[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"large-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:large-cell-lymphoma":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"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":4},"100627015","phase-1-car-t-cell-for-eradication-of-active-residual-disease-in-lbcl-clear-1-study-100627015",false,"NCT07443137","CAR-T ceLL for Eradication of Active Residual Disease in LBCL (CLEAR-1 Study)","Rapcabtagene Autoleucel for Eradication of Measurable Residual Disease in Large B-Cell Lymphoma (LBCL)","Inclusion Criteria:\n\nEligibility for Pre-Screening:\n\n1. Diagnosis: Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2022\\[1\\]:\n\n   • Diffuse large B cell lymphoma (DLBCL); OR\n\n   • Primary mediastinal (thymic) large B cell lymphoma; OR\n\n   • Transformation of indolent lymphomas (eg follicular lymphoma or marginal zone lymphoma)to DLBCL; OR\n   * High grade B-cell Lymphoma (NOS, or with MYC\u002FBCL2 rearrangements);\n   * Double hit lymphoma (DHL) \u002F Triple hit lymphoma (THL); OR\n   * Follicular lymphoma grade 3b\n2. Must have 10 unstained slides or tissue block from lymph node excision or core needle biopsy, or a lymph node biopsy (NOT FNA, bone or bone marrow biopsy), in 5 µm thickness FFPE with H\\&E slide available for ctDNA calibration.\n3. Must have intention to complete frontline chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline.\n4. In the investigator's assessment, is likely to be eligible to proceed to the treatment portion of this study with intention to undergo YTB323 if MRD positive.\n5. Must be able to understand and the willingness to sign the written IRB approved pre-screening informed consent document.\n\nEligibility Criteria for Screening\n\n1\\. Diagnosis: Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2022\\[1\\]:\n\n* Diffuse large B cell lymphoma (DLBCL); OR\n* Primary mediastinal (thymic) large B cell lymphoma; OR\n* Transformation of indolent lymphomas to DLBCL; OR\n* High grade B-cell Lymphoma;\n* Double hit lymphoma (DHL) \u002F Triple hit lymphoma (THL); OR\n* Follicular lymphoma grade 3b\n\n  2\\. Must have completed planned frontline chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline based therapy for LBCL indication with a CR or PR inaccessible for biopsy at end of treatment (EOT 1L).\n\n  3\\. Circulating tumor DNA is detectable by PhasED-seq within 12 weeks after completion of standard chemoimmunotherapy.\n\n  6\\. Normal Organ and Marrow Function\n\n  \\- ANC ≥ 1,000\u002FuL\n  * Platelet count ≥ 75,000\u002FuL\n  * Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n    * Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 45 mL\u002Fmin\n    * Serum ALT or AST ≤ 5 x ULN (except in subjects with liver involvement by lymphoma)\n    * Total bilirubin ≤ 1.5 mg\u002Fdl, except in subjects with Gilbert's syndrome.\n    * Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an Echocardiogram.\n  * No clinically significant pleural effusion or ascites\n  * Baseline oxygen saturation \\> 92% on room air 7. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) 8. Contraception: Subjects of child bearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study and for twelve (12) months after receiving the preparative lymphodepletion regimen.\n\n    9\\. Must be able to understand and the willingness to sign the written IRB approved informed consent document. Subjects unable to give informed consent will not be eligible for this study.\n\n    4\\. Age 18 years or older 5. Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2.\n\nExclusion Criteria:\n\n\\- 1. Prior treatment with CAR-T or adoptive cell therapy 2. Prior allogeneic transplant. 3. No bridging therapy permitted. 4. Active central nervous system disease from lymphoma. MRI of the brain with no evidence of CNS lymphoma if prior history of CNS involvement.\n\n5\\. Prior history of allergic reactions to any of the reagents used in the rapcabtagene autoleucel infusion.\n\n6\\. History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.\n\n7\\. History of T-cell histiocyte-rich large B-cell lymphoma. 8. Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment.\n\n9\\. Women who are pregnant or breastfeeding 10. History of invasive malignancy unless the patient has been disease-free for two years.\n\nExceptions include nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, and breast) and low grade prostate cancer (e.g. Gleason 3+3) Hormonal therapy in subjects in remission \\>1 year will be allowed. 11. History of stroke or transient ischemic attack within 12 months before enrollment, or seizure disorders requiring active anticonvulsive medication.\n\n12\\. In the investigator's judgment, the subject is unlikely to complete all study-specific visits or procedures, including follow-up visits, or comply with the study requirements for participation.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase 1b clinical trial to assess the efficacy of rapcabtagene autoleucel (YTB323) administered at the recommended dose in adults with Large B Cell Lymphoma (LBCL) who are at high risk of relapse at end of first line treatment (EOT), as defined by positive measurable residual disease detected by Foresight CLARITY (PhasED-seq). Participants will initially be pre-screened for MRD status after first line treatment (1L) with chemoimmunotherapy including a CD20 monoclonal antibody and anthracycline.",[26],"Large-cell Lymphoma","NOT_YET_RECRUITING","2026-06-03",{"date":30,"type":31},"2026-06-04","ACTUAL",{"date":33,"type":20},"2026-07",{"date":35,"type":20},"2028-08",{"name":37,"class":38},"Stanford University","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":57,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100511502","study-of-a-communication-training-intervention-for-large-b-cell-lymphoma-providers-100511502","NCT05940272","Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers","Evaluation of a Communication Intervention (Hematolo-GIST) for Large B-Cell Lymphoma Providers","Inclusion Criteria:\n\nProviders\n\n* Currently a an MSK provider caring for patients with DLBCL (including DLBCL-transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL) which are histologically similar and treated as large-cell lymphoma)\n\nPatients\n\n* Per medical record, is currently being treated by a provider who is participating in this study (for the purposes of this study, \"treating provider\" will be defined as any provider who provides care related to the patient's lymphoma diagnosis)\n* Per medical record, has a diagnosis of DLBCL including DLBCL-transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL) which are histologically similar and clinically treated as large-cell lymphoma\n* Per medical record, relapse\u002F refractory disease within 12 months of 4 cycles of first line therapy OR relapse after 2 cycles of later line therapy or or autologous stem cell transplant (ASCT)\n* Self-identify as Black and\u002For White\n* Per medical record, 18 years of age or older\n* Per self-report, fluent in English\\*\\*\n\n  * Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study:\n\n    1. How well do you speak English? (must respond \"very well\" or \"well\" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)\n    2. What is your preferred language for healthcare? (must respond English)\n\nExclusion Criteria:\n\nProviders\n\n* Per self-report, planning to leave the cancer center in the next 12 months\n\nPatients\n\n* Cognitively impaired as demonstrated by (Blessed Orientation- Memory- Concentration (BOMC) score of ≥ 11\n* Per research staff judgment and\u002For self-report, too ill or weak to complete study procedures\n* Per medical record or self-report, receiving hospice care at the time of enrollment",{"count":47,"type":20},48,[49],"NA","The purpose of this study is to develop and test a new communication training intervention called Hematolo-GIST to help oncologists communicate with patients about their lymphoma diagnosis and advance care planning.",[52,53,26,54,55,56],"Lymphoma, B-Cell","Lymphoma","Large B-cell Lymphoma","DLBCL - Diffuse Large B Cell Lymphoma","Mediastinal B-Cell Diffuse Large Cell Lymphoma",[58,59,60,61,62,63,64,56,65,66,67],"oncologist","hemotologic oncologist","lymphoma","large cell lymphoma","large b-cell lymphoma","DLBCL","Diffuse Large B Cell Lymphoma","Hematolo-GIST","23-164","Memorial Sloan Kettering Cancer Center","RECRUITING","2025-10-08",{"date":71,"type":31},"2025-10-09",{"date":73,"type":31},"2023-07-03",{"date":75,"type":20},"2028-07-03",{"name":67,"class":38},"Large Cell Lymphoma"]