[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoma-non-hodgkins-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoma-non-hodgkins-adult":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,85],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100555305","phase-2-epcoritamab-in-patients-with-follicular-lymphoma-not-accomplishing-a-cr-with-upfront-chemoimmunotherapy-100555305",false,"NCT06510361","Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy","A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy","Inclusion Criteria:\n\n* Biopsy-confirmed (fresh or archival tissue) follicular lymphoma grade 1-3A that is CD20+ (by immunophenotype or immunohistochemistry) at time of diagnosis. All degrees of CD20 positivity will be accepted. Composite high-grade lymphoma will be excluded.\n* Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm and short axis \\>1.0 cm and Deauville ≥ 4 seen on baseline PET\u002FCT\n* Stage III\u002FIV at initial diagnosis\n* 1 prior line (at least 3 cycles) of systemic \"upfront\" or first-line therapy consisting of anti-CD20 antibody (e.g. obinutuzumab or rituximab) combined with chemotherapy (e.g. bendamustine, CHOP, CVP, or lenalidomide). Rituximab monotherapy, rituximab plus radiation, or radiation alone is not sufficient.\n* Subjects need to have achieved a partial response or stable disease as best response following upfront treatment. Subjects with progressive disease will be excluded.\n* Subjects must have completed all prior anti-lymphoma therapy at least 4 weeks (28 days) prior to start of epcoritamab.\n* Age ≥18 years.\n* 3.1.7 Age ≥18 years.\n* ECOG performance status ≤ 2\n* Life expectancy of greater than 2 years\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1000 cells\u002Fmcl (G-CSF allowed if marrow involved with disease)\n  * Platelets ≥75,000 cells\u002Fmcl (transfusion allowed if marrow involved)\n  * Hemoglobin ≥ 8 g\u002FdL (transfusion allowed if marrow involved)\n  * Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). In patients with suspected\u002Fknown Gilbert's disease total bilirubin up to 3x ULN will be allowed\n  * AST(SGOT)\u002FALT(SGPT) ≤3× institutional ULN unless suspected\u002Fknown involvement by follicular lymphoma\n  * Creatinine ≤ institutional ULN OR creatinine clearance \\> 45 ml\u002Fmin (by Cockcroft-Gault estimate or 24-hr creatinine clearance measurement)\n* Patients with hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible but will be required to receive appropriate antiviral prophylaxis as described in Section 5.4. Patients with Hepatitis C antibody must have undetectable viral load.\n* Participants with a history of prior malignancy will be eligible if all treatment of that malignancy was completed at least 2 years prior to enrollment to this study, the treatment was considered \"curable-intent\", and there is currently no evidence of disease.\n* Resolution of toxicities from prior therapy to baseline or grade ≤1 (with the exception of grade 2 peripheral neuropathy or any grade alopecia)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Females of childbearing potential must agree to practice a highly effective method of birth control (as defined by the EU Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials:\n\n  * Established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception;\n  * Placement of an intrauterine device (IUD) or intrauterine system (IUS);\n  * Male partner sterilization (the vasectomized partner should be the sole partner for that patient)\n  * True abstinence (when this is in line with the preferred and usual lifestyle of the patient)\n* Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of epcoritamab. Men must also not donate sperm during the trial and for 12 months after receiving the last dose of epcoritamab.\n* A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (i.e. use of condom) during the trial and for 12 months after receiving the last dose of epcoritamab.\n\nExclusion Criteria:\n\n* Use of investigational agents incorporated into prior induction therapy\n* Uncontrolled intercurrent active infection requiring hospitalization or intravenous antimicrobial agents within 4 weeks of start of treatment\n* Uncontrolled underlying cardiac conditions including but not limited to congestive heart failure grade III or IV (by NYHA) or EF \\\u003C45%, unstable angina pectoris, acute myocardial infarction \\< 6 months, cardiac arrhythmia\n* History of uncontrolled neurologic condition including but not limited to seizure disorder, stroke, psychosis, dementia, CNS vasculitis, encephalitis\n* EF \\\u003C45% or need for supplemental O2 at rest to maintain SaO2\\>89%\n* Immunosuppressive therapy for non-lymphoma-related indication within 28 days (or for lymphoma within 10 days) of initiation of treatment, including systemic corticosteroids 10 mg\u002Fday or greater of prednisone or equivalent\n* Patients with known or suspected CNS involvement or leptomeningeal disease are excluded given concern for potentially increased risk of neurologic toxicity with epcoritamab. Patients with history of CNS malignancy from separate malignancy must have completed CNS-directed therapy and must currently have no evidence of disease\n* Pregnant or breastfeeding women or participants unwilling to adhere to institutional guidelines for highly effective contraception for the duration of the therapy are excluded. This is because of the unknown but potential risk of teratogenic or abortifacient effects, as well as potential for adverse events in nursing infants secondary to treatment of the mother, as epcoritamab has not yet been studied in this patient population. A female can be determined to not be of childbearing potential if she meets any of the following criteria:\n\n  * Premenarchal\n  * Postmenopausal (\\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \\[FSH\\] level \\>40 IU\u002FL or mIU\u002FmL)\n  * Permanently sterilized (e.g., bilateral tubal occlusion \\[which includes tubal ligation procedures as consistent with local regulations\\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy)\n\nNote: If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 3.1.15.\n\n* Known current alcohol or drug abuse, psychiatric illness, or unstable social situation that is likely to limit compliance with study requirements\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab\n* Exposure to a live or a live attenuated vaccine within 4 weeks\n* Patients with HIV will be excluded","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment.\n\nThe name of the study drug in this research study is:\n\n-Epcoritamab (a type of antibody)",[26,27,28,29],"Lymphoma","Follicular Lymphoma","Lymphoma,Non-Hodgkin","Lymphoma, Non-Hodgkin's, Adult",[27,26,31,29],"Lymphoma, Non-Hodgkin","RECRUITING","2026-03-12",{"date":35,"type":36},"2026-03-13","ACTUAL",{"date":38,"type":36},"2024-11-20",{"date":40,"type":20},"2028-05-01",{"name":42,"class":43},"Beth Israel Deaconess Medical Center","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":70,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100542472","phase-1-t-cell-therapy-eb103-in-adults-with-relapsedrefractory-b-cell-non-hodgkins-lymphoma-nhl-100542472","NCT06343311","T-Cell Therapy (EB103) in Adults With Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (NHL)","An Open-Label, Dose Escalation, Multi-Center Phase I\u002FII Clinical Trial of EB103 T-Cell Therapy in Adults With Relapsed\u002FRefractory (R\u002FR) B-Cell Non-Hodgkin's Lymphoma (NHL)","STARLIGHT-1","Inclusion Criteria:\n\n* Age 18 years or older at the time of informed consent\n* Histologically confirmed R\u002FR B-cell non-Hodgkin's lymphoma (NHL)\n* Adequate organ function\n* Relapsed or refractory (R\u002FR) disease defined as ONE OR MORE of the following:\n\n  * R\u002FR after ≥ 2 lines of systemic therapy\n\n    * For the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R\u002FR after ≥ 1 lines of systemic therapy\n  * Disease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)\n  * For subjects who are considered transplant-ineligible: progressive disease as best response after ≥ 4 cycles of first-line therapy and stable disease as best response after ≥ 2 cycles of second-line (salvage) therapy; subject must have received an anti-CD20 monoclonal antibody and an anthracycline as one of their qualifying regimens\n* All subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:\n\n  * Anti-CD20 monoclonal antibody AND\n  * An anthracycline-containing chemotherapy regimen\n* Positron emission tomography (PET)-positive disease according to Cheson 2014\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Toxicities due to prior therapy must be stable and recovered to Grade 1 or less\n\nExclusion Criteria:\n\n* Prior CD19-targeted cellular therapy\n* History of Richter's transformation of chronic lymphocytic leukemia (CLL)\n* History of another primary malignancy that has not been in remission for ≥ 2 years.\n* History or presence of clinically relevant Central Nervous System (CNS) pathology\n* CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms\n* Subjects with active cardiac lymphoma involvement which is not responding to treatment\n* History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent\n* Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with HIV, hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.\n* History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years\n* History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents\n* Venous thrombosis or embolism not managed on a stable regimen of anticoagulation\n* Autologous HSCT within 3 months of informed consent\n* Subjects with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced graft-versus-host disease (GvHD) that requires ongoing treatment with systemic steroids or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening\n* Live vaccine within 3 months prior to planned start of conditioning regimen",{"count":53,"type":20},21,[55,23],"PHASE1","This is an open-label, dose escalation, multi-center, Phase I\u002FII clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed\u002Frefractory (R\u002FR) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase.",[58,59,60,61,62,63,29,26,64,65,31,66,67,68,69],"B-Cell Non-Hodgkin's Lymphoma (NHL)","Lymphoma, Non-Hodgkins","Lymphomas Non-Hodgkin's B-Cell","Non-Hodgkin Lymphoma","Non-Hodgkin's Lymphoma","Large B-Cell Lymphoma","Refractory Non-Hodgkin Lymphoma","Relapsed Non-Hodgkin Lymphoma","HIV Associated Lymphoma","CNS Lymphoma","High-grade B-cell Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma",[71,62,72,26,63,64,65,73,67,68,69],"B-Cell Non-Hodgkin's Lymphoma","NHL","HIV Lymphoma","2025-08-04",{"date":76,"type":36},"2025-08-07",{"date":78,"type":36},"2024-06-01",{"date":80,"type":20},"2027-12-31",{"name":82,"class":83},"Estrella Biopharma, Inc.","INDUSTRY",2,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100514542","early-phase-1-study-of-sp-3164-in-relapsed-or-refractory-non-hodgkins-lymphoma-100514542","NCT05979857","Study of SP-3164 in Relapsed or Refractory Non-Hodgkin's Lymphoma","A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SP-3164 in Patients With Relapsed\u002FRefractory Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\nDiagnosis (WHO 2016 criteria) of R\u002FR B-cell NHL in dose escalation (part 1) and limited to R\u002FR DLBCL in dose selection optimization (part 2) confirmed by biopsy and immunophenotyping\n\nDose escalation: at time of enrollment, R\u002FR B-cell NHL patients per WHO 2016 criteria including DLBCL (including low grade transformed lymphoma), mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma and must:\n\n* require treatment in the opinion of the Investigator\n* received at least 2 lines of systemic therapy for B-cell NHL\n\nDose selection optimization: at time of enrollment, R\u002FR DLBCL (including low grade transformed lymphoma) patients must have received 2 or 3 lines of systemic therapy for DLBCL\n\no Prior immunomodulatory imide drug (IMiD) therapy is allowed (e.g., lenalidomide)\n\nMeasurable disease per the 2017 International Working Group Consensus Response Evaluation Criteria for Lymphoma\n\nEastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n\nExisting archival tumor tissue (fresh frozen paraffin embedded \\[FFPE\\], 5 unstained slides) not older than 2 years from Cycle 1 Day 1 or willingness to provide fresh tumor biopsy during screening\n\nNormal organ and marrow function, defined by specific laboratory parameters\n\nAbility to take orally administered medication\n\nWashout period prior to Cycle 1 Day 1 of SP-3164: at least 21 days or 5 half-lives (whichever is shorter) from prior systemic anticancer treatment, including chemotherapy, biologic therapy, small molecule inhibitors, monoclonal antibodies, and any investigational agents; at least 14 days from palliative radiotherapy if ≤ 10 fractions or total dose ≤ 30 gray (Gy) or at least 28 days from radiotherapy if total dose \\> 30 Gy; at least 21 days from major surgery\n\nLife expectancy of at least 3 months\n\nExclusion Criteria:\n\nPatients with chronic lymphocytic leukemia, high grade B-cell lymphoma, or Richter's syndrome\n\nPatients who have not recovered to Grade 1 toxicity or baseline due to any previous anticancer therapy according to the NCI CTCAE v5.0, excluding Grade 2 alopecia. Lymphopenia ≤ Grade 2 is allowed\n\nPatients with primary central nervous system (CNS) lymphoma or active CNS or meningeal lymphomatous involvement\n\nPersistent diarrhea or malabsorption of ≥ Grade 2 despite medical management\n\nImpaired cardiac function or clinically significant cardiac disease, including symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) \\\u003C 50%, unstable angina pectoris or cardiac arrhythmias, baseline QTc (Fridericia) \\> 450 milliseconds, long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, myocardial infarct within 6 months of study enrollment, clinically significant pericardial disease\n\nSolid organ transplant recipient\n\nAllogeneic stem cell transplantation (SCT) recipient\n\nAutologous SCT recipient \\\u003C100 days from Cycle 1 Day 1 or otherwise not fully recovered from SCT-related toxicity\n\nCompletion of CAR-T therapy \\\u003C 90 days from Cycle 1 Day 1\n\nSystemic immunosuppressants and chronic systemic corticosteroids (at doses ≥ 10 mg\u002Fday of prednisone or equivalent) are prohibited\n\nMalignant disease, other than that being treated in this study. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded. Other exceptions include malignancies that were treated curatively and have not recurred within 3 years prior to Cycle 1 Day 1 and any malignancy considered indolent and that has never required therapy\n\nOther concurrent severe or uncontrolled concomitant medical conditions that might cause unacceptable safety risks or compromise compliance with the protocol\n\nPregnant and breastfeeding women\n\nKnown history of HIV-positivity; known hepatitis B or hepatitis C virus infection\n\nMen and women of child-bearing potential unwilling to use adequate contraception according to study protocol",{"count":93,"type":20},72,[95],"EARLY_PHASE1","The purpose of this research is to help researchers find out if SP-3164 is safe and if it may be of benefit in the treatment of patients with Non-Hodgkin's lymphoma that has progressed after prior treatment, or that never responded to previous treatment.",[29],"NOT_YET_RECRUITING","2023-11-20",{"date":101,"type":36},"2023-11-22",{"date":103,"type":20},"2024-03-15",{"date":105,"type":20},"2027-08-15",{"name":107,"class":83},"Salarius Pharmaceuticals, LLC"]