitis B core antibody positive but surface antigen negative) should be on suppressive therapy with entecavir, lamivudine or equivalent.\n11. Patients with hepatitis C and clearance of the virus with previous therapy are allowed as long as they do not suffer from chronic liver dysfunction. Patients with chronic hepatitis C and normal hepatic function should be cleared by a Hepatologist before inclusion and at least an elastogram and an ultrasound should be performed to r\u002Fo well-compensated cirrhosis.\n12. Autoimmune disorders including rheumatoid arthritis, severe psoriasis, systemic lupus erythematosus, scleroderma with pulmonary involvement, polymyositis, systemic vasculitis and inflammatory bowel disease requiring treatment with more than oral budesonide or nonacetylated salicylates are not allowed. Similarly pneumonitis, including cryptogenic organizing pneumonia, bronchiolitis obliterans or eosinophilic pneumonias or sarcoidosis affecting the lung parenchyma are not allowed. Guillain Barre, autoimmune hepatitis and autoimmune encephalitis as well as glomerulonephritis with nephrotic or nephritic syndrome are not allowed. Addison is allowed but prednisone daily dose should be less than 10 mg\u002Fd. Hashimoto thyroiditis is allowed as long as the patient has well controlled thyroid function with supplemental levothyroxine. Grave's disease has to be in excellent control with previous surgery or radioiodine or with methimazole with or without beta blockers but not glucocorticosteroids and patients will need endocrinology consultation before the enrollment.\n13. Other causes of congenital or acquired immunodeficiencies other than common variable immunodeficiency or immunoglobulin A (IgA) deficiency are not allowed.\n14. External drains including pericardial, pleural, peritoneal, external biliary drains or nephrostomies are not allowed.\n15. Use of prednisone for any reason should not be \\>10 mg\u002Fd. All other systemic immunosuppressive agents are not allowed.\n16. Any biologic agent interfering with the immune system function or cytotoxic chemotherapy are not allowed within 21 days of the first dose of mosunetuzumab. Radiation is not allowed within 14 days of the first mosunetuzumab administration. If temporary control of the lymphoma is required, only dexamethasone 20 mg\u002Fd for up to 5 days before the first administration of mosunetuzumab is allowed.\n17. Patient should not have anti-human leukocyte antigen (HLA) antibodies that make them refractory to platelets transfusions.\n18. If patients are on systemic antiplatelet or anticoagulant therapy, this therapy has to be stopped. Patients can continue low dose acetylsalicylic acid (ASA) up to 100 mg\u002Fd that will be also stopped when platelets drop below 75,000\u002Fmicroliter at any point during therapy. Non catheter-related deep venous thrombosis or pulmonary embolism that happened less than 3 months before protocol enrollment are not allowed.\n19. Any cardiac disease in addition to left ventricular ejection fraction (LVEF) \\\u003C45% that gives symptoms of heart failure (diastolic dysfunction or valvular abnormalities or dysrhythmias) and makes the patient belong to New York Heart Association (NYHA) II-IV functional group, automatically makes the patient ineligible.\n20. Previous anti-CD19 CAR-T therapy is not allowed.\n21. Uncontrolled Psychosis or cognitive impairment that makes the patient unable to make informed decisions preclude participation.\n22. Previous solid organ transplantation precludes participation.","80 Years",{"count":57,"type":20},22,[59],"PHASE2","The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.",[62,63,26],"Refractory Non-Hodgkin Lymphoma","Relapsed Non Hodgkin Lymphoma","2025-12-29",{"date":66,"type":39},"2025-12-31",{"date":68,"type":39},"2022-12-14",{"date":70,"type":20},"2028-12-31",{"name":72,"class":46},"Lazaros Lekakis"]