[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-large-b-cell-lymphoma-not-otherwise-specified\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-large-b-cell-lymphoma-not-otherwise-specified":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,69,100,135,156,185,213],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100517310","phase-1-testing-the-combination-of-anti-cancer-drugs-mosunetuzumab-polatuzumab-vedotin-and-lenalidomide-for-the-treatment-of-relapsedrefractory-diffuse-large-b-cell-lymphoma-100517310",false,"NCT06015880","Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Phase 1 Study of Mosunetuzumab With Polatuzumab Vedotin and Lenalidomide (M+Pola+Len) in Relapsed\u002FRefractory (R\u002FR) Diffuse Large B-Cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n* Patients must have histologically confirmed DLBCL NOS, high-grade B-cell lymphoma, or transformed indolent lymphoma as per the World Health Organization 2022 criteria\n* All patients will have relapsed\u002Frefractory DLBCL after 1 or more prior lines of therapy with the exception of patients receiving CAR T in second line that have a D score of 3 at day (D)+ 30 through D+ 90\n* Patients who progressed\u002Frelapsed after prior polatuzumab vedotin are allowed\n* For the expansion cohorts only: cohort A must have Deauville score of ≥ 3 with the first 90 days) after standard of care chimeric antigen receptor (CAR) T-cell therapy; cohort B- other patients with relapsed\u002Frefractory after 1 or more prior lines of therapy (e.g. relapse after Day 90 from CAR-T, or relapsed after other therapies and were not considered candidates for CAR-T)\n* All patients that have failed 1 line of therapy will be eligible with the exception of a 12 patient cohort (A) that will require prior CAR T therapy\n* Measurable disease by CT or PET scan, with one or more sites of disease \\>= 1.5 cm in longest dimension\n* Age \\>= 18 years\n\n  * Because no dosing or adverse event data are currently available on the use of mosunetuzumab in combination with polatuzumab vedotin, and lenalidomide in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Life expectancy \\>= 12 weeks\n* Absolute neutrophil count \\>= 1,000\u002FmcL\n* Platelets \\>= 50,000\u002FmcL without transfusion for 2 weeks prior to cycle 1 day 1 (C1D1)\n* Hemoglobin \\>= 9 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 × institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\\\u003C 3 × ULN may be enrolled)\n* Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 × ULN (AST and\u002For ALT =\\\u003C 5 × ULN for patients with liver involvement)\n* Alkaline phosphatase =\\\u003C 2.5 × ULN (=\\\u003C 5 × ULN for patients with documented liver involvement or bone metastases)\n* Creatinine clearance \\>= 30 mL\u002Fmin\u002F1.73 m\\^2 by Cockcroft-Gault: (140- age) × (weight in kg) × (0.85 if female) 72 × (serum creatinine in mg\u002FdL)\n* International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 × ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose.)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n\n  * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging 6-8 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression or CNS lymphoma\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined below:\n\n  * Women must remain abstinent or use contraceptive methods with a failure rate of 1% per year during the treatment period and for 3 months after the final dose of mosunetuzumab, 3 months after the final dose of polatuzumab vedotin, and 1 month after the last dose of lenalidomide\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:\n  * With female partners of childbearing potential, men must remain abstinent or use a condom during the treatment period, 5 months after the final dose of polatuzumab vedotin, and 1 month after the last dose of lenalidomide\n* Some concurrent cancer therapeutics (e.g., prostate, breast hormonal-based therapy) are allowed\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Agree to comply with all local requirements of the lenalidomide risk minimization plan\n\nExclusion Criteria:\n\n* Plasmablastic lymphoma, primary mediastinal B-cell lymphoma, gray zone lymphoma\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents or treatments\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to mosunetuzumab or other agents used in study\n* Patients with uncontrolled intercurrent illness\n* Uncontrolled or known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and\u002For other treatment) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to first study treatment administration\n* Active CNS involvement or detectable disease by lymphoma, including leptomeningeal involvement\n* Pregnant women are excluded from this study because mosunetuzumab is bispecific antibody with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with mosunetuzumab, breastfeeding should be discontinued if the mother is treated with mosunetuzumab. These potential risks may also apply to other agents used in this study. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 3 months after the final dose of polatuzumab vedotin, and 1 month after the final dose of lenalidomide\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better\n* Known or suspected chronic active Epstein-Barr virus (EBV) infection\n* Patients with any other significant condition(s) that would make this protocol unreasonably hazardous\n\n  * Current \\> grade 1 peripheral neuropathy\n  * Prior solid organ transplantation\n  * Patients with known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n  * Patients with history of confirmed progressive multifocal leukoencephalopathy (PML)\n  * Currently active or uncontrolled autoimmune disease\n\n    * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\n    * Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n    * Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab, linked to a toxic agent called vedotin, attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsed\u002Frefractory DLBCL.",[26,27,28],"Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","RECRUITING","2026-06-16",{"date":32,"type":33},"2026-06-17","ACTUAL",{"date":35,"type":33},"2024-05-20",{"date":37,"type":20},"2027-06-30",{"name":39,"class":40},"National Cancer Institute (NCI)","NIH",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100642264","phase-1-amc-120-glofitamab-plus-chemoimmunotherapy-in-newly-diagnosed-hiv-associated-large-b-cell-lymphoma-the-glofit-rchop-study-100642264","NCT07649304","AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The \"Glofit-RCHOP Study\")","A Feasibility Study of Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Participant is able to understand and willing to sign a written informed consent document\n* Participants must have histologically (via at least a core or ideally, incisional or excisional biopsy) documented CD20 positive newly diagnosed HIV-associated LBCL as per World Health Organization (WHO) 5th edition, diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high grade B-cell lymphoma-NOS or DLBCL\u002Fhigh grade B-cell lymphoma with MYC and BCL2 rearrangement. Plasmablastic lymphoma and primary effusion lymphoma may be included only if CD20-positive\n* Stage II-IV disease (as per Lugano Staging Criteria) that is measurable as defined below:\n\n  * Measurable lymph nodes with longest diameter \\> 1.5 cm, or\n  * Measurable extranodal lesions with longest diameter \\> 1.0 cm\n  * Participants with bone marrow involvement only will be eligible as long as the morphological bone marrow involvement is documented on a bone marrow biopsy. These participants, however, will need to be willing to undergo subsequent bone marrow biopsies for response assessment and documentation\n* Evidence of HIV infection. Participants must have documentation of HIV-1 infection by means of any one of the following:\n\n  * Documentation of HIV diagnosis in the medical record by a licensed health care provider;\n  * Documentation of receipt of ART (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;\n  * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay at any time;\n  * Any licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.\n\n    * Note: The term \"licensed\" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., United States \\[US\\] Food and Drug Administration \\[FDA\\]).\n\nWorld Health Organization and Centers for Disease Control and Prevention guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E\u002FCIA that is based on a different antigen preparation and\u002For different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.\n\n* Participants with HIV must be on treatment with effective ART that is in accordance with the current International AIDS Society guidelines concurrently with chemotherapy. Use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) or ritonavir (includes Norvir® or Kaletra®), cobicistat, didanosine (Videx® or Videx EC®), or similar potent CYP3 inhibitors are prohibited. In order to be eligible, participants taking zidovudine or ritonavir, cobicistat, didanosine, or other CYP3 inhibitors must change to a different regimen 7 days prior to protocol therapy initiation. Changes to ART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.). Participants must be on ART for at least 7 days prior to initiation of protocol therapy except for ART-naïve participants who need to get started on ART within the 1st cycle of study treatment (before cycle 2 day 1). ART needs to be approved by protocol chair or co-chair prior to enrollment\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of glofitamab in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in participants \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥50%)\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FmcL unless decreased due to bone marrow involvement. Also, in participants with the Duffy antigen null phenotype, neutrophil counts may be lower and a lower threshold required for enrollment can be discussed with the protocol chair on a case-by-case basis\n* Platelets ≥ 75,000\u002FmcL unless decreased due to bone marrow involvement\n* Hemoglobin of ≥ 8 g\u002FdL unless decreased due to bone marrow involvement\n* Aspartate aminotransferase (AST \\[serum glutamic oxaloacetic transaminase (SGOT)\\])\u002Falanine aminotransferase (ALT \\[serum glutamate pyruvate transaminase (SGPT)\\]) ≤ 3 × institutional upper limit of normal (ULN; ≤ 5 × ULN is acceptable if secondary to liver involvement by lymphoma)\n* Total serum bilirubin ≤ 1.5 × institutional ULN (\\\u003C 3.0 × ULN for participants with Gilbert syndrome). If, however, the elevated bilirubin is felt to be secondary to ART, the total bilirubin must be ≤ 3.5 mg\u002FdL, provided that the direct bilirubin is normal and the AST and ALT ≤ 3 x the ULN\n* Glomerular filtration rate (GFR) no lower than 30 mL\u002Fmin\u002F1.73 m\\^2. GFR can be measured directly or estimated using the site's institutional standards\n* Participants must have adequate cardiac function defined as a left ventricular ejection fraction of at least 45% as determined by echocardiogram or multigated acquisition within 6 weeks before enrollment\n* The effects of glofitamab on the developing human fetus are unknown. For this reason and because CD20\u002FCD3 bispecific antibodies, as well as other therapeutic agents used in this trial, are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; total abstinence) from study entry and for at least 1 months from the last glofitamab administration or 12 months from the last rituximab administration, whichever is the longest. Women of childbearing potential, defined as pre- or perimenopausal females with an intact uterus, must have a negative serum β-HCG within 7 days prior to enrollment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Men treated with glofitamab must also agree to use adequate contraception with partners who are women of childbearing potential (condom plus an additional contraceptive method, such as bilateral tubal occlusion, male sterilization, hormone-releasing intrauterine devices, and copper intrauterine devices) or use contraceptive measures such as a condom with pregnant female partners to avoid exposing the embryo during intercourse, from study entry, for the duration of study participation, and 1 months after the last glofitamab dose or 12 months after completion of rituximab administration, whichever is the longest\n* Any CD4 count is allowed\n* Participants with leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy, except during the initial safety run-in phase, during which participants with leptomeningeal disease will be excluded. For the first three study participants, enrollment will be halted until the third participant completes two target doses (30 mg) of glofitamab and dose-limiting toxicity (DLT) assessment is completed\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents\n* Participants with active parenchymal central nervous system (CNS) lymphomatous involvement are excluded; however, asymptomatic leptomeningeal disease is allowed as long as participants have ongoing CNS directed therapy, except during the initial safety-run in phase, during which participants with leptomeningeal disease will also be excluded\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study\n* Uncontrolled intercurrent illness including, but not limited to: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (including, but not limited to clinically significant obstructive pulmonary disease or history of bronchospasm), clinically significant liver disease (including viral or other hepatitis or cirrhosis) or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would limit compliance with study requirements or make participation in this protocol unreasonably hazardous\n* Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with the study agent(s), breastfeeding should be discontinued if the mother is treated with the study agent(s). These potential risks may also apply to other agents used in this study\n* Participants with refractory HIV disease will not be eligible. Refractory HIV will be defined as prior ART exposure and HIV viral load \\> 1000 copies\u002FuL and no options for HIV control evaluated by HIV genotyping. Participants with HIV viral load \\> 1000 copies\u002FuL can be enrolled if additional ART will be initiated\n* Participants who have had chemotherapy other than allowable pre-trial therapy outlined below, or radiotherapy other than palliative radiation for medical emergencies (i.e., cord compression or impending fracture), within the last four weeks.\n\n  * Allowable prior therapy:\n\n    * A maximum of one cycle of combination chemotherapy, including CHOP ± rituximab and etoposide-prednisone-Oncovin-cyclophosphamide-hydroxydaunorubicin (EPOCH) ± rituximab. The start of previous chemotherapy cycle must occur at least 21 days but no more than 35 days prior to beginning treatment under this protocol, and this cycle will count towards the maximum of six cycles under this study (i.e., cycle received prior to study enrollment will count as cycle 1) OR\n    * One prior course of limited therapy including cyclophosphamide and\u002For glucocorticoids and\u002For rituximab to improve fitness for combination chemotherapy (i.e., those with impaired hepatic function, renal function and or performance status due to lymphomatous involvement). The start of this therapy may occur up to 35 days prior to beginning treatment under this protocol; cyclophosphamide administration must have been completed at least 14 days prior to initiation of protocol therapy. Such treatment will not count towards the maximum of six cycles under this study (i.e., participants will receive six cycles on study and start with cycle 1 of RCHOP)\n* Participants must not have had previous anthracycline treatment within the last two years, except for one cycle off protocol or liposomal doxorubicin. Any prior exposure to liposomal doxorubicin is allowed as long as the left ventricular ejection fraction is ≥ 45%. It is at the discretion of the investigator if prior exposure to doxorubicin more than two years prior is acceptable\n* Participants with active tuberculosis and other active opportunistic infections requiring active treatment\n* Participants with active fungal infection or history of opportunistic infection requiring continuous prophylaxis or treatment with fluconazole, voriconazole or posaconazole. Oral candidiasis or fungal nail bed infections are permitted\n* Participants with chronic hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]). All participants will be required to be screened for Hepatitis B. Participants with resolved infection (i.e., participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened using real-time polymerase chain reaction (PCR) measurement of Hepatitis B virus (HBV) DNA levels. Participants who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR. For participants who have evidence of prior Hepatitis B exposure and are PCR negative, hepatitis B (Hep B) reactivation prophylaxis is mandated using institutional guidelines\n* If hepatitis C antibody positive, participants will be excluded from study unless hepatitis C viral load is undetectable. Additionally, participants must have no evidence of cirrhosis and have liver function tests (LFTs)\n* Participants with baseline peripheral neuropathy \\> grade 2 or painful \\>\u002F= grade 2 neuropathy\n* Participants who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Concomitant medications: Participants should only be excluded from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy. Please include scientific or clinically based rationale for exclusion.\n\n  * Please note that this must account for all agents to be used on this study, including commercial agents. Please refer to the FDA product labels for all commercial agents and include information on prohibited concomitant medications in all applicable sections of the protocol\n  * A wash out period prior to the start of cycle 1 of at least 4 weeks for prior use of any monoclonal antibody, systemic immunotherapeutic agents, immunosuppressive agents (such as, but not limited to cyclosporin, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor) is required\n* Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the principal investigator (PI)\n* Major surgery, other than diagnostic surgery, occurring within 4 weeks prior to study entry. Splenectomy will not be considered an exclusionary major surgery\n* Having received a live, attenuated vaccine within 28 days prior to registration\n* Myocardial infarction within the preceding 3 months\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Prior diagnosis of progressive multifocal leukoencephalopathy (PML)\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following exceptions apply:\n\n  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for study\n  * Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids",{"count":49,"type":20},15,[23],"This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma. Glofitamab is a bispecific monoclonal antibody, which can bind to two different antigens that are expressed by cancer cells (CD3 and CD20) at the same time. This may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving glofitamab in combination with the R-CHOP regimen may be a safe treatment for patients with newly-diagnosed with HIV-associated large B-cell lymphoma.",[53,26,54,55,56,57,58,59,60],"AIDS-Related Diffuse Large B-cell Lymphoma","High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Lugano Classification Stage II Adult Non-Hodgkin Lymphoma AJCC v8","Lugano Classification Stage III Adult Non-Hodgkin Lymphoma AJCC v8","Lugano Classification Stage IV Adult Non-Hodgkin Lymphoma AJCC v8","Plasmablastic Lymphoma","Primary Effusion Lymphoma","NOT_YET_RECRUITING","2026-06-13",{"date":30,"type":33},{"date":65,"type":20},"2026-09-11",{"date":67,"type":20},"2028-04-30",{"name":39,"class":40},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100600428","phase-2-epcoritamab-with-dose-adjusted-etoposide-cyclophosphamide-vincristine-doxorubicin-prednisone-and-rituximab-epoch-r-for-the-treatment-of-aggressive-b-cell-non-hodgkin-lymphoma-100600428","NCT07097363","Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma","A Pilot Study of Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas","Inclusion Criteria:\n\n* Untreated aggressive large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to R-CHOP and in the opinion of the investigator would be treated with dose adjusted (DA)-EPOCH-R as standard of care. Subjects must be planned to receive full course (6 cycles) chemoimmunotherapy as per clinical standard of care. 1 prior cycle of chemoimmunotherapy may be allowed. Composite lymphomas are not excluded provided that the subject has not received 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  * Burkitt lymphoma\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 CT or FDG-PET\n* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS) at time of enrollment\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\u002FμL 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 clearance \\[CrCl\\]) ≥ 45 mL\u002Fmin\n\n  * Creatinine clearance should be calculated per institutional standard\n* Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) (Patients with documented Gilbert disease may be enrolled if total bilirubin ≤ 3.0 x ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver involvement\n* International Normalized Ratio (INR) ≤ 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 prothrombin Time (PT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy\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 ≤ 1% per year during the treatment period and for at least 12 months after the last dose of study treatment. 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 (≤ 12 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 ≤ 1% 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 treatment. 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\nExclusion Criteria:\n\n* Contraindication to any of the individual components of EPOCH-R, including, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products or if receiving an additional 6 cycles of anthracycline would place patient over the anthracycline lifetime cumulative dose (400 mg\u002Fm\\^2)\n* Prior systemic treatment for lymphoma. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response\n* Transformation from indolent lymphoma 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\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 therapy for large B-cell lymphoma except for patients who require lymphoma symptom control during screening may receive steroids and\u002For 1 cycle of chemoimmunotherapy in the following manner:\n\n  * 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. A maximum of 1 cycle of chemoimmunotherapy is allowed if needed for urgent disease stabilization if patient had staging PET\u002FCT and LVEF evaluation prior to chemoimmunotherapy; in this situation patients will receive therapy on study starting with cycle (C)1 day (D)8 epcoritamab provided the next cycle of EPOCH-R chemotherapy will not be delayed by \\> 7 days. In this situation, the date of receiving the first dose of EPOCH-R is considered C1D1 of the study treatment. Labs collected prior to C1D1, in accordance with SOC for the administration of these drugs, can be used for screening purposes\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 in the last 6 months\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\n  * If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection, the subject must have a negative molecular (e.g., polymerase chain reaction \\[PCR\\]) test or 2 negative antigen test results at least 24 hours apart. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen-failed and may only rescreen if the following have been met:\n\n    * At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms\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) deoxyribonucleic acid (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 HIV\n\n  * Patients with known diagnosis of HIV must have undetectable viral load and be on anti-retroviral therapy\n* Patients with a history of progressive multifocal leukoencephalopathy\n* Patients with known active central nervous system lymphoma\n* Patients needing a treatment regimen which would require use of mid-cycle high dose IV methotrexate for central nervous system (CNS) prophylaxis in the opinion of the treating provider\n* Pregnancy or lactation or intending to become pregnant during study",{"count":77,"type":20},18,[79],"PHASE2","This phase II trial tests the safety, best dose, and effectiveness of epcoritamab when given with etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab (EPOCH-R) for the treatment of patients with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a bispecific antibody that can bind to two different antigens at the same time. Epcoritamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The EPOCH-R is administrated as the standard of care treatment. This may help the immune system kill cancer cells. Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma.",[82,83,26,84,85,55,86,87,88],"B-Cell Non-Hodgkin Lymphoma","Burkitt Lymphoma","EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","Primary Mediastinal Large B-Cell Lymphoma","T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","Transformed B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma to Diffuse Large B-Ce","2026-04-21",{"date":91,"type":33},"2026-04-23",{"date":93,"type":33},"2025-12-07",{"date":95,"type":20},"2030-05-31",{"name":97,"class":98},"University of Washington","OTHER",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100553435","phase-2-a-study-of-wztl-002-car-t-cells-for-adults-with-relapsed-large-b-cell-lymphoma-100553435","NCT06486051","A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma","A Phase 2 Trial to Evaluate the Efficacy and Safety of WZTL-002 in Patients With Relapsed or Refractory Large B-cell Lymphoma (ENABLE-2)","ENABLE-2","Inclusion Criteria:\n\n1. Age 18 to 75 years (inclusive) at the time of informed consent\n2. Signed written informed consent for this trial\n3. Biopsy-proven relapsed or treatment-refractory B-cell non-Hodgkin lymphoma of the following subtypes, as per the 2022 WHO classification of haematolymphoid tumours\n\n   * Large B-cell lymphomas of the following histological subtypes:\n\n     * Diffuse LBCL, not otherwise specified\n     * Diffuse large B-cell lymphoma\u002Fhigh grade B-cell lymphoma with MYC and BCL2 rearrangements\n     * Large B-cell lymphoma with IRF4 rearrangement\n     * High grade B-cell lymphoma with 11q aberrations\n     * High grade B-cell lymphoma, not otherwise specified\n     * Primary mediastinal large B-cell lymphoma\n     * Follicular large B-cell lymphoma\n     * EBV-positive diffuse large B-cell lymphoma, not otherwise specified\n     * Diffuse large B-cell lymphoma associated with chronic inflammation\n     * Primary cutaneous DLBCL, leg type\n   * Large B-cell lymphoma of one of the above subtypes that has transformed from follicular or marginal zone lymphoma\n4. Received adequate first-line lymphoma therapy for the qualifying histology (as defined in inclusion criterion 3 above), comprising at least 2 cycles of a standard combination regimen incorporating an anthracycline and an anti-CD20 monoclonal antibody\n5. Relapsed or refractory disease meeting one of the following criteria:\n\n   * Relapsed or refractory within 12 months of first-line chemoimmunotherapy, defined as:\n\n     * Progressive disease following ≥ 2 cycles of chemoimmunotherapy, or\n     * Stable disease following ≥ 4 cycles of chemoimmunotherapy, or\n     * Partial response following ≥ 6 cycles of chemoimmunotherapy, or\n     * Complete response followed by biopsy-proven relapse within 12 months of completing first-line chemoimmunotherapy.\n   * Relapsed or refractory following second-line chemoimmunotherapy, defined as:\n\n     * Lack of complete response to, or relapse following, autologous stem cell transplantation as part of second-line therapy for the qualifying histology, or\n     * Inability to proceed to autologous stem cell transplantation due to lack of response to 2 cycles of second-line chemoimmunotherapy incorporating both a platinum agent and an anti-CD20 monoclonal antibody\n6. Positron emission tomography (PET) positive disease according to the Lugano 2014 criteria\n7. Available tumour tissue (comprising a tissue block or at least 6 unstained slides) for central histological review\n8. Lymphoma-related life expectancy at least 12 weeks, and life expectancy related to conditions other than lymphoma at least 12 months\n9. ECOG performance status of 0 or 1\n10. Adequate haematologic function, defined by:\n\n    * Neutrophils ≥ 1.0 × 10\\^9\u002FL, and Platelets ≥ 75 × 10\\^9\u002FL, and\n    * Lymphocytes ≥ 0.3 × 10\\^9\u002FL\n11. Adequate renal function, defined by estimated creatinine clearance (eCrCl) or glomerular filtration rate (eGFR) \\>\u002F= 45mL\u002Fmin using the Cockroft Gault estimation, CKD-EPI equation or as assessed by direct measurement.\n12. Adequate hepatic function, defined by serum bilirubin \\\u003C 2.5 × upper limit of normal (ULN) (unless attributable to Gilbert's syndrome) and alanine transaminase and aspartate aminotransferase \\\u003C 3 × ULN.\n13. Adequate lung function, defined as ≤ Grade 1 dyspnoea according to NCI CTCAE v5.0, and oxygen saturation (sO2) ≥ 92% on room air.\n14. Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram or multigated acquisition (MUGA), performed within 28 days of commencing screening.\n15. For female participants:\n\n    * Agree to use a condom if undertaking sexual activity with any partner during lymphodepleting chemotherapy, and\n    * If of reproductive potential agree to use a highly effective method of contraception from the time of enrolment until at least 12 months after administration of WZTL-002, or\n    * Are not of reproductive potential defined as either,\n\n      * being amenorrhoeic for at least 12 consecutive months with FSH 30 ≥ IU\u002FL, or\n      * previously undergone a sterilisation procedure\n16. For male participants:\n\n    * Agree to use a condom if undertaking sexual activity with any partner during lymphodepleting chemotherapy, and\n    * If undertaking sexual activity with a female partner of reproductive potential agree to use a highly effective method of contraception from the time of enrolment until at least 12 months after administration of WZTL-002, and\n    * Agree not to donate sperm for conception, or to provide gametes for in vitro fertilisation for at least 12 months after administration of WZTL-002\n17. Participant agrees not to donate blood components at any time after receiving WZTL-002\n\nExclusion Criteria:\n\n1. Active central nervous system (CNS) involvement by lymphoma. In patients with a history of CNS disease or a clinical suspicion of current CNS disease, lumbar puncture and MRI brain must be performed within 30 days of enrolment to exclude current CNS involvement.\n2. Active CNS pathology including: epilepsy, seizure within the preceding year, aphasia, paresis, stroke, dementia, psychosis within the preceding year, severe brain injury, Parkinson disease, or cerebellar disease\n3. B-cell non-Hodgkin lymphoma of the following subtypes, as per the 2022 WHO classification of haematolymphoid tumours:\n\n   * Richter transformation of chronic lymphocytic leukaemia\n   * T-cell\u002Fhistiocyte rich LBCL\n   * Primary LBCL of immune-privileged sites\n   * Fluid overload associated LBCL\n   * Fibrin-associated LBCL\n   * Plasmablastic lymphoma\n   * Mediastinal grey zone lymphoma\n   * Intravascular LBCL\n   * ALK-positive large B-cell lymphoma\n   * Lymphomatoid granulomatosis\n   * Burkitt lymphoma\n   * Primary effusion lymphoma\n   * KSHV\u002FHHV8-positive diffuse large B-cell lymphoma\n4. Patient has received 3 or more prior lines of therapy for LBCL, where 1 line of therapy is defined as 1 or more cycles of a combination chemoimmunotherapy with or without pre-planned consolidation therapy (radiotherapy, autologous stem cell transplant or immunotherapy)\n5. Requirement for urgent lymphoma therapy due to tumour-related symptoms, or due to imminent risk of blood vessel, airway, urinary tract, gastrointestinal tract, nerve or spinal cord compression\n6. Active autoimmune disease requiring current systemic immunosuppression\n7. Active sarcoidosis\n8. Prior solid organ transplantation or prior allogeneic stem cell transplantation (allo-SCT)\n9. Peripheral blood CD3+ T cells \\\u003C 150\u002FμL (0.15 x10\\^9\u002FL) as assessed by lymphocyte subset analysis\n10. History of active malignancy other than B-cell malignancy within 2 years prior to enrolment, with the exception of: adequately treated in situ carcinoma of the cervix; adequately treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin; other localised malignancy surgically resected (or radically treated with another treatment modality) with curative intent\n11. Prior treatment with:\n\n    * gene therapy (including CAR T-cell therapy) or CD19-targeted immunotherapy, or\n    * purine analogue (including bendamustine) or alemtuzumab within 6 months of enrolment, or\n    * bispecific T-cell engager, radiotherapy or an investigational medicine within 4 weeks of enrolment, or\n    * cytotoxic chemotherapy, systemic corticosteroids (at doses of ≥ 10 mg prednisone daily or equivalent), monoclonal antibody or antibody-drug conjugate (other than alemtuzumab) within 2 weeks of enrolment.\n12. Pregnant or lactating female\n13. Known sensitivity to immunoglobulin or to components of the IP\n14. Current or prior HIV infection\n15. Vaccination with a live virus within the 4 weeks of enrolment\n16. Inadequately-controlled systemic infection\n17. Serologic status reflecting active viral hepatitis B or active hepatitis C infection as follows:\n\n    * Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (or is \\\u003C 20 IU\u002FmL), and if they are willing to receive appropriate antiviral prophylaxis.\n    * Presence of active Hepatitis C infection as determined by Hepatitis C virus (HCV) RNA detected by PCR or nucleic acid testing (NAT). Patients with presence of HCV antibody, are eligible if HCV RNA is undetectable.\n18. Current New York Heart Association (NYHA) class 2 or higher cardiac symptoms, or myocardial infarction, unstable angina or other clinically significant cardiac disease within the past 6 months\n19. Significant concomitant illnesses which would in the Investigators opinion make the patient an unsuitable candidate for the trial\n20. Patients who have diminished capacity or any circumstance that would prohibit them from understanding and providing informed consent in accordance with ICH-GCP\n21. Patient does not provide consent to enrol to an International Cellular Therapy Registry","75 Years",{"count":110,"type":20},60,[79],"The goal of this clinical trial is to learn if a new type of chimeric antigen receptor (CAR) T-cell therapy called WZTL-002 is effective and safe for the treatment large B-cell lymphomas (LBCL) that have not responded to or have come back after standard chemotherapy. The main questions this trial aims to answer are:\n\n* What is the likelihood of complete response of the lymphoma after WZTL-002 treatment?\n* What is the risk of altered brain function (neurotoxicity) after WZTL-002?\n\nAll eligible participants will receive WZTL-002; the researchers will compare the complete response rate and neurotoxicity rate with historical groups of patients who were treated with similar therapies.\n\nParticipants will:\n\n* Have a procedure to gather white blood cells\n* Receive chemotherapy to prepare for the CAR T-cells\n* Receive WZTL-002 CAR T-cells through a vein\n* Be monitored closely for the first 14 days for certain side effects\n* Have scans 28 days and 3, 6, 12 and 24 months after WZTL-002 CAR T-cells to check if the treatment has worked",[114,26,115,116],"Large B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Transformed Non-Hodgkin Lymphoma",[118,119,120,121,122,123,124],"Chimeric Antigen Receptor Therapy","CD19 Antigen","Toll-Like Receptor 2","CD28 Antigen","Relapsed non-Hodgkin Lymphoma","Refractory non-Hodgkin Lymphoma","Adoptive Cellular Immunotherapy","2026-02-27",{"date":127,"type":33},"2026-03-03",{"date":129,"type":33},"2024-07-12",{"date":131,"type":20},"2028-06-30",{"name":133,"class":98},"Malaghan Institute of Medical Research",3,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":99},"100380306","phase-1-polatuzumab-vedotin-and-combination-chemotherapy-with-or-without-glofitamab-for-the-treatment-of-untreated-aggressive-large-b-cell-lymphoma-100380306","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",{"count":143,"type":20},56,[23],"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.",[147,148,26,84,85,55,86,87,149],"Aggressive Non-Hodgkin Lymphoma","ALK-Positive Large B-Cell Lymphoma","Gray-Zone Lymphoma",{"date":127,"type":33},{"date":152,"type":33},"2020-10-27",{"date":154,"type":20},"2031-12-01",{"name":97,"class":98},{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":167,"conditions":168,"keywords":173,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":99},"100569406","ctdna-guided-therapy-optimization-in-newly-diagnosed-dlbcl-100569406","NCT06693830","ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL","Sequencing-guided cHemotherapy Optimization Using Real-Time Evaluation in Newly Diagnosed DLBCL With Circulating Tumor DNA: SHORTEN-ctDNA","Inclusion Criteria:\n\n1. Patients with newly diagnosed, histologically confirmed CD20+ DLBCL\n\n   * Stage II-IV disease\n   * Planned for anthracycline-based therapy with standard dosed R-CHOP or R-pola- CHP without consolidative radiation\n   * Measurable disease on cross sectional imaging ≥ 1.5 cm in longest diameter and measurable in two perpendicular dimensions, with at least one corresponding hypermetabolic lesion by Lugano classification on baseline FDG PET\u002FCT or CT with intravenous contrast of the chest, abdomen, and pelvis if FDG PET\u002FCT not available.\n2. Age 18 years or older at time of screening\n3. Subject\u002Flegal representative willing and able to provide written informed consent\n4. Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for duration of study participation\n5. Organ function as assessed by laboratory and cardiac function testing and Eastern Cooperative Oncology Group (ECOG) performance status in appropriate range for receipt of R-CHOP or R-pola-CHP at standard dose as per treating physician\n\nExclusion Criteria:\n\n1. Previous treatment for diffuse large B-cell lymphoma, except as outlined below:\n\n   * Up to 14 days of corticosteroids for the relief of lymphoma-related symptoms\n   * A dose of pre-phase vincristine or rituximab\n   * One cycle of R-chemotherapy (including but not limited to R-CHOP, R-pola-CHP, dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab \\[DA-EPOCH-R) that has not started more than 28 days prior to consent\n   * Intrathecal chemotherapy for central nervous system (CNS) prophylaxis\n   * Radiation therapy for the treatment or prevention of spinal cord compression that has not started more than 28 days prior to enrollment\n2. Simultaneous participation in other treatment clinical protocol\n3. Planned anti-lymphoma therapies beyond R-CHOP or R-pola-CHP:\n\n   * Consolidative radiation to any baseline sites of disease\n   * Planned high-dose intravenous methotrexate for central nervous system (CNS) lymphoma prophylaxis (both mid-cycle and EOT excluded)\n\n     * Any number of doses of intrathecal chemotherapy for CNS lymphoma prophylaxis are allowed\n4. Transformed indolent lymphoma (including follicular lymphoma, marginal zone lymphoma, or lymphoplasmacytic lymphoma) or grade IIIB follicular lymphoma\n5. Known CNS involvement by lymphoma. R-CHOP and R-pola- CHP are insufficient to treat CNS disease.\n6. Any disease characteristics that would make R-CHOP or R-pola-CHP without radiation insufficient therapy at the discretion of the treating physician\n\n   * High-grade B-cell lymphoma with rearrangement of MYC and BCL2, primary mediastinal B-cell lymphoma, and HIV-associated lymphomas are excluded\n7. Richter transformation of chronic lymphocytic leukemia\n8. Pregnancy and\u002For nursing period. R-CHOP and R-pola-CHP may cause fetal harm or birth defects, and effects of exposure in the breastfed infant are unknown.\n\n   * A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"childbearing potential\"\n   * Women of childbearing potential are eligible if a negative serum or urine beta human chorionic gonadotropin pregnancy test is documented within 28 days of screening, and they must agree to us an effective contraception method during systemic treatment\n   * Men who have partners of childbearing potential must agree to use an effective contraceptive method during systemic treatment\n   * In addition to routine contraceptive methods, \"acceptable contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen.\n9. Uncontrolled active systemic infection\n\n   * Patients with a positive hepatitis B virus (HBV) core antibody and negative HBV surface antigen consistent with prior HBV exposure must be willing to take appropriate anti-viral prophylaxis.\n   * Patients with evidence of chronic HBV infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy.\n   * Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to consent.\n10. Active second malignancy unless in remission and with life expectancy \\> 2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin or carcinoma \"in situ\" of the cervix or breast who are eligible even if diagnosed within 2 years. If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at CUIMC, and after consultation with the Principal Investigator. Hormone therapy for treated prostate and breast cancer is allowed.\n11. Known hypersensitivity to any component of R-CHOP or R-pola-CHP",{"count":164,"type":20},40,[166],"NA","The purpose of this study is to 1) determine whether it is feasible to measure circulating tumor DNA (ctDNA) in real-time during standard treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL), and 2) evaluate the outcomes of participants with undetectable ctDNA in the middle of treatment who receive a shortened course of chemotherapy.\n\nThere are no investigational drug agents to be administered in this study. The investigational assay, phased variant enrichment and detection sequencing (PhasED-seq) will be used to guide de-escalation of standard-of-care therapy for newly diagnosed DLBCL.\n\nThe PhasED-seq assay has not yet been approved by the Food and Drug Administration (FDA).",[169,170,171,26,172],"Lymphoma","Lymphoma, B-Cell","Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma",[174,175],"circulating tumor DNA","measurable residual disease","2026-01-22",{"date":178,"type":33},"2026-01-23",{"date":180,"type":33},"2024-12-11",{"date":182,"type":20},"2029-12",{"name":184,"class":98},"Hua-Jay J Cherng, MD",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":212},"100509052","phase-1-a-phase-12-study-of-idp-121-in-patients-with-relapsedrefractory-hematologic-malignancies-100509052","NCT05908409","A Phase 1\u002F2 Study of IDP-121 in Patients With Relapsed\u002FRefractory Hematologic Malignancies","A Phase 1\u002F2 Multicenter, Open-label, Dose-escalation Study of IDP-121 in Patients With Relapsed\u002FRefractory Hematologic Malignancies (CASSANDRA)","CASSANDRA","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Performance status (ECOG) ≤ 2\n3. Life expectancy ≥3 months\n4. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.\n5. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.\n6. Patients diagnosed with chronic lymphocytic leukemia (CLL), B-cell lymphomas, and multiple myeloma (MM) who are ineligible to reveive the available treatments.\n7. Adequate hematological or biochemical parameters as specified below\n\n   1. Hemoglobin \\> 8.0 g\u002Fdl (without transfusion support within 7 days)\n   2. Platelets count \\> 75 x109\u002FL (without transfusional support within 7 days). In patients with bone marrow infiltration, the platelets count may be ≥50 x109\u002FL.\n   3. Absolute neutrophil count (ANC) \\> 0.75 x109\u002FL (without G-CSF support within 7 days)\n   4. Aspartate transaminase (AST): \\\u003C2.5 x the upper limit range (in patients with no liver metastases or \\\u003C5 x ULN in patients with liver metastases)\n   5. Alanine transaminase (ALT): \\\u003C 2.5 x the upper limit range (in patients with no liver metastases or \\\u003C5 x ULN in patients with liver metastases)\n   6. Total bilirubin: \\\u003C 2 x the upper limit range.\n   7. Calculated or measured creatinine clearance: \\>30 mL\u002Fmin (calculated from the Cockcroft-Gault formula).\n8. Left ventricular ejection fraction \\> 50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower, determined by echocardiogram.\n\nExclusion Criteria:\n\n1. Persistent clinically significant non-hematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade \\\u003C2 symptomatic peripheral neuropathy is allowed.\n2. Pregnant or lactating women; men and women of reproductive potential\\* (as defined in the Appendix 2) who are not using effective contraceptive methods (combined hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinenence).\n\n   \\*A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.\n3. History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site)\n4. History of clinically significant hypotension.\n5. History of clinically significant allergic or hyper-sensitivity reactions.\n6. History or known clinically significant vascular disease or known high risk of vascular disease (as assessed by the treating physician) including (but not limited to):\n\n   * Thromboembolism\n   * Peripheral arterial disease\n   * Vasculitis\n7. Other relevant diseases or adverse clinical conditions:\n\n   * Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.\n   * Uncontrolled arterial hypertension or cardiac arrhythmias (i.e., requiring a change in medication within the last 3 months or hospital admission within the past 6 months).\n   * History of significant neurological or psychiatric disorders\n8. Clinically significant or active infection.\n9. Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)\n10. The patient is known to be human immunodeficiency virus (HIV) positive, unless the patient is on antiviral therapy with HIV RNA levels \\\u003C50 copies\u002FmL; Hepatitis B surface antigen-positive or active hepatitis C infection, unless treated with undetectable hepatitis B DNA or hepatitis C RNA levels; or active CMV infection (IgM positive).\n11. Concomitant anti-tumor therapy within 14 days prior to Day 1 of Cycle 1.\n12. Prior allogeneic transplantation in the last 3 months or currently active GVHD with immunosuppressive treatment\n13. Limitation of the patient's ability to comply with the treatment or follow-up protocol.\n14. If a COVID-19 vaccine is administered, it should be done \\>72 hours prior to study treatment initiation or after the completion of the dose-limiting toxicity (DLT) period (if patient is participating in the dose-escalation phase\").",{"count":194,"type":20},37,[23,79],"The main aims of this 2-part study are:\n\n* Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 in patients with multiple myeloma (MM), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH\u002FTH) and HGBL-NOS, and chronic lymphocytic leukemia (CLL).\n* Phase II: To evaluate the overall response rate (ORR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS), event-free survival (EFS) and Overall survival (OS), in patients with MM, DLBCL-NOS, HGBL-DH\u002FTH, HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose (RP2D).",[198,26,199,55,200,201],"Multiple Myeloma (MM)","Double Hit Lymphoma","Chronic Lymphocytic Leukemia (CLL)","Triple Hit Lymphoma","2025-04-29",{"date":204,"type":33},"2025-05-01",{"date":206,"type":33},"2023-06-05",{"date":208,"type":20},"2026-03-22",{"name":210,"class":211},"IDP Discovery Pharma S.L.","INDUSTRY",11,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100534424","phase-2-epcoritamab-compared-to-observation-for-treating-b-cell-lymphoma-patients-not-in-complete-remission-after-cd19-directed-car-t-therapy-100534424","NCT06238648","Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy","Multicenter, Randomized Phase II Study of Epcoritamab for Patients With Aggressive B-Cell Lymphomas Achieving a Partial Response After CD19-Directed CAR-T Therapy","Inclusion Criteria:\n\n* Men and women \\>= 18 years of age\n* Documented histological confirmation of diffuse large b-cell lymphoma not otherwise specified \\[DLBCL NOS\\], primary mediastinal large b-cell lymphoma (LBCL), or transformations of indolent B-cell lymphomas, according to the 5th edition of World Health Organization (WHO) classification of lymphoid neoplasms, with CD20 positivity as determined by assessment of tumor cells =\\\u003C 6 months prior to registration pre- CAR-T biopsy specimen by immunohistochemistry or flow cytometry\n* Patients treated with the commercially available CD19-directed CAR-T products axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel), and who have a partial response at day 30 +\u002F- 7 days PET- CT assessment based on Lugano criteria (Deauville score of 4 or 5)\n* Documented measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2. (Form is available on the Academic and Community Cancer Research United \\[ACCRU\\] web site under Study Resources -\\> Forms)\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3, granulocyte colony stimulating factor (G-CSF) allowed (obtained =\\\u003C 14 days prior to registration)\n* Platelet count \\>= 50,000\u002Fmm\\^3 (obtained =\\\u003C 14 days prior to registration)\n* Hemoglobin \\>= 7.0 g\u002FdL if asymptomatic or hemoglobin \\> 8 if symptomatic; transfusion support allowed, if necessary (obtained =\\\u003C 14 days prior to registration)\n\n  * NOTE: symptoms include shortness of breath, fatigue, lightheadedness\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin or lymphoma involvement of the liver and total bilirubin is =\\\u003C 5 x ULN (obtained =\\\u003C 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement) (obtained =\\\u003C 14 days prior to registration)\n* Calculated creatinine clearance must be \\>= 45 mL\u002Fmin using the Crockcroft- Gault formula (obtained =\\\u003C 14 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms.\"\n* Negative serum pregnancy test done =\\\u003C 7 days prior to registration for a woman of childbearing potential (WOCBP) only\n\n  * NOTE: A WOCBP is a sexually mature female who:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy; or\n    * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Provide informed written consent =\\\u003C 28 days prior to registration\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study, i.e., active treatment and clinical follow-up)\n* Willing to provide mandatory tissue specimens and blood specimens for correlative research purposes\n\nExclusion Criteria:\n\n* Patients post CAR-T who have bulky disease defined as a disease focus \\>= 7.5cm in diameter at day 30 +\u002F- 7 days PET-CT assessment\n* Patients post CAR-T who have progressive disease, stable disease or complete response at day 30 +\u002F- 7 days PET-CT assessment based on Lugano criteria\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effect on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception (men and women)\n* Any of the following prior therapies:\n\n  * CD20xCD3 bispecific antibody at any point prior to registration\n  * CD20-targeted monoclonal antibody (e.g., rituximab, obinutuzumab or biosimilars) =\\\u003C 4 weeks prior to registration\n* Ongoing cytokine release syndrome (CRS) or neurotoxicity post CAR-T\n* Prior grade 4 CRS or neurotoxicity after most recently administered CAR-T\n* Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening and based on clinical symptoms, MRI, or lumbar puncture\n* Co-morbid systemic illness or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into the study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring systemic treatment (excluding prophylactic treatment) =\\\u003C 14 days prior to registration, including COVID- 19 infection.\n\n    * NOTE: If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable and on suppressive therapy.\n    * NOTE: If history of treated hepatitis C virus (HCV) infection, HCV viral load must be undetectable.\n    * NOTE: Patients known to be human immunodeficiency virus (HIV) positive, but stable on anti-retroviral therapy with an undetectable HIV viral load pre-CART, are eligible for this trial.\n    * NOTE: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment\n    * NOTE: Past COVID-19 infection may be a risk factor, but if resolved symptoms and the subject is vaccinated, they may be enrolled\n  * Symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class 3 or 4)\n  * Unstable angina pectoris\n  * Unstable cardiac arrhythmia present =\\\u003C 14 days prior to registration\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirement\n  * History or presence of CNS disorder such as seizure disorder (not including resolved childhood febrile seizures), cerebrovascular ischemia\u002Fhemorrhage (not including transient ischemic attacks), cerebellar disease, or any autoimmune disease with CNS involvement\n* Receiving any other investigational agent which would be considered treatment for the primary neoplasm =\\\u003C 14 days prior to registration\n* Other active malignancy requiring therapy \\\u003C 2 years prior to registration (localized non-melanoma skin cancer is allowed)\n* Clinically significant cardiovascular disease, including: Myocardial infarction within 1 year prior to randomization, or unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association class III-IV) cardiac arrhythmia (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0 grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities",{"count":221,"type":20},120,[79],"This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.",[26,86,28],"2024-09-24",{"date":227,"type":33},"2024-09-26",{"date":229,"type":33},"2024-01-31",{"date":231,"type":20},"2030-12-31",{"name":233,"class":98},"Academic and Community Cancer Research United",6]