[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AIDS Malignancy Consortium\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":272},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,40,66,98,121,141,177,199,223,246],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100644391","phase-2-epcoritamab-in-combination-with-dose-adjusted-epoch-r-for-high-risk-burkitt-lymphoma-bl-the-bedrock-study-100644391",false,"NCT07662928","Epcoritamab in Combination With Dose Adjusted EPOCH-R for High-risk Burkitt Lymphoma (BL), The BEDROCK Study","Epcoritamab in Combination With Dose Adjusted R-EPOCH for High Risk Burkitt Lymphoma (BL) (BEDROCK Study)","Inclusion Criteria:\n\n* Histologically and immunophenotypically (via at least a core or ideally, incisional or excisional biopsy) documented BL at the treating institution. All stages of BL are eligible\n* High-risk adult BL patients, as defined by:\n\n  * Stage I with any ONE of the following:\n\n    * A single lesion 10 cm or greater\n    * Elevated lactate dehydrogenase (LDH)\n    * Total resection of intra-abdominal disease with an elevated LDH after surgery OR\n  * Stage II or higher\n\n    * Either of the above PLUS ANY one of the following additional risk factors:\n\n      * Involvement of the bone marrow\n      * Involvement by the peripheral blood by morphology or flow cytometry\n      * Presence of leptomeningeal disease\n      * Age ≥ 40 years\n      * Lactate dehydrogenase \\> 3× upper limit of normal (ULN)\n      * Eastern Cooperative Oncology Group (ECOG) performance status 2-3\n* Treatment naive or one prior cycle of chemotherapy whether anthracycline based or not\n* If HIV positive and had an opportunistic infection within three months, participant must be recovered and willing to take prophylaxis as clinically indicated\n* If HIV positive, any CD4 count is acceptable\n* A minimum of two HIV-positive participants will be enrolled in Cohort 1 and a minimum of 10 HIV-positive participants will be enrolled in the randomized cohort. Once 18 HIV-negative participants are enrolled, future enrollment will allow only HIV-positive participants\n* Known HIV status. 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 a 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 United States 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 within 12 months before enrollment\n* If HIV positive, participant should have concurrent treatment with effective HAART or intend to start HAART shortly after enrollment\n* 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 calipers by clinical exam or evaluable by bone marrow. Tumor measurement can be assessed by treating physician. An official radiology reading does not need to be completed prior to enrollment\n* Adequate cardiac function defined as an ejection fraction on echocardiogram (ECHO) or multigated acquisition (MUGA) scan that is at or above 45% within six weeks before enrollment\n* Age ≥ 18 years\n* ECOG performance status ≤ 3. Patients with ECOG 3 must have poor performance status secondary to BL\n* Absolute neutrophil count: ≥ 1,000\u002FmcL unless attributed to BL (assessed within 2 weeks of enrollment)\n* Platelets: ≥ 100,000\u002FmcL unless attributed to BL (assessed within 2 weeks of enrollment)\n* Total bilirubin: ≤ institutional upper limit of normal (ULN) (assessed within 2 weeks of enrollment) unless attributed to Gilbert's on antiretroviral therapy (ART) in which case the direct bilirubin should be \\\u003C institutional ULN\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvate transaminase \\[SGPT\\]): ≤ 3 × institutional ULN (assessed within 2 weeks of enrollment), or if attributed to hepatic involvement by BL, the direct bilirubin should be \\\u003C 2x institutional ULN and the AST(SGOT)\u002FALT(SGPT): ≤ 5 × institutional ULN\n* Creatinine: ≤ institutional ULN OR glomerular filtration rate (GFR): ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 (assessed within 2 weeks of enrollment)\n* All participants will be required to be screened for hepatitis B. Participants with resolved infection (i.e., participants who are hepatitis B surface antigen negative but positive for antibodies to hepatitis B core antigen and\u002For antibodies to hepatitis B surface antigen must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Participants who are hepatitis B core positive or PCR positive must begin suppressive therapy. Participants with hepatitis B or PCR positivity must be followed by a hepatologist for serial testing. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (hepatitis B core antigen 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* For participants with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection previously treated and cured are eligible. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Participants incidentally found to have hepatitis C during screening with a measurable HCV viral load are not eligible\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* Participants 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, participants should be class II or better\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* Women of childbearing potential and men must be willing to use contraception during the study treatment and for four months after the last dose of study drug and agree to inform treating physician immediately of suspected pregnancy\n\nExclusion Criteria:\n\n* Brain or spinal cord parenchymal disease\n* Prior cytotoxic chemotherapy or radiotherapy for this lymphoma other than the following:\n\n  * Palliative radiation for medical emergencies (like cord compression)\n  * A maximum of one cycle of combination chemotherapy, including EPOCH or cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)-like therapy. The start of the previous chemotherapy cycle must occur at least 21 days but no more than four weeks prior to the beginning of therapy under this protocol, and such cycle will count towards the maximum of six cycles under this study (i.e., cycle off study will count as Cycle 1).\n\nOR\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 four weeks 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 six cycles under this study (i.e., participants will receive six cycles on study)\n\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  * Any prior exposure to liposomal doxorubicin is allowed as long as the left ventricular ejection fraction (LVEF) is ≥ 45%. It is at the discretion of the investigator if prior exposure to doxorubicin for an unrelated malignancy is acceptable\n  * Participants with peripheral neuropathy Grade ≥ 3 or neuropathic pain Grade ≥ 2\n  * 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 (AEs)\n  * Participants with Hepatitis C (Hepatitis C antibody positive) with cirrhosis, whether Hepatitis C RNA level is measurable or not\n  * History of allergic reactions, hypersensitivity, or intolerance attributed to compounds of similar chemical or biologic composition to agents used in the study\n  * Participants must not have any condition that would make participation in this protocol unduly hazardous\n  * A pregnancy test must be performed within seven days prior to therapy administration in women of childbearing potential. Pregnant women are excluded from this study because the effects of epcoritamab on the developing human fetus are unknown. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with bispecific antibodies and chemotherapy, breastfeeding should be discontinued prior to treatment initiation and will not be permitted during treatment and for four months after the final treatment dose. Both male and female participants must use effective methods of birth control during the course of the study and for three months after stopping treatment. Participants must also agree to not donate eggs or sperm while taking the study drugs and for three months after stopping\n  * Unable to provide adequate informed consent in the opinion of the Principal Investigator (PI)\n  * Major surgery, other than diagnostic surgery, occurring within four weeks prior to study entry. Splenectomy will not be considered an exclusionary major surgery\n  * Myocardial infarction within six months prior to study entry, New York Heart Association 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\n  * Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in one second (FEV1) is \\\u003C 50% of predicted normal. Note that FEV1 testing also is required for participants suspected of having COPD and participants must be excluded if FEV1 is \\\u003C 50% of predicted normal\n  * Known moderate or severe persistent asthma, or a history of asthma within the last two years, or currently has uncontrolled asthma of any classification. Participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study\n  * Participants who are receiving any other investigational agents\n  * History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab, or other agents used in this study\n  * Participants on cobicistat, indinavir, or ritonavir, or agents that are strong CYP3A4 inhibitors as these increase the toxicity of doxorubicin and vincristine. If on a strong CYP3A4 inhibitor regimen prior to study enrollment, participants must be switched to alternative drugs ideally one week prior to administration of study therapy. Exceptions must be noted on the eligibility form. All concomitant medications must be reviewed by the study chair or co-chair prior to enrollment by email\n  * Participants with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous","ALL","18 Years",{"count":19,"type":20},43,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies how well epcoritamab works in combination with the chemotherapy regimen dose adjusted etoposide, prednisone, Oncovin (vincristine), cyclophosphamide, hydroxydaunorubicin-rituximab (DA-EPOCH-R) in treating patients with high risk Burkitt lymphoma. Epcoritamab binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Epcoritamab is a type of bispecific T-cell engager. 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. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. 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. 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. Giving epcoritamab in combination with the DA-EPOCH-R regimen may be an effective treatment for patients with high risk Burkitt lymphoma.",[26],"Adult Burkitt Lymphoma","NOT_YET_RECRUITING","2026-06-17",{"date":30,"type":31},"2026-06-23","ACTUAL",{"date":33,"type":20},"2026-09-17",{"date":35,"type":20},"2033-04-30",{"name":37,"class":38},"AIDS Malignancy Consortium","NETWORK",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100435381","impact-of-behavior-modification-interventions-and-lung-cancer-screening-on-smoking-cessation-in-people-living-with-hiv-a-feasibility-study-100435381","NCT04949464","Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study","Inclusion Criteria:\n\n* Able to understand and willing to sign a written informed consent document\n* HIV positive. 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 antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \\[PrEP\\] or post-exposure prophylaxis \\[PEP\\]) 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 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\nNote: 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., U.S. Food and Drug Administration \\[FDA\\]).\n\nWHO (World Health Organization) and CDC (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* Receiving antiretroviral therapy and CD4 count at least 200 cells\u002FuL within 6 months of registration (due to increased risk of LDCT false positivity with CD4 count \\\u003C 200cells\u002FuL)\n* Age 45-80 years. This age restriction reflects lung cancer risk and appropriateness for lung cancer screening; in epidemiologic studies lung cancer emerges 5-10 years earlier in PLWH, and therefore this is an appropriate risk group for screening. Although younger persons are likely to benefit more from smoking cessation as a lung cancer prevention measure, the risk\u002Fbenefit ratio associated with lung cancer screening is unlikely to be optimal at ages \\\u003C 45 years for PLWH\n* Biochemically confirmed current smoker (exhaled carbon monoxide \\[CO\\] \\>= 7 parts per million)\n* Meets United States Preventive Services Task Force (USPSTF) criteria for LDCT (age 50-80 and \\>= 20 pack-years smoking) or high-risk but not meeting USPSTF (age 45-49 and \\>= 20 pack-years smoking)\n* Possession of a smartphone that can support Positively Smoke Free Mobile (PSF-M) (\\> 95% of subjects had eligible phones in prior trials although researchers will include specific study screening questions assessing for adequate smartphone for the intervention)\n* Sufficient literacy; \\>= 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-R) literacy scale\n\nExclusion Criteria:\n\n* Receiving any other smoking cessation interventions currently or within the prior 30 days\n* Contraindication to nicotine replacement therapy\n* Pneumonia or serious lung infection in prior 12 weeks\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active major infection, malignant tumors (unless these tumors were: (a) completely resected basal cell or squamous cell skin carcinomas or (b) in-situ squamous cell carcinoma of the cervix or anus), or any other major uncontrolled comorbid condition that would limit life expectancy or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* History of lung cancer\n* Pregnant women are excluded from this study because computed tomography introduces radiation exposure and may have teratogenic effects\n* Women who are breastfeeding (the safety of nicotine replacement therapy has not been established with breastfeeding)\n* Received a chest computed tomography scan in the previous twelve months","45 Years","80 Years",{"count":49,"type":20},100,[51],"NA","This clinical trial evaluates the usefulness of using a smartphone-based HIV-specific smoking cessation intervention at the time of lung cancer screening in helping people living with HIV quit smoking. Positively Smoke Free - Mobile may help patients with HIV quit smoking.",[54,55],"HIV Infection","Tobacco-Related Carcinoma","RECRUITING","2026-06-04",{"date":59,"type":31},"2026-06-05",{"date":61,"type":31},"2023-03-22",{"date":63,"type":20},"2027-08-31",{"name":37,"class":38},11,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"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":74,"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.",[78,79,54,80,81,82,83,84,85,86,87,88],"Anal Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Kaposi Sarcoma","Lymphoma","Malignant Solid Neoplasm","Multicentric Castleman Disease","Plasmablastic Lymphoma","Recurrent Kaposi Sarcoma","Recurrent Lymphoma","Recurrent Plasmablastic Lymphoma","Transplant-Related Kaposi Sarcoma","2026-05-28",{"date":91,"type":31},"2026-06-01",{"date":93,"type":31},"2023-05-10",{"date":95,"type":20},"2035-08-31",{"name":37,"class":38},8,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":97},"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":106,"type":20},15,[108],"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.",[84,111,112,113,114],"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":91,"type":31},{"date":117,"type":31},"2021-05-24",{"date":119,"type":20},"2030-07",{"name":37,"class":38},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":138,"leadSponsor":140,"locationsCount":39},"100634420","phase-2-nirogacestat-in-patients-with-kaposi-sarcoma-100634420","NCT07539454","Nirogacestat in Patients With Kaposi Sarcoma","Phase II Study of Nirogacestat in Patients With Kaposi Sarcoma","Inclusion Criteria:\n\n* Biopsy-proven KS involving skin with or without visceral involvement either newly diagnosed or refractory to or intolerant of one or more prior therapies.\n* Patients must have cutaneous lesion(s) amenable to six total biopsies (minimum size of biopsy to be 4 mm), either six lesions \\> 4 mm or one large lesion measuring 20 mm that can undergo serial biopsy, and at least five additional lesions measurable for assessment with no improvement over the past month.\n* Hemoglobin ≥ 8 g\u002FdL (within three months prior to study entry)\n* Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm\\^3 (within three months prior to study entry)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (within three months prior to study entry)\n* Calculated (method of Cockcroft-Gault) creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (within three months prior to study entry) (CrCl may also be obtained by the 24-hour collection method at the investigator's discretion)\n* Total bilirubin should be ≤ 1.5x upper limit of normal (ULN) (within three months prior to study entry). If, however, the elevated bilirubin is felt to be secondary to atazanavir therapy, patients will be allowed to enroll on protocol if the total bilirubin is ≤ 3.5 mg\u002FdL provided that the direct bilirubin is normal\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \\[SGPT\\]) ≤ 3x ULN (within three months prior to study entry)\n* Life expectancy ≥ 3 months.\n* Ability and willingness to give informed consent.\n* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test defined as serum Estradiol (E2) \\> 30 pg\u002FmL, a serum follicle stimulating hormone (FSH) \\\u003C 40 mIU\u002FL (measured on Day 3 in regularly menstruating females and age-matched), within 10-14 days prior and again within 24 hours of starting nirogacestat. FCBP must either commit to continued abstinence from heterosexual intercourse or the use of two acceptable methods of birth control, one highly effective method except oral contraceptives and one additional effective method at the same time , at the start of therapy to 7 days after discontinuation of nirogacestat, inclusive. Females and males of reproductive potential will be advised to use effective contraception during treatment with nirogacestat and for 7 days after the last dose. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Patients must, in the opinion of the investigator, be capable of complying with the protocol.\n\n  * A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n* All patients with HIV must be on antiretroviral therapy (ART) for HIV infection with CD4 count \\> 50\u002Fmm\\^3 and viral load \\\u003C 200 copies\u002FmL. Patients must be on a stable regimen for at least 12 weeks prior to study entry. Patients may receive any Food and Drug Administration (FDA) approved ART except for zidovudine or protease inhibitors.\n* There should be no evidence for improvement in KS in the 3 months prior to study entry for all participants, unless there is evidence for progression of KS in the 4 weeks immediately prior to study entry.\n* If antiretroviral regimen contains zidovudine, efavirenz, etravirine, or protease inhibitors and viral load is suppressed (as measured by HIV viral load ≤ 200\u002FmL), then ART must be adjusted to a less toxic therapy not containing these antivirals and enrollment may proceed without waiting 12 weeks. If on antiviral therapy with zidovudine, efavirenz, etravirine, or protease inhibitors, and viral load is not suppressed (as measured by HIV viral load ≥ 200\u002FmL), then ART must be adjusted to a less toxic regimen allowing for optimal viral suppression and must demonstrate stability for at least 12 weeks prior to study entry.\n* If HIV positive, documentation of HIV-1 or HIV-2 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 demonstrating \\> 200 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 an HIV-1 Western blot confirmation or HIV rapid multi-spot antibody differentiation assay.\n* Age ≥ 18 years. No dosing or adverse event (AE) data are currently available on the use of nirogacestat in participants \\\u003C 18 years of age; children are excluded from this study.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).\n* Participants 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 within 3 months before study enrollment. To be eligible for this trial, participants must be Class II or better within 3 weeks before enrollment.\n\nExclusion Criteria:\n\n* Concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment.\n* Patients for whom front-line cytotoxic therapy is indicated (i.e., symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status).\n* Concurrent neoplasia requiring cytotoxic therapy.\n* Anti-neoplastic treatment for KS (including chemotherapy, radiation therapy, local therapy including topical 5-FU, biological therapy, or investigational therapy) within four weeks of study entry.\n* Any ongoing glucocorticoid treatment (within last three months, lasting longer than 14 days) except for that required for replacement therapy in adrenal insufficiency or inhaled glucocorticoids for the treatment of asthma.\n* Any steroid treatment with equivalent of more than 10 mg prednisone\u002Fday lasting longer than 14 days in the last 3 months.\n* Patient is ≤ 2 years free of another primary malignancy. Exceptions include the following:\n\n  * Basal cell skin cancer.\n  * Cervical carcinoma in situ.\n  * Anal carcinoma in situ.\n* Previous local therapy of any KS-indicator lesion unless the lesion has clearly progressed since treatment. Any prior local treatment to indicator lesions regardless of the elapsed time should not be allowed unless there is evidence of clear-cut progression of said lesion.\n* Use of any investigational drug or treatment within four weeks prior to enrollment.\n* Physical or psychiatric conditions that in the estimation of the investigator place the patient at high risk of toxicity or non-compliance.\n* Female patients who are pregnant, lactating, or breast-feeding.\n* Patients requiring blood transfusions to maintain hemoglobin eligibility.\n* Patients currently receiving zidovudine, protease inhibitors, efavirenz, etravirine, ketoconazole, itraconazole, erythromycin, clarithromycin, dexamethasone, phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, St John's Wort, tacrolimus, cyclosporine, oral contraceptives, warfarin, docetaxel, sirolimus, or other inhibitors or inducers of CYP3A4 or substrates of CYP3A4 that have a narrow therapeutic margin.\n* Patients with CD4 \\\u003C 50 mm\\^3 and\u002For viral load ≥ 200 copies\u002FmL.\n* HIV+ patients with corrected QT interval by Fridericia's formula (QTcF) \\> 480 ms.",{"count":129,"type":20},28,[23],"This phase II trial studies how well nirogacestat works in treating patients with skin Kaposi sarcoma (KS). Several anti-cancer drugs work well in treating KS, but there is no treatment that cures KS. Nirogacestat binds to a protein called gamma secretase, which blocks the activation of other proteins called Notch receptors. Blocking these proteins may help keep tumor cells from growing and may kill them. Nirogacestat is a type of gamma secretase inhibitor. Nirogacestat may be effective in shrinking the size of KS lesions and reducing the spread of lesions.",[133,134],"AIDS-Related Kaposi Sarcoma","Skin Kaposi Sarcoma","2026-05-27",{"date":89,"type":31},{"date":33,"type":20},{"date":139,"type":20},"2030-02-17",{"name":37,"class":38},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"100445214","phase-1-immune-cell-therapy-car-t-for-the-treatment-of-patients-with-hiv-and-b-cell-non-hodgkin-lymphoma-100445214","NCT05077527","Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma","Axicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Participant with age \\>= 18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of axicabtagene ciloleucel in participants \\\u003C 18 years of age, children are excluded from this study\n* Participant is able to understand and willing to sign a written informed consent document before any study procedures\n* Participant must have R\u002FR aggressive B-cell NHL of the following histologies:\n\n  * Diffuse large B-cell lymphoma (DLBCL, including transformed from indolent histology)\n  * High-grade B-cell lymphoma\n  * Primary mediastinal B-cell lymphoma\n  * Follicular lymphoma, grade 3B\n* Participant must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have R\u002FR disease after at least 2 lines of therapy\n\n  * At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent\n* Evaluable disease as either:\n\n  * Positron emission tomography (PET)-positive disease according to the \"Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\", or\n  * Bone marrow involvement assessed by bone marrow biopsy\n* Eastern Cooperative Oncology Group ECOG performance status =\\\u003C 1 (Karnofsky \\>= 60%)\n* Serum creatinine =\\\u003C 1.5 x age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft and Gault) \\> 30 mL\u002Fmin\u002F1.73 m\\^2 (within 4 weeks before enrollment)\n* Alanine aminotransferase (ALT) =\\\u003C 5 x ULN and total bilirubin \\\u003C 2.0 mg\u002FdL (or \\\u003C 3.0 mg\u002FdL for subjects with Gilbert's syndrome or lymphomatous infiltration of the liver or if taking atazanavir or indinavir (within 4 weeks before enrollment)\n* Adequate pulmonary function, defined as =\\\u003C Common Terminology Criteria for Adverse Events (CTCAE) grade 1 dyspnea and oxygen saturation (SaO2) \\>= 92% on room air (within 4 weeks before enrollment)\n* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \\>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) scan performed within 1 month of determination of eligibility\n* Absolute neutrophil count: \\>= 1,000\u002Fmm\\^3 (within 4 weeks before enrollment)\n* Platelets: \\>= 75,000\u002Fmm\\^3 (within 4 weeks before enrollment)\n* Total bilirubin: =\\\u003C 1.5 x institutional upper limit of normal (ULN) (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 ALT =\\\u003C 3 x the upper limit of normal (within 4 weeks before enrollment)\n* Adequate vascular access for leukapheresis procedure and for administration of the cellular product (either peripheral line or leukapheresis catheter)\n* Participants who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy\n* The effects of axicabtagene ciloleucel on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry, for the duration of study participation, and 12 months after the last dose of axicabtagene ciloleucel. 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\n* Men who have partners of childbearing potential must agree to use an effective barrier contraceptive method before study entry, for the duration of study participation, and for 1 year after the last dose of axicabtagene ciloleucel\n* 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 investigator;\n  * Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \\[PrEP\\]) by a licensed health care investigator. 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 demonstrating \\>1000 RNA copies\u002FmL;\n\n    * Any federally approved, 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. 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* HIV viral load below 50 copies\u002FmL by FDA-approved assays within 4 weeks prior to registration\n* A CD4 cell count must be obtained within 4 weeks before enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent. Twenty participants will be studied with a goal to enroll a minimum of 6 participants with a CD4 \\\u003C100 cells\u002FuL\n* Participants who have hepatitis C (reactive anti-HCV antibody) and hepatitis B (HBsAg positive and\u002For anti-HBc-Total positive), may be enrolled, provided total bilirubin is =\\\u003C 1.5 x institutional upper limit of normal (ULN), AST (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and ALT (serum glutamic pyruvic transaminase \\[SGPT\\]) must be =\\\u003C 3 X institutional upper limit of normal, and HBV deoxyribonucleic acid (DNA) \\\u003C100 IU\u002FmL (if hepatitis B positive) within 4 weeks before enrollment. There must be no evidence of cirrhosis present\n* Participants with hepatitis B core antibody positive must be on an antiviral agent to suppress hepatitis B throughout the study and be willing to continue therapy for at least one year after axicabtagene infusion\n* Participants who are willing to continue ART during leukapheresis, manufacturing and infusion and post infusion of axicabtagene ciloleucel\n\nExclusion Criteria:\n\n* Participants felt to have a high prospect of clinically benefiting from autologous transplantation\n* Participants with central nervous system (CNS)-only involvement by malignancy (note: participants with secondary CNS involvement are allowed on study\n* Participants with a second prior or concurrent malignancy that, in the opinion of the investigator, has a natural history or treatment course that has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Treatment with alemtuzumab within 6 months before anticipated leukapheresis, or treatment with fludarabine or cladribine within 3 months before anticipated leukapheresis\n* Participants with uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate antibiotics or other treatment at the time of enrollment\n* Presence of acute or chronic graft-versus-host disease\n* History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease\n* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis\n* Pregnant or nursing women. NOTE: Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours before starting conditioning chemotherapy. Pregnant women are excluded from this study because axicabtagene ciloleucel has not been studied in pregnant women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with axicabtagene ciloleucel, breastfeeding should be discontinued if the mother is treated with axicabtagene ciloleucel. These potential risks may also apply to other agents used in this study\n* Use of the following:\n\n  * Therapeutic doses of corticosteroids (defined as \\> 20 mg\u002Fday prednisone or equivalent) within 7 days before leukapheresis or 72 hours before axicabtagene ciloleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted\n  * Chemotherapy given after leukapheresis to maintain disease control must be stopped \\>= 7 days before conditioning chemotherapy\n  * Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week before leukapheresis. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to leukapheresis\n  * Lymphotoxic chemotherapeutic agents (e.g., cyclophosphamide, ifosfamide, bendamustine) within 2 weeks before leukapheresis\n  * Experimental agents received within 4 weeks before leukapheresis unless no response or disease progression is documented while on the experimental therapy and at least 3 half-lives have elapsed before leukapheresis\n  * Immunosuppressive therapies within 4 weeks before leukapheresis and axicabtagene ciloleucel administration (e.g., calcineurin inhibitors, methotrexate, or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL6, or anti-IL6R)\n  * Donor lymphocyte infusions (DLI) within 6 weeks before axicabtagene ciloleucel administration\n  * Radiation within 1 week before leukapheresis. Subjects must have progressive disease in irradiated lesions or have additional non-irradiated, PET-positive lesions to be eligible. However, palliative radiation to a single lesion, if additional non-irradiated PET-positive lesions are present, is allowed up to 2 weeks before leukapheresis\n  * Prior receipt of CAR T-cell therapy\n* Participants with signs or symptoms indicative of active CNS involvement are excluded from the protocol, with the following exceptions: The following patients are included in the protocol:\n\n  * Participants with previously treated CNS involvement by lymphoma or leukemia, who and have no neurologic symptoms and no evidence of active lymphoma or leukemia in the CNS by total spine and brain gadolinium enhanced magnetic resonance imaging (MRI) within 2 weeks before leukapheresis and no neurologic progression prior to axicabtagene ciloleucel (axi-cel) infusion\n  * Participants with active CNS involvement and stable neurologic symptoms for at least 3 weeks before leukapheresis and without neurologic progression prior to axi-cel infusion. These patients should have assessment by a total spine and brain gadolinium enhanced MRI within 5 days before axi-cel infusion to document the extent of CNS disease prior to axi-cel infusion. Cerebrospinal fluid (CSF) sampling for cell count, cytology and cell markers by flow cytometry should also be included within 5 days of axi-cel infusion if previously positive\n* Inhaled or topical steroids and adrenal replacement doses =\\\u003C 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, including if \\>= 10 mg\u002Fday prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted. Use of anabolic steroids is permitted\n* The participant has not recovered to baseline or CTCAE =\\\u003C grade 1 from toxicity due to all prior therapies except =\\\u003C grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs), provided that all other eligibility criteria are met\n* Opportunistic infection within the last 3 months, with the exception of oropharyngeal candidiasis\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to axicabtagene ciloleucel or other agents used in study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness with potential to limit compliance with study requirements",{"count":149,"type":20},20,[151],"PHASE1","This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.",[154,155,54,156,157,158,159,160,161,162,163,164,165,166,167],"AIDS-Related Diffuse Large B-cell Lymphoma","AIDS-Related Non-Hodgkin Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Grade 3b Follicular Lymphoma","Recurrent High Grade B-Cell Lymphoma","Recurrent Non-Hodgkin Lymphoma","Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Recurrent Transformed B-Cell Non-Hodgkin Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Grade 3b Follicular Lymphoma","Refractory High Grade B-Cell Lymphoma","Refractory Non-Hodgkin Lymphoma","Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Refractory Transformed B-Cell Non-Hodgkin Lymphoma","2026-04-09",{"date":170,"type":31},"2026-04-14",{"date":172,"type":31},"2025-02-13",{"date":174,"type":20},"2029-01-31",{"name":37,"class":38},6,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":39},"100416590","feasibility-study-of-ocular-surface-squamous-neoplasia-surgical-excision-in-people-living-with-hiv-in-sub-saharan-africa-100416590","NCT04704648","Feasibility Study of Ocular Surface Squamous Neoplasia Surgical Excision in People Living With HIV in Sub-Saharan Africa","Feasibility Study of Ocular Surface Squamous Neoplasia (OSSN) Surgical Excision in People Living With HIV in Sub-Saharan Africa (SSA)","Inclusion Criteria:\n\n3.2.1 Participants with suspected unilateral, non-invasive OSSN lesions that the AMC-certified ophthalmologist determines can be resected with 3 mm clinical margins, sparing involvement of the superior and inferior fornices as well as 6 clock hours of the corneal scleral limbus. This assessment must be carried out within 4 weeks before surgery.\n\n3.2.2 HIV positive. Documentation of HIV-1 infection by means of any one of the following:\n\n* Documentation of receipt of 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. Antiretroviral drug regimens used for pre-exposure prophylaxis (PrEP) may not satisfy this requirement.;\n* HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \\>1000 RNA copies\u002FmL confirmed by a licensed screening antibody and\u002For HIV antibody\u002Fantigen combination assay;\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\nNote: 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., U.S. FDA).\n\nWHO and CDC (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 enzyme or chemiluminescence assay (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\n3.2.3 Performance status ≤ 2 on the WHO Scale (see Appendix III).\n\nExclusion Criteria:\n\n3.3.1 Participants who are receiving any other investigational agents within 30 days before enrollment for surgery, except for investigational ART regimens, which will be permitted.\n\n3.3.2 Participants with known history of ocular surface lesions including OSSN, other ocular neoplasm, pterygia, or limbal vernal keratoconjunctivitis.\n\n3.3.3 Uncontrolled intercurrent illness within 4 weeks before enrollment, including but not limited to ongoing or active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":185,"type":20},84,[51],"Participants will undergo surgical excision of OSSN at baseline and will be followed at 1 week, 6 weeks, 6 months, and 12 months for post-surgical follow up. This study is being conduced to assess the feasibility of conducting multi-center prospective studies on surgical excision of suspected OSSN lesions in SSA in people living with HIV\u002FAIDS (PLWHA). Participants include those with HIV infection and with suspected non-invasive OSSN lesions that the AMC-certified ophthalmologist determines can be resected with 3 mm clinical margins, sparing involvement of the superior and inferior fornices and 6 clock hours of the corneal scleral limbus.",[189,190],"Ocular Surface Squamous Neoplasia","HPV","2026-03-19",{"date":193,"type":31},"2026-03-23",{"date":195,"type":31},"2023-06-21",{"date":197,"type":20},"2027-12-30",{"name":37,"class":38},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":65},"100385974","phase-2-trial-of-ixazomib-for-kaposi-sarcoma-100385974","NCT04305691","Trial of Ixazomib for Kaposi Sarcoma","A Phase 2 Trial of Ixazomib for Kaposi Sarcoma","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Participants must have histologically or cytologically confirmed cutaneous Kaposi sarcoma. Participants must have measurable disease with a minimum of five bi-dimensionally measurable KS cutaneous marker lesions. If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be \\>= 700 mm\\^2\n* Participants must have documentation of HIV status. If HIV negative, documentation of a negative HIV rapid test within 21 days before enrollment. If HIV positive, 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 antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre exposure prophylaxis \\[PrEP\\]) 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 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 Multispot HIV-1\u002FHIV-2 Rapid Test or HIV Antibody HIV-1\u002FHIV-2 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 \\[U.S.\\] Food and Drug Administration \\[FDA\\]). WHO (World Health Organization) and CDC (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 extracellular interactome assay (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* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 50%)\n* Life expectancy of greater than 3 months\n* Absolute neutrophil count: \\>= 1,000\u002Fmm\\^3 (within 21 days before enrollment)\n* Hemoglobin: \\> 8 g\u002FdL (within 21 days before enrollment)\n* Platelets: \\>= 75,000\u002Fmm\\^3 (within 21 days before enrollment). Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before study enrollment\n* Total bilirubin =\\\u003C 1.5 x the upper limit of the normal range (ULN) (within 21 days before enrollment)\n\n  * If the elevated bilirubin is felt to be secondary to indinavir or atazanavir therapy, then subjects will be allowed on protocol without any limit on the total bilirubin if the direct bilirubin is normal\n* Creatinine:\n\n  * Serum creatinine levels within normal institutional limits; or, creatinine clearance \\>= 30 mL\u002Fmin (as calculated per the Cockcroft-Gault Equation (within 21 days before enrollment)\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification within 6 months before study enrollment. To be eligible for this trial, participants must be class 2B or better within 6 months before enrollment\n* Ixazomib can cause fetal harm. For this reason and because proteasome inhibitors 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 (barrier method of birth control and another method such as hormone contraception simultaneously; abstinence) before study entry, the duration of study participation, and 90 days after completion of ixazomib administration. 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 treated or enrolled on this protocol must also agree to use adequate contraception or abstain from heterosexual contact before the study, for the duration of study participation, and for 90 days after completion of ixazomib administration\n* If HIV positive, participants must have been on antiretroviral therapy (ART) with optimum anti-viral response for at least 12 weeks. Three-drug ART regimens which include a protease inhibitor or a nucleoside reverse transcriptase inhibitor are acceptable, as is the recently FDA-approved injectable ART regimen, cabotegravir with rilpivirine. Additional appropriate regimens in management of HIV as specified in https:\u002F\u002Fclinicalinfo.hiv.gov\u002F are acceptable as long as they do not include moderate or strong CYP3A4 inducers. Changes of antiretroviral therapy within the prior 12 weeks for toxicity\u002Fconvenience reasons are allowed (as long as participants are on a stable regimen for 4 weeks per Section 3.1.11). However, if changes in anti-HIV therapy are due to inadequate HIV control and occurred within the 3 months prior to protocol consent, the patient is not eligible until 12 weeks after optimal control is reached.\n* If HIV positive, must have been on a STABLE anti-retroviral therapy for at least 4 weeks. The non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz and etravirine are moderate CYP3A4 inducers which will reduce ixazomib exposure and are therefore prohibited. Potential participants requiring change of antiretroviral therapy to avoid moderate to strong CYP3A4 inducers or to pursue better HIV management with an alternate antiretroviral regimen should defer enrollment until completing 4 weeks of the new ART regimen. There should be no intention to change the regimen for the duration of the study.\n* HIV positive participants must not show recent improvement in KS on ART alone that may confound response evaluation, within the following parameters:\n\n  * If on ART 12 to 24 weeks, participants must show a burden of disease requiring further systemic KS-directed treatment (i.e. advanced cutaneous disease, presence of lymphedema or asymptomatic visceral disease, painful lesions) or evidence of KS progression:\n  * i.e. any new lesion(s);\n  * spreading of lesions by any measurable degree;\n  * development of ulceration;\n  * worsening edema documented by circumferential measure of limb or body;\n  * increase in symptoms such as pain, including negative psychological impact;\n  * any degree of disease worsening by imaging that would prompt expert assessment to recommend further systemic treatment with delay\n  * If on ART for \\>24 weeks, must show no evidence of regression in last 8 weeks\n* Patients who have residual active KS lesions (not merely tattoo effect) after receipt of recent KS-directed therapy are eligible to participate even if there was no interval progression since completion of therapy as long as: (1) the degree of residual disease merits systemic therapy (i.e. advanced cutaneous disease, presence of lymphedema or asymptomatic visceral disease, painful lesions)); and (2) at least 4 weeks have passed since receipt of the most recent KS-directed therapy.\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixazomib or other agents used in study\n* Chronic systemic treatment using strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort is not allowed. Patients who are on chronic use of strong CYP3A inducers must come off 14 days before receiving ixazomib treatment. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months; or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. This includes infections requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment but excludes ongoing antibiotic therapy for opportunistic infection (OI) prophylaxis\n* Participants with a second prior or concurrent malignancy that has a natural history or treatment regimen that has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Pregnant women are excluded from this study because ixazomib is expected to cause fetal harm if used during pregnancy. It is not known if ixazomib is excreted into breast milk, but due to the potential for serious adverse events in a nursing infant, breastfeeding must be discontinued during therapy and for 90 days after the last ixazomib dose\n* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before entering the study\n* Participants who have not recovered from other adverse events due to prior anti-cancer therapy (i.e., have residual toxicity \\> grade 1), excluding alopecia\n* Participants 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 deoxyribonucleic acid (DNA) levels. Participants who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of hepatitis B virus (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\n* Participants 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 that conform to the protocol inclusion criteria\n* Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing\n* Participants with grade 2 or higher peripheral neuropathy (i.e., painful neuropathy) on clinical examination during the screening period\n* Major surgery within 14 days before enrollment\n* Participants with symptomatic visceral Kaposi sarcoma\n* Participants who have had prior treatment of Kaposi sarcoma with a proteasome inhibitor within the last 2 years or with ixazomib at any time.",{"count":207,"type":20},41,[23],"This phase II trial studies how well ixazomib works in treating patients with Kaposi sarcoma. Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.",[80,211],"Skin",[80,213,211,214],"HIV","ixazomib","2026-02-25",{"date":217,"type":31},"2026-02-27",{"date":219,"type":31},"2023-11-07",{"date":221,"type":20},"2029-03-15",{"name":37,"class":38},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},"100500546","phase-2-a-study-of-propranolol-to-treat-kaposi-sarcoma-100500546","NCT05797662","A Study of Propranolol to Treat Kaposi Sarcoma","A Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Children and Adults","Inclusion Criteria:\n\n* Pediatric (\\\u003C 18 years) and adult (≥ 18 years) participants with biopsy-proven and measurable Kaposi Sarcoma (KS) as defined in the KS Manual of Procedures (MOP).\n* No urgent clinical indication for immediate cytotoxic chemotherapy. Participants who have received cytotoxic chemotherapy \\> 4 weeks prior to screening are eligible.\n* KS stage:\n\n  * \\\u003C 18 years:\n\n    * 1A (Mild): disease limited to skin, flat oral mucosal lesions, and\u002For flesh colored subcutaneous nodules, total \\\u003C10 lesions.\n    * 1B (Moderate): having any of the following features, alone or in combination: a total of 10-19 hyperpigmented skin\u002Foral lesions, nodular oral involvement, conjunctival eye involvement, or exophytic mass.\n  * ≥ 18 years:\n\n    * T0: confined to skin and\u002For lymph nodes and\u002For minimal oral lesions.\n    * T1: limited to tumor-associated edema of cutaneous lesions without functional impairment or flat oral lesions.\n* Performance Status:\n\n  * \\\u003C 18 years:\n\n    * Lansky performance status \\> 70%\n  * ≥ 18 years:\n\n    * Easter Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participants must have adequate organ function, as defined by the following:\n\n  * Bilirubin (direct or total) within normal range, or total bilirubin \\\u003C3.0 mg\u002Fdl for participants with Gilbert syndrome.\n  * Calculated creatinine clearance ≥ 30 mL\u002Fmin for participants ≥ 12 years (see Appendix III); creatinine \\\u003C1.5 Upper Limit Normal (ULN) for participants \\\u003C 12 years.\n  * Hemoglobin \\> 9 g\u002FdL;\n  * Platelets \\> 100 × 109\u002FL;\n  * ANC \\> 1000 cells\u002Fmm3\n* Human Immunodeficiency Virus (HIV) positive participants must be on antiretroviral therapy (ART) that conforms to local standards of care. Participants will have been on ART for at least 12 weeks. Participants will not be excluded based on CD4 count or HIV viral load.\n* HIV positive participants must not show recent improvement on ART that may confound response evaluation:\n\n  * If on ART 12 to 24 weeks, participants must show evidence of KS progression requiring further systemic treatment.\n  * If on ART for \\>24 weeks, must show no evidence of regression in the last eight weeks.\n* HIV-negative participants must not show evidence of improvement in the three months prior to enrollment.\n* No history of asthma or diabetes mellitus (as it is a risk factor for hypoglycemia).\n* No clinically significant cardiovascular disease other than hypertension, which is permitted.\n* No use of beta-adrenergic antagonists for other indications.\n* Not pregnant or planning to become pregnant. Propranolol is United Stats Food and Drug Administration (US FDA) pregnancy category C. At this time, the study team has determined that the unknown risk to a developing fetus is greater than the potential benefit of treatment.\n* Use of effective contraception for women of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months.\n* Women of child bearing potential (WOCBP) must agree to use adequate contraception (oral contraceptive pills, intrauterine device, Nexplanon, Depo-Provera, or permanent sterilization, etc., or another acceptable method as determined by the investigator) prior to study entry, for the duration of study participation.\n* Not breast feeding.\n\nExclusion Criteria:\n\n• Participants who do not fulfill the criteria as listed in Section 3.1 above, are ineligible. Additionally, the presence of any of the following conditions will exclude a participant from study enrollment:\n\n* Children and adolescents with lymph node or visceral disease, woody edema, or ≥ 20 cutaneous lesions.\n* Children and adolescents with heart rate or systolic blood pressure \\\u003C10th percentile for age.\n* Adults with visceral disease or tumor-associated edema causing functional impairment.\n* Shortness of breath, hemoptysis, or moderate\u002Fsevere cough not attributable to causes other than KS.\n* Bleeding from the mouth or rectum not attributable to causes other than KS.\n* Treatment for active and serious infection.\n* Children with severe acute malnutrition based on World Health Organization (WHO) criteria (Mid-upper arm circumference \\\u003C11.5 cm, weight-for height Z-score \\\u003C-3 or presence of symmetrical pitting edema).\n* Given the risk of hypotension and hypoglycemia, participants must take the study drug with food. If needed, the study team will pursue additional funding to support providing supplemental food for participants who experience food insecurity.\n* Patients who experienced hypersensitivity to propranolol during initiation phase of treatment or had previous known allergy to propranolol or allergy to other β-blockers.\n* Patients with a history of uncompensated heart failure; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree.\n* Patients with diagnosed obstructive airway disease such as asthma, chronic obstructive pulmonary disease (COPD), or bronchiolitis.\n* History of diabetes mellitus (as it is a risk factor for hypoglycemia)\n* Patients receiving concurrent treatment with an anticancer therapy. Patients must not have received any anticancer therapies within 30 days prior to receiving the first dose of investigational treatment.\n* Patients with concern for Kaposi Sarcoma herpesvirus (KSHV) inflammatory cytokine syndrome.",{"count":231,"type":20},25,[23],"A clinical study of propranolol for the treatment of Kaposi Sarcoma in children and adults. This study will be an open-label single armed treatment trial that will test the effectiveness and the safety of treating Kaposi Sarcoma with propranolol.",[80],[80,236],"Propranolol","2026-01-22",{"date":239,"type":31},"2026-01-23",{"date":241,"type":20},"2026-09",{"date":243,"type":20},"2029-04",{"name":37,"class":38},9,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":21,"phases":255,"briefSummary":257,"conditions":258,"keywords":261,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":269,"leadSponsor":271,"locationsCount":4},"100470851","phase-3-paclitaxel-and-pegylated-liposomal-doxorubicin-for-treatment-of-hiv-related-kaposi-sarcoma-100470851","NCT05411237","Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma","A Phase III, Randomized, Open-Label, Non-Inferiority Study of Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma in Resource-Limited Settings","Inclusion Criteria:\n\n1. HIV-1 infection.\n2. Histologically confirmed KS at any time prior to study entry, confirmed by an AIDS Malignancy Consortium (AMC)-certified pathologist.\n3. Current stage T1 KS (irrespective of prior treatment with antiretroviral therapy (ART) OR\n\n   Stage T0 KS that has progressed or not responded after a minimum of 12 weeks of treatment with ART. Participants with T0 KS must have either:\n   * 20 or more skin and\u002For oral KS lesions, and\u002For\n   * any number of lesions on exposed body areas that have an adverse effect on quality of life (e.g., stigmatization).\n4. Men and women ≥ 18 years. Because no dosing or adverse event data are currently available on the use of PTX or PLD for AIDS-KS in persons \\\u003C18 years of age, children are excluded from this study\n5. Karnofsky performance status ≥ 60 (ECOG ≤ 2).\n6. Echocardiogram or Multiple gated acquisition scanning (MUGA) showing an ejection fraction ≥ 50%.\n7. Ability and willingness of participant or legal guardian to provide informed consent.\n8. Participants may be ART-naïve or ART-experienced but must be able to receive an ART regimen considered likely to result in HIV suppression.\n9. Measurable cutaneous KS, defined as follows:\n\n   * When available, a minimum of five bi-dimensionally measurable KS cutaneous marker lesions.\n   * If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be ≥ 700mm2.\n10. The following laboratory values obtained within 14 days prior to study entry:\n\n    * Absolute Neutrophil Count ≥ 1000 cells\u002Fmm3.\n    * Hemoglobin ≥ 8 g\u002FdL (may be achieved with transfusion if clinically indicated, in the opinion of the investigator).\n    * Platelet count ≥ 75,000\u002Fmm3.\n    * ALT, AST, Alkaline phosphatase \\\u003C 5 × upper limit of normal (ULN).\n    * Total bilirubin: ≤ 1.5 × ULN, unless the participant is receiving an antiretroviral drug known to be associated with increased bilirubin, in which case the direct fraction should be ≤ 2 x the ULN.\n    * Creatinine \\\u003C institutional ULN OR estimated glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n11. Women of reproductive potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months), must have a negative pregnancy test done within 24 hours of initiating the protocol-specified chemotherapy medication.\n12. Participants must agree to use two reliable forms of contraception simultaneously while receiving study protocol-specified medication and for 6 months after stopping the medication.\n13. Adequate venous access.\n14. No prior chemotherapy or use of systemic cytotoxic therapy agents.\n15. Participant is able to understand and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Current acute, chronic, or recurrent infections that are serious, in the opinion of the site investigator, for which the participant has not completed at least 14 days of therapy before study entry and\u002For is not clinically stable.\n2. Serious illness necessitating hospitalization\u002Fsystemic treatment within 14 days prior to study entry\n3. Breastfeeding or pregnant women are excluded because of potential risks of cytotoxic chemotherapy to an unborn child or infant.\n4. Known history of congestive heart failure and\u002For systolic ejection fraction \\\u003C 50%.\n5. Prior radiotherapy to KS indicator lesions\n6. Prior or current immunotherapy\n7. Any immunomodulator, HIV vaccine, live attenuated vaccine, other investigational vaccine within 30 days prior to study entry, excluding vaccines against COVID-19\u002FSARS-CoV-2, which are permitted.\n8. Known allergy\u002Fhypersensitivity to the study drug or its formulation\n9. Any condition, including the presence of laboratory abnormalities, which in the opinion of the responsible investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.\n10. Corticosteroid use at doses above those given for replacement therapy for adrenal insufficiency within the last 30 days prior to study entry.\n11. Patients with psychiatric illness and\u002For social circumstances that would limit compliance with study requirements.",{"count":254,"type":20},130,[256],"PHASE3","This study is being done to determine if two different anti-cancer drugs, paclitaxel (PTX) and pegylated liposomal doxorubicin (PLD) have similar effects on treating Kaposi Sarcoma (KS) in people living with HIV (human immunodeficiency virus) in sub-Saharan Africa. Patients with HIV-related KS will receive either PTX or PLD once every 3 weeks for a total of six cycles.",[80,259,260],"HIV-1-infection","AIDS-related Kaposi Sarcoma",[262,263,264,265,266],"Paclitaxel","Pegylated liposomal doxorubicin","AIDS associated Kaposi Sarcoma","Human Immunodeficiency Virus","HIV-related Kaposi Sarcoma",{"date":239,"type":31},{"date":241,"type":20},{"date":270,"type":20},"2030-09",{"name":37,"class":38},""]