[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cytokine-release-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cytokine-release-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,71,99,124,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100550461","phase-1-study-of-cytokine-release-syndrome-prophylaxis-and-treatment-with-siltuximab-prior-to-epcoritamab-100550461",false,"NCT06447376","Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab","Pilot Safety-feasibility Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab","Inclusion Criteria:\n\n* Adults 18 years of age and older\n* Diagnosis of non-Hodgkin lymphoma.\n\n  * DLBCL (including high grade B cell lymphoma and follicular lymphoma grade 3B and transformed follicular lymphoma) treated with at least 2 lines of systemic antineoplastic therapies, including at least 1 anti-CD20 monoclonal antibody - containing therapy\n  * FL grade 1-3A previously treated with at least 2 lines of systemic antineoplastic therapy, including at least 1 anti-CD20 monoclonal antibody - containing therapy.\n* At least 1 risk factor for cytokine release syndrome, including:\n\n  * Age ≥ 65 years,\n  * Elevated lactate dehydrogenase,\n  * White blood cell count pre-anti-CD20 treatment \\> 4.5x109 cells\u002FL,\n  * Ann Arbor Stage III\u002FIV,\n  * Sum of the product of the perpendicular diameters at study entry ≥3000mm2,\n  * Cardiac comorbidity, including prior coronary disease, heart failure and other conditions that in the opinion of the investigator would increase the risk of heightened toxicity from CRS\n  * Bone marrow infiltration,\n  * Circulating lymphoma cells in peripheral blood\n* Adequate bone marrow function including:\n\n  * Hemoglobin ≥ 8g\u002FdL (unless bone marrow involvement by lymphoma) (transfusion allowed for symptomatic participants),\n  * Absolute neutrophil count cell count ≥1000 \u002F μL, with or without growth factor support\n  * Platelet counts ≥ 75,000 \u002F μL (unless bone marrow involvement by lymphoma, in which case platelet counts ≥ 50,000 \u002F µL are required)\n* ECOG performance status 0 - 2\n* Adequate renal function, defined as an estimated creatinine clearance ≥ 30 mL\u002Fmin.\n\n  * NOTE: Participants who will receive the addition of GemOx in cycle 2 must continue to exhibit an estimated creatinine clearance of ≥ 30 mL\u002Fmin prior to initiation of these agents in cycle 2.\n* Adequate hepatic function:\n\n  * AST and\u002For ALT up to 3 times upper limit of normal (unless elevation is secondary to disease involvement of the liver, in which case up to 5 times upper limit is permitted after discussion with the principal investigator).\n  * Total bilirubin up to 1.5 times upper limit of normal (unless elevation is secondary to Gilbert syndrome or of non - hepatic origin).\n* Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Primary mediastinal B cell lymphoma\n* Active central nervous system or meningeal involvement by lymphoma\n* History of severe allergic or anaphylactic reactions to anti-CD20 monoclonal antibody therapy\n* Active bacterial, viral, fungal, mycobacterial, parasitic or other infection requiring systemic therapy within 2 weeks prior to first dose of study drug. This includes participants with COVID-19 infection\n* History of active chronic infection by hepatitis B or C or Cytomegalovirus (CMV) requiring treatment or prophylaxis. Resolved infections (either by treatment or immune response) are not exclusion criterion.\n* Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). History of prior malignancy is not excluded.\n* HIV seropositivity.\n* Subjects with uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding women are excluded from this study because siltuximab therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with siltuximab, breastfeeding should be continued and not restarted for 3 months after the last dose of siltuximab. These potential risks may also apply to other agents used in this study.\n* Participants with history of clinically relevant and active CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n* Peripheral neuropathy assessed to be Grade \\>1 according to NCI CTCAE v5.0 at enrollment for participants anticipated to receive GemOx","ALL","18 Years","65 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to is to determine the safety, feasibility and efficacy of siltuximab prophylaxis of cytokine release syndrome and neurotoxicity occurring after epcoritamab subcutaneous administration for participants with large b-cell lymphoma (DLBCL) or follicular lymphoma (FL).\n\nParticipants will receive siltuximab, prior to the injection of epcoritamab. Epcoritamab is administered in 28 day cycles for one year. After this injection, the physician will continue to watch participants for side effects and follow the condition for a minimum of 60 days.",[27,28],"Non-Hodgkin Lymphoma","Cytokine Release Syndrome",[30,31,32],"Siltuximab","Epcoritamab","Prophylactic siltuximab","RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":37},"2025-01-14",{"date":41,"type":21},"2028-09-01",{"name":43,"class":44},"Taylor Brooks","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100641459","phase-2-infliximab-for-cytokine-release-syndrome-prophylaxis-during-teclistamab-or-talquetamab-therapy-in-patients-with-relapsed-or-refractory-myeloma-100641459","NCT07657312","Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma","Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab\u002FTalquetamab Therapy in Patients With Relapsed\u002FRefractory Myeloma","Inclusion Criteria:\n\n* Patients 18 years of age or older with evidence of relapsed or refractory disease as defined by IMWG criteria and measurable disease as defined by any of the following:\n\n  * Serum M-protein ≥ 0.5 g\u002Fdl\n  * Urine monoclonal protein ≥ 200 mg\u002F24h\n  * Involved free light chain (FLC) level ≥ 10mg\u002Fdl (≥ 100mg\u002Fl) and an abnormal serum free light chain ratio (\\\u003C 0.26, or \\> 1.65)\n* Patients must have had at least 4 prior lines of therapy including an immunomodulatory agent (IMID), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.\n\n  * Prior B-cell maturating antigen (BCMA) chimeric antigen receptor (CAR)-T is permitted but at least 6 months must have lapsed from CAR-T exposure\n  * Prior tumor necrosis factor alpha (TNFα) inhibitor use for a concomitant condition (ex. Rheumatoid arthritis) is permitted but at least 6 months must have lapsed from exposure\n* Patients must have hemoglobin ≥ 7g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1000\u002FµL\n* Platelets ≥ 50,000\u002FµL\n* Total bilirubin ≤ 1.5 X the upper limit of normal (ULN)\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \\\u003C 2.5 X the ULN\n* Calculated creatinine clearance of ≥ 30ml\u002Fmin using Modification of Diet in Renal Disease (MDRD) formula\n* Patients must have adequate cardiac function as evidenced by:\n\n  * Left ventricular ejection fraction ≥ 30%; baseline echocardiography (ECHO) is not required if ECHO was done within the preceding 6 months and patients do not have new signs\u002Fsymptoms suggestive of heart failure\n  * No uncontrolled arrhythmias\n  * No New York Heart Association class III-IV heart failure\n  * 12-lead electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of ≤ 470 msec\n* Negative test result for latent tuberculosis at screening\n* Patients must provide informed consent\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2\n* Fertility requirements\n\n  * Women of child bearing potential (WOCBP) must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device \\[IUD\\], hormonal \\[birth control pills, injections, hormonal patches, vaginal rings or implants\\] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks prior to dosing and continue to 6 months after study treatment ending or teclistamab\u002Ftalquetamab ending, whichever is longer. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy\n  * Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy\n  * A negative pregnancy test will be required for all WOCBP at screening and within 24 hours before starting treatment drugs, and with each cycle\n  * Breast feeding is not permitted\n  * Male patients must agree to use an adequate method of contraception (latex or synthetic condom) for the duration of the study and up to 6 months after study treatment ending\n  * Criteria also applies to azoospermic males\n  * Males should refrain from sperm donation during this time and continue for 6 months after study treatment ending\n\nExclusion Criteria:\n\n* Patients with Waldenstrom macroglobulinemia, primary amyloid light chain (AL) amyloidosis, primary plasma cell leukemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome\n* Patients receiving concurrent corticosteroids at the time protocol therapy is initiated other than for physiologic maintenance treatment\n* Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs\n* Live vaccines should not be given concurrently with infliximab. Vaccination with live virus vaccines is not recommended for at least 4 weeks prior to the start of treatment, during treatment and least 4 weeks after treatment\n* Clinically active rheumatoid arthritis (RA), psoriatic arthritis (PsA), and\u002For ankylosing spondylitis (AS), or concurrent use of abatacept, anakinra, rituximab, or other biologic products approved to treat these diseases within the preceding 6 months\n* Patients with history of anaphylaxis or hypersensitivity to etanercept, infliximab, adalimumab, certolizumab pegol, or golimumab\n* Unacceptable respiratory risk factors defined by any one of the following criteria:\n\n  * Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than 50% of predicted normal\n  * Moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification\n* Unacceptable cardiac risk factors defined by any of the following criteria:\n\n  * Left ventricular ejection fraction \\\u003C 30%\n  * Complete left bundle branch, bifascicular block or clinically significant abnormal electrocardiogram (EKG) finding at screening\n  * A prolongation of QT interval on Screening ECG as defined by repeated demonstration of a QTc interval \\> 470 msec using Fridericia's QT correction formula; a family history of Long QT Syndrome\n  * Myocardial infarction within 6 months\n  * Unstable angina\n* Unacceptable infectious risk factors defined by any of the following criteria:\n\n  * Active tuberculosis:\n\n    * History of active or latent tuberculosis (TB) before screening\n    * Any signs or symptoms suggestive of active TB upon medical history and\u002For physical examination\n    * Any known recent close contact with a person with active TB.\n  * Active invasive fungal infections\n  * Other active infections, including clinically important localized infections, and patients with a history of opportunistic infections\n* Unacceptable demyelinating neurologic risk factors including history or active multiple sclerosis, Guillain-Barre syndrome, optic neuritis, or peripheral demyelinating polyneuropathy\n* Patients who have received targeted or investigational agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is shorter) and who have not recovered from side effects of those therapies\n* Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from the side-effects of surgery\n* Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required\n* Patients with active hepatitis B (defined as hepatitis B surface antigen positive \\[HBsAg+\\]); hepatitis B virus (HBV) screening is required prior to beginning therapy\n\n  * Patients with prior hepatitis B vaccine are permitted (defined as hepatitis B surface antigen negative \\[HbsAg-\\], anti hepatitis B virus surface antibody positive \\[Anti-HBs+\\], anti hepatitis C virus surface antibody negative \\[Anti-HBc-\\])\n  * Non-active hepatitis B (HbsAg-, Anti-HBs+, Anti-HBc+) may be enrolled if on suppressive antiviral therapy and have no detectable viral load (additional monitoring for hepatitis B reactivation is advised)\n* Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention, other than non-melanoma skin cancer and carcinoma in situ of the cervix or breast, should not be enrolled\n* Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to them by the study staff\n* Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results",{"count":54,"type":21},35,[56],"PHASE2","This phase II trial tests how well giving infliximab works for the prevention of cytokine release syndrome (CRS) during treatment with teclistamab or talquetamab in patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CRS and neurologic toxicity (damage to the nervous system which includes the brain, spinal cord, and nerves) are potential risks of treatment with talquetamab and teclistamab. CRS involves a release of a large amount of proteins into the bloodstream causing inflammation. This may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and\u002For affect the lung\u002Fliver\u002Fkidney function. It may also cause certain brain-related symptoms, such as dizziness, weakness, confusion, difficulty speaking, and\u002For decreased brain function (possible paralysis and\u002For coma). Infliximab is a drug that prevents the tumor necrosis factor-alpha (TNF-α) from working. TNF-α is a cytokine, or chemical messenger, that helps your immune system produce inflammation. Giving infliximab may work well for the prevention of cytokine release syndrome during treatment with teclistamab or talquetamab in patients with relapsed or refractory multiple myeloma.",[28,59,60],"Recurrent Multiple Myeloma","Refractory Multiple Myeloma","NOT_YET_RECRUITING","2026-06-15",{"date":64,"type":37},"2026-06-18",{"date":66,"type":21},"2026-08-01",{"date":68,"type":21},"2027-12-31",{"name":70,"class":44},"Naresh Bumma",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":5},"100508815","phase-1-study-of-cto1681-for-the-prevention-and-treatment-of-crs-in-dlbcl-patients-receiving-car-t-cell-therapy-100508815","NCT05905328","Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy","Phase 1B\u002F2A Study of CTO1681 for the Prevention and Treatment of Cytokine Release Syndrome in Patients With Diffuse Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Undergone leukapheresis and is scheduled to receive protocol-specified commercially available CD19-directed CAR T-cell therapy (axicabtagene ciloleucel or lisocabtagene maraleucel) for DLBCL without corticosteroid prophylaxis for CRS and\u002For ICANS. Patients eligible for study must have relapsed or refractory DLBCL after at least one prior line of systemic therapy.\n3. Met all inclusion criteria for CAR T-cell therapy per institutional guidelines.\n4. Adequate organ function defined as:\n\n   1. Estimated Creatinine Clearance per Cockroft Gault formula ≥ 60 mL\u002Fmin.\n   2. Serum alanine aminotransferase\u002Faspartate aminotransferase ≤ 2.5 × ULN.\n   3. Total bilirubin ≤ 1.5 × ULN.\n   4. Left ventricular ejection fraction ≥ 40% on echocardiogram or multigated acquisition and no clinically significant pericardial effusion.\n   5. Platelets ≥ 50,000\u002Fmm3.\n   6. Absolute neutrophil count \\> 1000\u002FμL.\n   7. Absolute lymphocyte count \\> 100\u002FμL.\n5. Documented measurable lymphoma disease adequate to judge by Lugano Criteria.\n6. Eastern Cooperative Oncology Group performance status 0 to 1.\n7. Female participants of childbearing potential and all male participants must agree to use Investigator-approved methods of birth control while on study drug and for 30 days thereafter.\n8. Patients who are willing to provide written informed consent before the predose procedures, or patients who have a legal representative capable of providing informed consent on their behalf.\n\nExclusion Criteria:\n\n1. Any cytotoxic chemotherapy within 14 days prior to leukapheresis.\n2. Clinically significant malabsorption syndromes and swallowing difficulties which are inadequately controlled with medication (eg, odynophagia, dysphagia, gastroesophageal reflux disease) as per Investigator assessment.\n3. Grade 2 or greater electrolyte imbalance, per CTCAE v5.0:\n\n   1. Potassium \\\u003C 3.0 or \\> 5.5 mmol\u002FL\n   2. Sodium \\\u003C 130 or \\> 150 mmol\u002FL\n   3. Calcium \\\u003C 8.0 or \\> 11.5 mg\u002FdL\n   4. Magnesium \\\u003C 0.5 or \\> 1.23 mmol\u002FL\n4. Clinically significant ECG abnormality at Screening or Baseline (Day -1), including but not limited to, a confirmed QTcF value \\> 470 msec. Patients to be excluded included those with QTcF readings that are borderline or difficult to interpret because of a condition such as bundle branch block, or in those where the end of the T wave is difficult to measure. This also includes any Grade 2 or greater conduction block disorder, atrial, or ventricular arrythmia.\n5. History of clinically significant arrhythmia and\u002For requiring anticoagulation\u002Fantiplatelet treatment at therapeutic dose.\n6. Any clinically significant (ie, active) cardiovascular disease, including cerebral vascular accident\u002Fstroke (\\\u003C 6 months before enrollment), myocardial infarction (\\\u003C 6 months before enrollment) or unstable angina, and congestive heart failure ≥ New York Heart Association Classification Class III.\n7. Uncontrolled thromboembolic events or recent severe hemorrhage within the last 6 months.\n8. Known history of any bleeding disorder.\n9. Requirement for ongoing therapeutic doses of anticoagulant therapy, antiplatelet or fibrinolytic agents (low molecular weight heparin prophylaxis is allowed).\n10. Baseline systolic blood pressure \\\u003C100 mmHg.\n11. History of autoimmune disease\u002F graft versus host disease requiring immunosuppressive therapy within the last 2 years. However, physiologic steroids (prednisone equivalent) may be given at a dose of 5 mg or less.\n12. Patients who, in the opinion of the Investigator, would be unlikely to comply with study procedures or are otherwise unsuitable for enrollment.",{"count":79,"type":21},54,[24,56],"This is an interventional study to evaluate the use of CTO1681 in preventing or reducing CAR T-cell-induced toxicities like cytokine release syndrome (CRS). This study will enroll adult patients with DLBCL who are scheduled to receive CD19-directed CAR T-cell therapy.\n\nThe first phase of the study will be open label with dose escalation. Participants will start taking CTO1681 just prior to receiving their CAR T-cell therapy and continue to take the study drug three times daily for a total of 15 days.",[28],[84,85,86,87,88],"Cytokine release syndrome","Cytokine storm","Hypercytokinemia","Immunotoxicity","CAR T-cell therapy","2026-04-14",{"date":91,"type":37},"2026-04-17",{"date":93,"type":37},"2023-12-28",{"date":95,"type":21},"2027-06",{"name":97,"class":98},"CytoAgents, Inc.","INDUSTRY",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":45},"100622934","multimodal-telerehabilitation-in-patients-undergoing-car-t-cell-immunotherapy-100622934","NCT07390071","Multimodal Telerehabilitation in Patients Undergoing CAR-T Cell Immunotherapy","Inclusion Criteria:\n\n* age \\>21\n* confirmed diagnosis of lymphoma or myeloma\n* commercial FDA-approved CAR-T delivery planned for ≥4 weeks following enrollment\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Access to a working telephone line in their home or a cell phone.\n\nExclusion Criteria:\n\n* have unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures;\n* are engaged in a regular exercise rehabilitation program;\n* have relocation plans within next 6 months;\n* participate in another clinical trial.","21 Years",{"count":107,"type":21},40,[109],"NA","The proposed multimodal telerehabilitation model allows a rehabilitation therapy team to set up individualized rehabilitation plans using a web-based care management portal and monitor patient progress online. Patients at home follow a safe and effective personalized exercise and nutrition plan guided by interactive touch-screen technology combined with behavioral counseling, social support, and interactive education and empowerment. The design of the telerehabilitation system is based on the cloud-based Internet-of-Things architecture allowing real-time monitoring of cardiovascular parameters and exercise performance. The patient's level of exertion during exercise is automatically identified by a validated AI-driven algorithm supporting exercise safety and efficacy. The ultimate goal of this pilot feasibility project is to establish the extent of the impact of the proposed patient-centered cancer telerehabilitation model on disease-specific quality of life, and functional and symptom outcomes and to obtain sufficient evidence for a definitive randomized clinical trial evaluating this approach in a multi-center study.",[112,113,28,114],"Lymphoma","Myeloma","Immune Effector Cell Associated Neurotoxicity Syndrome","2026-01-28",{"date":117,"type":37},"2026-02-05",{"date":119,"type":37},"2025-09-01",{"date":121,"type":21},"2029-01",{"name":123,"class":44},"University of Utah",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":45},"100605972","phase-1-adjunctive-methylene-blue-for-immunotherapy-related-crs-and-icans-phase-i-study-100605972","NCT07169487","Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study","Exploration of Efficacy and Safety of Adjunctive Methylene Blue in the Treatment of Immunotherapy-related CRS and ICANS: A Prospective, Single-arm, Phase I Clinical Study","Inclusion Criteria:\n\n1. Diagnosed with hematologic malignancies based on cytomorphology and immunophenotyping; age ≥18 years.\n2. Received immunotherapy (e.g., CAR-T cells, bispecific antibodies) and developed CRS or ICANS of ASTCT Grade ≥1.\n3. Estimated life expectancy ≥3 months.\n4. Male and female participants of childbearing potential agree to use effective contraception.\n5. Left ventricular ejection fraction (LVEF) \\>45% by echocardiography.\n6. Ability to understand and sign informed consent and willingness to comply with study requirements.\n\nExclusion Criteria:\n\n1. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.\n2. Known allergy to methylene blue.\n3. Pregnant or breastfeeding women.\n4. Known HIV seropositivity. HIV testing may be required according to local laws or regulations.\n5. History of clinically significant ventricular arrhythmia, unexplained syncope (not vasovagal), sinoatrial block, or higher-degree atrioventricular (AV) block with chronic bradycardia (unless a permanent pacemaker is implanted).\n6. Psychiatric disorders that may interfere with completion of treatment or informed consent.\n7. Any other condition deemed unsuitable for participation by the investigator.",{"count":132,"type":21},18,[24],"This Phase I, prospective, single-arm clinical study aims to evaluate the efficacy and safety of adjunctive methylene blue (MB) in patients experiencing cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following CAR-T cell therapy or bispecific antibody treatment. Preclinical studies demonstrated that MB alleviates CRS\u002FICANS-related symptoms, preserves the antitumor function of T cells, and modulates neuroinflammation without compromising immune efficacy. The study will employ a 3+3 dose-escalation design with three MB dosing cohorts, with treatment administered intravenously for 3-5 consecutive days. Vital signs, laboratory markers, and neurological status will be closely monitored, and concomitant standard supportive therapies will be permitted.",[28,136],"ICANS",[138,28,139,140,141],"Methylene Blue","Immune Effector Cell-Associated Neurotoxicity Syndrome","CAR-T Cell Therapy","Immunotherapy-Related Toxicity","2025-09-05",{"date":144,"type":37},"2025-09-11",{"date":146,"type":37},"2025-06-28",{"date":148,"type":21},"2030-06-28",{"name":150,"class":44},"Institute of Hematology & Blood Diseases Hospital, China",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":45},"100570128","phase-1-pre-emptive-anakinra-for-cytokine-event-reduction-100570128","NCT06703216","Pre-emptive Anakinra for Cytokine Event Reduction","Pilot Study of Pre-emptive Anakinra for the Prevention of Severe Cytokine Release Syndrome in Children and Young Adults With B-Acute Lymphoblastic Leukemia Receiving Chimeric Antigen Receptor (CAR) T Cells","PACER","• Patient consent and parental assent will be obtained.\n\nNOTE: Signed consent form must be obtained prior to any study procedures. Labs, marrows or other procedures obtained during routine clinical care maybe used for eligibility if obtained within the protocol required windows.\n\n* Patients or their parents\u002Flegally authorized representatives (LARs) must have the ability to understand and the willingness to sign a written informed consent document.\n* The effects of Anakinra on the developing human fetus are largely unknown. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 90 days following completion of Anakinra therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 90 days after completion of administration.\n\nNote: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy\n* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)\n* Patients who are between the age of 1 to 26 years\n* Relapsed or refractory B-acute lymphoblastic leukemia\n\n  * 2nd or greater marrow relapse OR\n  * Central nervous system (CNS) relapse OR\n  * Any relapse after allogeneic hematopoietic stem cell transplant (HSCT) OR\n  * Refractory disease defined by not achieving an minimal residual disease (MRD)-negative complete remission (CR) after ≥ 2 chemotherapy cycles (1 cycle for relapsed patients) OR\n  * Ineligible for allogeneic HSCT because of:\n\n    * Comorbid disease\n    * Other contraindications to allogeneic HSCT conditioning\n    * No suitable donor\n    * Prior HSCT\n    * Declines HSCT as the therapeutic option after documented discussion, with expected outcomes, about the role of HSCT with a HSCT physician\n  * Documentation of CD19+ tumor expression in the bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry at relapse, or a recent sample in the case of refractory disease. If the patient has received CD19-directed Pre-emptive anakinra for severe CRS prevention therapy, the flow cytometry should be obtained after this therapy to show CD19 expression.\n* Adequate organ function defined as:\n\n  * Alanine aminotransferase (ALT) \\\u003C 500 U\u002FL\n  * Bilirubin ≤2.0 mg\u002FdL\n  * Minimum pulmonary reserve defined as ≤Grade 1 dyspnea, pulse oximetry \\>92% on room air; diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% (corrected for anemia) if pulmonary function tests (PFTs) are clinically appropriate as determined by the treating investigator.\n  * Left ventricular shortening fraction ≥ 28% or ejection fraction ≥40% confirmed by echocardiography (ECHO), or adequate ventricular function documented by imaging or a cardiologist.\n  * Serum creatinine below the values in the below table, based on age\u002Fsex assigned at birth: Maximum Serum Creatinine (mg\u002FdL) Age (years) Male Female 1 to \\\u003C2 0.6 0.6 2 to \\\u003C6 0.8 0.8 6 to \\\u003C10 1.0 1.0 10 to \\\u003C13 1.2 1.2 13 to \\\u003C16 1.5 1.4 ≥16 1.7 1.4\n* Bone marrow disease burden of ≥5% or peripheral blasts within 2 weeks of the start of lymphodepleting chemotherapy\n* Receiving commercially available tisagenlecleucel","1 Year","25 Years",{"count":162,"type":21},24,[24,56],"Objectives: The primary objective of this study will be to evaluate the impact of pre-emptive use of anakinra on the rate of severe cytokine release syndrome (CRS) following CD19-directed chimeric antigen receptor (CAR) T-cell therapy for B-acute lymphoblastic leukemia (B-ALL) in children and young adults.\n\nPatient Population: Children and young adults \\\u003C25 years of age undergoing CAR T-cell therapy for B-ALL with bone marrow disease burden of ≥5% involvement or detectable peripheral blasts within 2 weeks of the initiation of lymphodepleting chemotherapy.\n\nStudy Design: This is a pilot single arm study. The investigators will inquire into the efficacy and safety of using anakinra pre-emptively to reduce the rate of severe CRS in patients with \\>\u002F=5% bone marrow blasts or lymphoblasts in the peripheral blood.\n\nTreatment Plan:\n\nThis is a single arm unblinded study in which patients will receive anakinra, 2.5 mg\u002Fkg (max 100mg), IV every 12 hours starting at the onset of persistent fever (fever \\>38.5⁰ C x 2 occurrences separated by at least 4 hours in a 24 hour period). If there is persistence or progression of CRS, anakinra frequency will be increased to 2.5mg\u002Fkg IV (max 100mg), every 6 hours. Anakinra will be continued until 48 hours after resolution of CRS and ICANS, and at least 7 days post-CAR T infusion. If dose and frequency of anakinra is increased, the increased dose of anakinra will be continued until 48 hours after resolution of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) and at least 7 days post-CAR T infusion. For CRS worsening beyond dose escalation of anakinra, CRS will be managed as per standard of care management. Participants will be followed for 12 months following enrollment in the study and disease evaluations will be performed as per routine clinical care following CAR T-cell therapy.",[166,140,28,114,167],"B-Acute Lymphoblastic Leukemia","Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome",[169,28,170,171,172,173,174,114],"Anakinra","CAR-T Therapy","Pediatric","B-acute lymphoblastic leukemia","Prophylaxis","Inflammatory Toxicity","2025-06-12",{"date":177,"type":37},"2025-06-15",{"date":179,"type":21},"2025-08",{"date":181,"type":21},"2030-02-28",{"name":183,"class":44},"Ann & Robert H Lurie Children's Hospital of Chicago"]