[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plasmablastic-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plasmablastic-lymphoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,48,77,104,136,170,192,241,264],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100469178","phase-1-pomalidomide-and-dose-adjusted-epoch---rituximab-for-hiv-associated-lymphomas-100469178",false,"NCT05389423","Pomalidomide and Dose-Adjusted EPOCH +\u002F- Rituximab for HIV-Associated Lymphomas","Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +\u002F- Rituximab for HIV-Associated Lymphomas","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed B-cell NHL confirmed by the Laboratory of Pathology (LP), NCI, with one or more of the following features:\n\n  * Leptomeningeal\u002FCSF involvement\n  * High-risk for CNS relapse per CNS-IPI (score 4-6)\n  * Plasmablastic histology\n  * Gamma herpesvirus positive tumor\n  * Presence of KS\n* Measurable or evaluable lymphoma.\n* Positive HIV1\u002F2 serology.\n* Individuals may not have received prior curative-intent chemotherapy for lymphoma. Individuals who have received prior treatment as a bridge to curative-intent therapy will be considered per Protocol Chair discretion if \\>= 2 weeks since administration. Steroids given for any reason or rituximab given for multicentric Castleman disease may be given any time prior to treatment start.\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group performance status (ECOG-PS) \\\u003C=4\n* Individuals of childbearing potential (IOCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 2 weeks prior to and again within 1 day before starting the study drugs and must either commit to continued abstinence from penetrative vaginal intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before the participant starts taking pomalidomide and for 12 months after the last dose of combined chemotherapy.\n* Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to six (6) months after the last dose of the study drug(s). We also will recommend individuals able to father a child with IOCBP partners to ask the partners to be on an effective birth control (hormonal, intrauterine device (IUD), surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.\n* All individuals must agree to be registered into the mandatory POMALYST REMS(R)TM program and be willing and able to comply with the requirements of the POMALYST REMS(R)TM program.\n* Able to take aspirin 81mg orally daily or another substitute thromboprophylaxis.\n* Adequate organ and marrow function as defined below unless abnormalities are attributed to lymphoma or HIV as determined by investigator:\n\n  * absolute neutrophil count \\>=1,000\u002FmcL\n  * platelets \\>=75,000\u002FmcL\n  * total bilirubin \\\u003C=1.5 X institutional upper limit of normal (individuals with history of Gilbert disease are eligible if total bilirubin \\\u003C= 5 mg\u002FdL with \\\u003C80% unconjugated bilirubin)\n  * aspartate aminotransferase (AST) \u002F alanine transaminase (ALT) \\\u003C=3 X institutional upper limit of normal\n  * creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for individuals with creatinine levels above institutional normal.\n* Hepatitis B virus (HBV) infection must be on suppressive antiviral therapy.\n* Willingness to take and adhere to ART (individuals are not required to be on any specific regimen of ART).\n* Individuals must understand and sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Individuals may not receive investigational agents on other clinical trials.\n* Requirement of any of the agents listed as prohibited thearapies.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide or other agents used in study.\n* Parenchymal brain involvement with lymphoma.\n* Ejection fraction less than 40% by echocardiography (ECHO)\n* CTCAEv5.0 Grade 3-4 neuropathy\n* History of malignant tumors other than KS or KSHV-associated multicentric Castleman Disease, (MCD), unless:\n\n  * In complete remission for \\>= 1 year from the time response was first documented; or,\n  * Completely resected basal cell carcinoma; or,\n  * In situ squamous cell carcinoma of the cervix or anus; or,\n  * Prior or concurrent malignancy has a natural history or treatment which does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per Protocol Chair discretion.\n* Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.\n* Symptomatic congestive heart failure\n* Unstable angina pectoris, symptomatic cardiac arrhythmia, or cardiac arrhythmia requiring medical treatment.\n* Uncontrolled intercurrent illness or participants considered to be of poor medical health due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection (excluding lymphoma or HIV) as documented in prior records or suggested by medical history, physical examination or standard clinical assessments such as imaging and laboratory studies.\n* Pregnant or nursing individuals (if lactating, must agree not to nurse while taking pomalidomide).","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Background:\n\nNon-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV. The disease may also be different in these two groups. More study is needed for treating\n\npeople with both HIV and NHL.\n\nObjective:\n\nTo test a study drug (pomalidomide) in combination with chemotherapy with or without another drug (rituximab) in people with HIV-associated NHL.\n\nEligibility:\n\nAdults aged 18 years or older diagnosed with HIV-associated B-cell NHL with high-risk features.\n\nDesign:\n\nIndividuals will undergo screening. They will have a physical exam. They will have blood and urine tests and tests of heart function. They may have imaging scans. Researchers will review tissue samples of individual s tumors. In some cases, a new biopsy may be needed.\n\nIndividuals will receive up to 6 cycles of treatment.\n\nThe first cycle is 26 days: Individuals will take pomalidomide by mouth for 10 days. After 5 days they will start receiving chemotherapy drugs through a tube attached to a needle placed in a vein (IV). Some participants will receive rituximab on day 5. All individuals will receive a second set of IV drugs that will last for 4 days (96 hours). They will receive another IV drug after the previous treatment is complete.\n\nThe remaining cycles are each 21 days. Individuals will take pomalidomide by mouth for the first 10 days. Other chemotherapy treatments will also be repeated starting on day 1 of each cycle.\n\nScreening tests will be repeated at study visits.\n\nFollow-up visits will continue for 4 years....",[26,27,28,29,30],"Diffuse Large Cell Lymphoma","Non-Hodgkin Lymphoma","Burkitt Lymphoma","Plasmablastic Lymphoma","B-Cell Neoplasm",[27,32,29,33,34],"Epstein Barr Virus","Chemotherapy","Immune Modulatory","RECRUITING","2026-06-27",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2023-06-27",{"date":43,"type":20},"2032-06-01",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"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":56,"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.",[60,61,62,63,64,65,66,29,67],"AIDS-Related Diffuse Large B-cell Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","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","Primary Effusion Lymphoma","NOT_YET_RECRUITING","2026-06-13",{"date":71,"type":39},"2026-06-16",{"date":73,"type":20},"2026-09-11",{"date":75,"type":20},"2028-04-30",{"name":45,"class":46},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100642541","phase-2-heme-25-open-label-feasibility-study-of-elranatamab-utilized-in-newly-diagnosed-plasmablastic-lymphoma-with-or-without-hiv-100642541","NCT07647432","HEME-25: Open-Label Feasibility Study of Elranatamab Utilized in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV","HEME-25: Open-Label Feasibility Study of Elranatamab Utilized in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV in Consolidation After Definitive Therapy","HEME-25","Inclusion Criteria:\n\n* Age ≥ 18 years at time of consent\n* ECOG performance status (PS) 0 or 1\n* Histologically and immunophenotypically confirmed PBL\n* Ann Arbor stage at initial diagnosis: stage I with lactate dehydrogenase (LDH) \\> upper limit of normal (ULN) and\u002For bulky disease \\>7.5 cm or stage II-IV\n* Received definitive front-line therapy for PBL with end-of-treatment PR or CR\n* Adequate bone marrow function with recovery from prior therapy, defined as:\n\n  * ANC ≥ 500 cells\u002FmcL\n  * Platelet count ≥ 50,000 cells\u002FmcL\n* Availability of archival tumor tissue (block or unstained slides) for mandatory central pathology review and correlative BCMA testing. Central pathology review and BCMA testing may be completed after enrollment.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. If a subject is unable to consent, a LAR may provide consent on their behalf.\n* As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n* If capable of becoming pregnant: Negative serum or urine pregnancy test\n* If HIV-positive:\n\n  * Receiving effective combined antiretroviral therapy\n  * CD4+ T-cell count ≥ 50 cells\u002FmcL within 4 weeks before enrollment\n\nExclusion Criteria:\n\nKey inclusion criteria:\n\n* Age ≥ 18 years at time of consent\n* ECOG performance status (PS) 0 or 1\n* Histologically and immunophenotypically confirmed PBL\n* Ann Arbor stage at initial diagnosis: stage I with lactate dehydrogenase (LDH) \\> upper limit of normal (ULN) and\u002For bulky disease \\>7.5 cm or stage II-IV\n* Received definitive front-line therapy for PBL with end-of-treatment PR or CR\n* Adequate bone marrow function with recovery from prior therapy, defined as:\n\n  * ANC ≥ 500 cells\u002FmcL\n  * Platelet count ≥ 50,000 cells\u002FmcL\n* Availability of archival tumor tissue (block or unstained slides) for mandatory central pathology review and correlative BCMA testing. Central pathology review and BCMA testing may be completed after enrollment.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. If a subject is unable to consent, a LAR may provide consent on their behalf.\n* As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n* If capable of becoming pregnant: Negative serum or urine pregnancy test\n* If HIV-positive:\n\n  * Receiving effective combined antiretroviral therapy\n  * CD4+ T-cell count ≥ 50 cells\u002FmcL within 4 weeks before enrollment\n\nKey exclusion criteria:\n\n* Prior BCMA bispecific therapy\n* Stable or progressive disease following front-line therapy as determined by the investigator\n* Receiving any other investigational agents\n* Expected survival \\\u003C 2 months\n* Known or suspected PBL involvement of the parenchymal brain or spinal cord at diagnosis. Asymptomatic leptomeningeal disease only will be allowed.\n* Uncontrolled intercurrent illness, including but not limited to uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Concurrent malignancy requiring active therapy within the last 3 years, except for the following:\n\n  * Basal cell carcinoma limited to the skin\n  * Squamous cell carcinoma limited to the skin\n  * Carcinoma in situ of the cervix or breast\n  * Adequately treated lentigo malignant melanoma\n  * Localized prostate cancer\n  * Active therapy consists of adjuvant or maintenance therapy to reduce the risk of recurrence of a malignancy that was previously treated with curative intent and with no evidence of active disease within 2 years prior to screening\n* Pregnant or nursing\n* PWH with a history of AIDS-defining opportunistic infection within the past year\n* Receipt of a live vaccine within 28 days prior to the first dose of study treatment",{"count":86,"type":20},17,[88,89],"PHASE2","PHASE3","This is a single-arm feasibility trial in which patients with histologically confirmed plasmablastic lymphoma (PBL) with or without HIV, who have achieved a Complete Response or Partial Response after definitive frontline chemotherapy, will receive Elranatamab (Elra) consolidation.",[29,92,93],"Hiv","Consolidation","2026-06-09",{"date":96,"type":39},"2026-06-15",{"date":98,"type":20},"2026-12-01",{"date":100,"type":20},"2030-12-01",{"name":102,"class":103},"University of Illinois at Chicago","OTHER",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100432756","phase-2-study-to-evaluate-combined-treatment-of-daratumumab-bortezomib-and-dexamethasone-in-pbl-patients-100432756","NCT04915248","Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.","An Open Label, Phase 2 Study to Evaluate Activity and Safety of Daratumumab in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Plasmablastic Lymphoma (DALYA Trial)","FIL_DALYA","Inclusion Criteria:\n\n1. Histologically confirmed plasmablastic lymphoma according to WHO 2017, CD38-positive by immunohistochemistry (≥5% of positive cells) Local diagnosis of PBL and local CD38 assessment ≥5% will suffice for enrollment and start of treatment.\n2. Patients with plasmablastic lymphoma relapsed or refractory:\n\n   * after at least one line of conventional-dose chemotherapy followed or not by autologous stem cell transplantation;\n   * after at least one line of conventional-dose chemotherapy and not eligible for salvage autologous or allogeneic transplantation;\n3. ECOG Performance Status ≤ 3;\n4. Age ≥ 18 years;\n5. Both HIV-negative and HIV-positive patients are eligible;\n6. HIV infection responsive to ongoing cART (combination antiretroviral therapy);\n7. At least one measurable disease lesion identifiable by imaging:\n\n   * A nodal lesion must be at least 11 mm x 11 mm OR ≥ 16 mm in the greatest transverse diameter (regardless of short axis measurement).\n   * An extranodal lesion must be at least 10 mm x 10 mm.\n8. Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and 7 months (for women) o 4 months (for men) after last administration of bortezomib or 6 months after last daratumumab dose, regardless of sex. A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control method (failure rate of less than 1%) e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, and sexual abstinence. The use of condoms by male patients is required unless the female partner is permanently sterile.\n\n   WOCBP must have two negative pregnancy tests as verified by the study doctor prior to starting study therapy and must agree to undergo monthly pregnancy testing during the course of the study and after end of study therapy if clinically indicated. This applies even if the subject practices complete abstinence from heterosexual contact.\n9. Subject understands and voluntarily signs and dates an informed consent form approved by an Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures\n10. Subject must be able to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n1. Histologic diagnosis different from confirmed plasmablastic lymphoma according to WHO 2017 and\u002For CD38 expression \\\u003C 5% of positive cells\n2. CNS involvement\n3. Patients with known hypersensitivity to the investigational drug or to product components or severe allergic or anaphylactic reactions to humanized products\n4. Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy including targeted small molecule agents within 14 days prior to the first dose of study drug\n5. Concomitant Kaposi sarcoma; however, patients with only skin involvement of KS can be included.\n6. Subject is:\n\n   * Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]. Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[HBcAb\\] ± antibodies to hepatitis B surface antigen \\[HBsAb\\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (HBsAb 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\n   * Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response \\[SVR\\], defined as aviremia at least 12 weeks after completion of antiviral therapy)\n7. Any history of another cancer during the last 5 years with the exception of non-melanoma skin tumors, in situ cervical carcinoma, or in situ breast cancer treated with curative intent with no history of metastatic disease.\n8. Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis or tuberculosis. Drugs for HIV treatment are allowed, as per local investigator prescription.\n9. Active ongoing infection from SARS-CoV-2.\n10. Screening laboratory values (due to causes different than lymphoma):\n\n    * Absolute neutrophil count (ANC) \\\u003C1.0 x 109\u002FL (unless secondary to documented marrow involvement by lymphoma)\n    * Platelet count \\\u003C75 x 109\u002FL\n    * Hemoglobin \\\u003C 7.5 g\u002FdL\n    * Alanine aminotransferase (ALT) and\u002For Aspartate aminotransferase (AST) \\> 3.5 times the upper limit of normal (ULN)\n    * Alkaline phosphatase \\> 3.5 times ULN\n    * Bilirubin \\> 2 times x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n    * Serum Creatinine Clearance \\\u003C 20 ml\u002Fh\n11. Subject has clinically significant cardiac disease, including:\n\n    * Myocardial infarction within 6 months before date of registration, or unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)\n    * Cardiac arrhythmia (Common Terminology Criteria for Adverse Events \\[CTCAE\\] current version Grade 2 or higher) or clinically significant ECG abnormalities. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \\> 470 msec\n12. Evidence of any other clinically significant uncontrolled condition(s)\n13. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent\n14. Breastfeeding women or women with a positive pregnancy test at screening",{"count":113,"type":20},28,[88],"It is an open-label, multicenter, phase II, single arm trial to Evaluate Activity and Safety of Daratumumab in combination with Bortezomib and Dexamethasone in patients about 28 patients with Relapsed or Refractory Plasmablastic lymphoma.",[29],[118,119,120,121,122,123,124,125],"Relapsed","Refractory","Plasmablastic","lymphoma","PBL","Daratumumab","Bortezomib","Dexamethasone","2026-05-29",{"date":128,"type":39},"2026-06-02",{"date":130,"type":39},"2022-07-11",{"date":132,"type":20},"2027-07-01",{"name":134,"class":103},"Fondazione Italiana Linfomi - ETS",18,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":169},"100490236","collecting-blood-and-tissue-sample-donations-for-research-for-hivaids-related-cancers-100490236","NCT05663502","Collecting Blood and Tissue Sample Donations for Research for HIV\u002FAIDS-Related Cancers","Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): A Companion Protocol to AMC Trials","Inclusion Criteria:\n\n* Participants must be at least 18 years of age\n* Participant must be HIV- positive and have a diagnosed malignancy. If participants are HIV-negative, they must have a newly diagnosed or recurrent malignancy that has an established scientific connection (e.g., shared etiology) to an AIDS- associated malignancy such as:\n\n  * classic Kaposi sarcoma\n  * transplant-associated Kaposi sarcoma,\n  * anal cancer,\n  * multicentric Castleman's disease,\n  * Epstein Barr Virus (EBV) -positive lymphoma\n  * plasmablastic lymphoma\n  * Hodgkin's lymphoma.\n\n    * For participants that are HIV-positive, HIV infection must be documented 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 antiretroviral therapy (ART) 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. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone \\[e.g., Truvada\\], which is exclusionary);\n      * HIV ribonucleic acid (RNA) detection by a licensed HIV RNA assay demonstrating \\> 1000 RNA copies\u002FmL;\n      * Any licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV Western blot confirmation or HIV rapid multispot antibody differentiation assay.\n* Participants with HIV infection, regardless of participation in an AMC clinical trial, must have a diagnosis of cancer, cancer or a condition that places them at a higher risk of cancer.\n* The investigator determines that the participant (or his\u002Fher legally authorized representative \\[LAR\\]) has the ability to provide informed consent and the participant or LAR provides written informed consent.",{"count":144,"type":20},200,"OBSERVATIONAL","This study collects blood and tissue samples for research of human immunodeficiency virus (HIV)\u002Facquired immunodeficiency syndrome (AIDS)-related cancers. Collecting blood and tissue samples and studying biomarkers in the laboratory may help doctors to learn how are biologic or genetic factors related to HIV and cancers that occur commonly in people living with HIV.",[148,149,150,151,152,153,154,29,155,156,157,158],"Anal Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","HIV Infection","Kaposi Sarcoma","Lymphoma","Malignant Solid Neoplasm","Multicentric Castleman Disease","Recurrent Kaposi Sarcoma","Recurrent Lymphoma","Recurrent Plasmablastic Lymphoma","Transplant-Related Kaposi Sarcoma","2026-05-28",{"date":161,"type":39},"2026-06-01",{"date":163,"type":39},"2023-05-10",{"date":165,"type":20},"2035-08-31",{"name":167,"class":168},"AIDS Malignancy Consortium","NETWORK",8,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":169},"100373198","early-phase-1-a-study-of-daratumumab-and-dose-adjusted-epoch-in-plasmablastic-lymphoma-100373198","NCT04139304","A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma","A Multicenter, Open-Label Feasibility Study of Daratumumab With Dose-Adjusted EPOCH in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV","Inclusion Criteria:\n\n* Participants must have histologically and immunophenotypically (via at least a core or ideally, incisional or excisional biopsy) documented plasmablastic lymphoma.\n* Stage II-IV disease (Ann Arbor staging criteria) or stage I disease with elevated lactate dehydrogenase (LDH) or bulky tumor (\\> 7.5 cm).\n* Known HIV status. At most 7 HIV negative patients will be allowed on the study. Once 7 HIV negative patients have been enrolled, future enrollment will allow only HIV positive patients. Participants may be HIV positive, with documentation of HIV 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 highly active antiretroviral therapy (HAART) (at least three different medications) by a licensed health care provider (documentation may be a record of an HAART prescription in the participant?s medical record, a written prescription in the name of the participant for HAART, or pill bottles for HAART with a label showing the participant?s name);\n  * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \\>1000 RNA copies\u002FmL;\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: A ?licensed? assay refers to a U.S. Food and Drug Administration (FDA)-approved assay, which is required for all Investigational New Drug (IND) studies.\n  * Participants without HIV infection must have evidence of a negative result using any licensed HIV screening antibody assay and\u002For HIV antibody\u002Fantigen combination assay.\n* Participants must have measurable disease (unless marrow-only disease is present), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter) as \\>= 15 mm (\\>= 1.5cm) by computed tomography (CT) or positron emission tomography (PET) scan or evaluable by bone marrow.\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 50%).\n* Absolute neutrophil count \\>= 1,000 cells\u002FmcL unless decreased due to bone marrow involvement.\n* Platelets \\>= 75,000 cells\u002FmcL unless decreased due to bone marrow involvement.\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (\\\u003C 3.0 x ULN for patients with Gilbert syndrome). If, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =\\\u003C 3.5 mg\u002FdL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x the upper limit of normal.\n* AST (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002FALT (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN (=\\\u003C 5 x ULN is acceptable if liver metastases are present).\n* Creatinine =\\\u003C 1.5 x institutional ULN OR glomerular filtration rate (GFR) \\>= 45 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft-Gault formula.\n* Adequate cardiac function defined as an ejection fraction on echocardiogram (ECHO) or multigated acquisition scan (MUGA) that is at or above 45%.\n* CD4 count \\>= 100 cell\u002FmL for HIV-positive participants.\n* If HIV-positive, participant must not have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past year.\n* If HIV-positive, participant should have concurrent treatment with effective highly active antiretroviral therapy (HAART) or agree to start HAART.\n* The effects of daratumumab on the developing human fetus are unknown. For this reason and because another monoclonal antibody (mAb), rituximab, crosses the placenta and 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; abstinence) prior to study entry, the duration of study participation, and 90 days after completion of therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with female partners treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of daratumumab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Prior cytotoxic chemotherapy or radiotherapy for this lymphoma other than palliative radiation for medical emergencies (like cord compression) or the following chemotherapy:\n\n   • A maximum of one cycle of combination chemotherapy, including EPOCH or CHOP-like therapy. The start of the previous chemotherapy cycle must occur at least 21 days but no more than 28 days prior to the beginning of therapy under this protocol, and such cycle will count towards the maximum of 6 cycles under this study (i.e., cycle off study will count as cycle 1 in terms of feasibility determination as per primary endpoint).\n\n   OR\n\n   • One prior cycle of limited therapy including cyclophosphamide and\u002For glucocorticoids to improve performance status or hepatic or renal function impaired due to lymphoma involvement. The start of this therapy may occur up to 28 days prior to the beginning of study treatment under this protocol. Cyclophosphamide administration must have been completed at least 14 days prior to initiation of study treatment. Such treatment will not count towards the maximum of 6 cycles under this study (i.e., participants will receive 6 cycles on study).\n2. Patients who are receiving any other investigational agents.\n3. Participants must not have had previous anthracycline treatment within the last two years, except for liposomal doxorubicin. Any prior exposure to liposomal doxorubicin is allowed as long as the LVEF is ≥45%. It is at the discretion of the investigator if prior exposure to doxorubicin is acceptable.\n4. Participants who have previously received daratumumab for another indication.\n5. Participants must not be on cobicistat, indinavir, or ritonavir, or agents that are strong CYP3A4 inhibitors. If on a strong CYP3A4 inhibitor regimen prior to study enrollment, participants must be switched to alternative drugs at least one week prior to administration of study therapy.\n6. Participants with peripheral neuropathy grade ≥ 3 or neuropathic pain grade ≥ 2.\n7. Expected survival \\\u003C 2 months.\n8. Participants with known brain metastases from solid tumors will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n9. Patients with known or suspected parenchymal brain or spinal cord disease, and\u002For suspected or symptomatic leptomeningeal disease from lymphoma, prior to study enrolled will be excluded. Asymptomatic leptomeningeal disease only will be allowed.\n10. Patients who are seropositive for 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 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.\n11. Patients diagnosed with Hepatitis C who are Hepatitis C antibody positive, whether Hepatitis C RNA level is measurable or not, must have no evidence of cirrhosis and have liver function tests.\n12. History of allergic reactions, hypersensitivity, or intolerance attributed to compounds of similar chemical or biologic composition to daratumumab, or other agents used in the study or known sensitivity to mammalian-derived products.\n13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n14. Pregnancy or breastfeeding. A pregnancy test must be performed within 7 days prior to therapy administration in women of childbearing potential. Pregnant women are excluded from this study because the effects of daratumumab on the developing human fetus are unknown. Immunoglobulin G1 (IgG1) monoclonal antibodies are transferred across the placenta. Based on its mechanism of action, daratumumab may cause fetal myeloid or lymphoid-cell depletion and decreased bone density. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with daratumumab, breastfeeding should be discontinued if the mother is treated with daratumumab. These potential risks may also apply to other agents used in this study. Both male and female participants must use effective methods of birth control during the course of the study and for 3 months after stopping daratumumab. Participants must also agree to not donate eggs or sperm while taking daratumumab and for 3 months after stopping.\n15. Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the Principal Investigator.\n16. Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and\u002For the sponsor would compromise other protocol objectives. Participants with active opportunistic infections are ineligible.\n17. Major surgery, other than diagnostic surgery, occurring 4 weeks prior to study entry. Splenectomy will not be considered an exclusionary major surgery.\n18. Myocardial infarction (MI) within 6 months prior to study entry, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.\n19. Either of the following:\n\n    * Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) is \\\u003C50% of predicted normal. Note that FEV1 testing also is required for subjects suspected of having COPD and subjects must be excluded if FEV1 is \\\u003C50% of predicted normal.\n    * Known moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.)\n20. Participants with prior malignancies are ineligible unless:\n\n    * Treatment for the prior malignancy was completed at least 2 years prior to the lymphoma treatment start date and the participant has no evidence of the concurrent malignancy OR\n    * The concurrent malignancy is clinically stable and does not require tumor-directed treatment.",{"count":56,"type":20},[179],"EARLY_PHASE1","This feasibility trial studies how well daratumumab in combination with dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (DA-EPOCH) works in treating patients with newly diagnosed stage I-IV plasmablastic lymphoma. Plasmablastic lymphoma cells have high levels of a protein called CD38. Daratumumab is a monoclonal antibody that specifically targets CD38 expressing cells, and may help the body's immune system attack the cancer and interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, 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. Giving daratumumab may enhance the effectiveness of a standard chemotherapy (DA-EPOCH) in patients with plasmablastic lymphoma.",[29,182,183,184,185],"Ann Arbor Stage I Diffuse Large B-Cell Lymphoma","Ann Arbor Stage II Diffuse Large B-Cell Lymphoma","Ann Arbor Stage III Diffuse Large B-Cell Lymphoma","Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma",{"date":161,"type":39},{"date":188,"type":39},"2021-05-24",{"date":190,"type":20},"2030-07",{"name":167,"class":168},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":201,"briefSummary":202,"conditions":203,"keywords":227,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":240},"100481055","phase-1-study-of-sgr-1505-in-mature-b-cell-neoplasms-100481055","NCT05544019","Study of SGR-1505 in Mature B-Cell Neoplasms","A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies","Inclusion Criteria:\n\n* Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.\n* Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n* The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).\n* Subject has previous invasive malignancy in the last 2 years.\n* Subject has a known allergy to SGR-1505 or excipients of SGR-1505.\n* Subject has symptomatic or active CNS involvement of disease.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.",{"count":200,"type":20},98,[23],"The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and\u002For recommended dose (RD) of SGR-1505.",[204,205,206,207,208,209,210,211,212,28,29,213,214,67,215,216,217,218,219,220,221,222,223,224,225,226],"Mature B-Cell Neoplasm","Non Hodgkin Lymphoma","DLBCL","Waldenstrom Macroglobulinemia","MALT Lymphoma","Follicular Lymphoma","Pediatric-Type Follicular Lymphoma","IRF4 Gene Rearrangement","EBV-Positive DLBCL, Nos","High-grade B-cell Lymphoma","Primary Cutaneous Follicle Center Lymphoma","Mantle Cell Lymphoma","DLBCL Germinal Center B-Cell Type","Primary Mediastinal Large B Cell Lymphoma","T-Cell\u002FHistiocyte Rich Lymphoma","ALK-Positive Large B-Cell Lymphoma","Primary Cutaneous Diffuse Large B-Cell Lymphoma","Splenic Marginal Zone Lymphoma","Chronic Lymphocytic Leukemia","Nodal Marginal Zone Lymphoma","HHV8-Positive DLBCL, Nos","Lymphoplasmacytic Lymphoma","Duodenal-Type Follicular Lymphoma",[228,229,207],"MALT1","NF-kB","2026-02-11",{"date":232,"type":39},"2026-02-13",{"date":234,"type":39},"2023-04-10",{"date":236,"type":20},"2027-11",{"name":238,"class":239},"Schrödinger, Inc.","INDUSTRY",36,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":249,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":251,"conditions":252,"keywords":253,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},"100576135","study-on-plasmablastic-lymphoma-patients-100576135","NCT06781359","Study on Plasmablastic Lymphoma Patients","An International Multicenter Observational Retrospective Study on Plasmablastic Lymphoma Patients","FIL_PlaLy","Inclusion Criteria:\n\n* Diagnosis of plasmablastic lymphoma (PBL) between Jan 1st 2000, and Dec 31st 2022\n* Histologically confirmed plasmablastic lymphoma (PBL) diagnosis according to local pathological report\n* Age \\> 18 years old\n* Availability of complete medical records\n* Availability of histopathological material requested by the study\n\nExclusion Criteria:\n\n* Any other histology than PBL\n* Lack of complete medical records\n* Lack of histopathological material requested by the study","15 Years",{"count":144,"type":20},"This is an observational, multicenter, international and retrospective study, that aims to collect data on clinical and pathological characteristics, treatment regimens, outcome, and prognostic factors (clinical, biomarkers and\u002For radio-metabolic) in patients affected by PBL.",[29],[254,122],"Plasmablastic lymphoma","2025-12-01",{"date":257,"type":39},"2025-12-02",{"date":259,"type":39},"2025-02-14",{"date":261,"type":20},"2028-02-01",{"name":134,"class":103},23,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":21,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":47},"100601669","phase-1-rn1201injection-for-relapsedrefractory-cd19bcma-hematologic-malignancies-100601669","NCT07113496","RN1201injection for Relapsed\u002FRefractory CD19+\u002FBCMA+ Hematologic Malignancies","An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CAR-T Cell (RN1201) for Relapsed\u002FRefractory CD19+\u002FBCMA+ Hematologic Malignancies","Inclusion Criteria\n\n1. Voluntary participation with signed informed consent.\n2. Pathologically confirmed CD19-positive and\u002For B-cell maturation antigen (BCMA)-positive hematologic malignancy according to the WHO 2017 classification, including but not limited to multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), mature B-cell lymphomas, and plasmablastic lymphoma.\n3. Relapsed\u002Frefractory disease defined as failure to achieve complete remission after standard therapy, or relapse after an initial response during treatment or follow-up.\n4. Measurable disease required:\n\n   1. For B-ALL: persistent minimal residual disease (MRD) positivity despite hematologic remission.\n   2. For lymphoma: at least one measurable lesion ≥1.5 cm in longest diameter per IWG revised criteria.\n   3. For multiple myeloma: positive immunofixation electrophoresis or presence of extramedullary disease.\n5. Age ≥18 years; both sexes eligible.\n6. Expected survival ≥12 weeks.\n7. Adequate organ function (exceptions for disease-related impairment are at the investigator's discretion):\n\n   1. Total bilirubin \\\u003C2× upper limit of normal (ULN); serum creatinine \\\u003CULN; ALT and AST \\\u003C3× ULN.\n   2. Absolute neutrophil count ≥0.5×10⁹\u002FL; platelets ≥20×10⁹\u002FL (no requirement if marrow involvement is documented).\n   3. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.\n   4. Left ventricular ejection fraction (LVEF) ≥50%.\n\nExclusion Criteria\n\n1. Known hypersensitivity, allergy, intolerance, or contraindication to CD19\u002FBCMA-UCAR-T or any study drugs (fludarabine, cyclophosphamide, tocilizumab).\n2. Genetic syndromes: Fanconi, Kostmann, Shwachman, or any documented bone-marrow failure syndrome.\n3. Active or uncontrolled infection requiring IV antibiotics; evidence of severe active infection.\n4. NYHA Class III or IV heart failure (unless clearly secondary to the underlying malignancy).\n5. Central Nervous System (CNS) disorders unrelated to the primary hematologic malignancy.\n6. Prior malignancy except adequately treated carcinoma in situ of skin, cervix, lung, or other non-active tumors.\n7. Significant bleeding diathesis (e.g., gastrointestinal (GI) bleeding, coagulopathy, hypersplenism).\n8. History of significant cardiac disease within the past 3 months that, in the investigator's judgment, renders the patient unable to tolerate study participation..\n9. Pregnancy, lactation, or planned pregnancy within 6 months.\n10. Any condition that, in the investigator's opinion, may increase risk or interfere with study results.",{"count":272,"type":20},27,[23],"This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+\u002FBCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status. The trial assesses overall response and disease control rates, treatment-emergent adverse events, and in vivo behavior of UCAR-T cells.",[276,277,278,29,279,280],"Relapsed or Refractory B-cell Hematologic Malignancies","B-cell Acute Lymphoblastic Leukemia (B-ALL)","Multiple Myeloma (MM)","Relapsed or Refractory CD19+\u002FBCMA+ Hematologic Malignancies","Mature B-Cell Lymphoma","2025-08-08",{"date":283,"type":39},"2025-08-13",{"date":285,"type":20},"2025-08",{"date":287,"type":20},"2027-12",{"name":289,"class":103},"The First Affiliated Hospital with Nanjing Medical University"]