[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"classic-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:classic-hodgkin-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,71,102,127,147,167,192,218,241,263],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100641676","neurocognitive-assessment-in-long-term-survivors-of-lymphoma-100641676",false,"NCT07652476","Neurocognitive Assessment in Long-Term Survivors of Lymphoma","Neurocognitive Assessment in Long-Term Survivors of Lymphoma: An Observational Study by the Fondazione Italiana Linfomi (FIL)","FIL_LymDeCo","Inclusion Criteria:\n\n* Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL).\n* Patients in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +\u002F- radiotherapy.\n* Age ≥ 25 and ≤ 55 at enrollment.\n* Patients between third and fifth year of follow-up after the end of the first line treatment.\n* Absence of signs or symptoms of disease relapse.\n\nExclusion Criteria:\n\n* Patients with CNS disease localization.\n* Patients that received brain\u002Fneuroaxis radiotherapy.\n* Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.","ALL","25 Years","55 Years",{"count":21,"type":22},100,"ESTIMATED","OBSERVATIONAL","This is an observational, multicenter, prospective cohort study including patients treated for lymphoma in Italian real-life. Patients eligible for the enrollment in the study will be consecutively included in Italian FIL centers. Patients will be evaluated once during regular follow-up, in the absence of clinical or radiologic signs of disease relapse.\n\nThe assessment of neurocognitive functioning will be performed through a panel of tests, both self-administered and individually administered (about 1 hour). The administration of these neuropsychological tests should be done according to a standardized and predefined order. If available, according to local practice, a neuropsychologist may be involved in test administration and in the evaluation of the results.\n\nBased on its observational nature, no treatment change or modification or additional exams or visits will be required because of being enrolled in this study.",[26,27,28],"Classic Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma (DLBCL)","Primary Mediastinal B Cell Lymphoma","NOT_YET_RECRUITING","2026-06-17",{"date":32,"type":33},"2026-06-22","ACTUAL",{"date":35,"type":22},"2026-09",{"date":37,"type":22},"2028-03",{"name":39,"class":40},"Fondazione Italiana Linfomi - ETS","OTHER",7,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100594633","phase-2-ctdna-guided-therapy-for-relapsedrefractory-hodgkin-lymphoma-100594633","NCT07021989","ctDNA-Guided Therapy for Relapsed\u002FRefractory Hodgkin Lymphoma","Pembrolizumab and GVD With ctDNA-guided Consolidation in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma: A Multicenter Phase 2 Study of the University of California Hematologic Malignancies Consortium","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Histologically confirmed classic Hodgkin lymphoma (including nodular sclerosis, lymphocyte-rich, mixed cellularity, and lymphocyte-depleted Hodgkin lymphoma).\n3. Participants must have relapsed or refractory disease after no more than one line of systemic therapy. First line therapy must have included doxorubicin.\n4. At least one site of FDG-avid disease on PET\u002FCT that is ≥ 1.5 cm in diameter for nodal disease or ≥ 1.0 cm in diameter if extranodal disease.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky ≥ 50%).\n6. Demonstrates adequate organ function as defined below:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.0 X 10\\^9\u002F L (1000\u002Fmicroliter (mcL), growth factors permitted).\n   2. Platelets ≥ 75 X 10\\^9 \u002F L (75,000\u002FmcL, platelet transfusion independent).\n   3. Total bilirubin ≤ 1.5 x institutional upper limit of normal, unless elevated due to Gilbert's syndrome.\n   4. Aspartate aminotransferase (AST) \u002F (SGOT) ≤3 x institutional upper limit of normal.\n   5. Alanine aminotransferase (ALT) \u002F (SGPT) ≤3 x institutional upper limit of normal.\n   6. Creatinine clearance (CrCl, calculated) ≥ 40 mL\u002Fmin\u002F1.73 m\\^2, calculated using the Cockcroft-Gault equation.\n7. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n8. Individuals with a history of hepatitis C virus (HCV) infection must have been treated with sustained virologic response. For individuals with HCV infection who are currently on treatment, participants are eligible if there is an undetectable HCV viral load.\n9. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n10. Individuals 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.\n11. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before start of trial therapy. A female is considered to not be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participants meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries). The result of the urine or serum pregnancy test must be negative in order to administer initiate trial therapy. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is a potential risk for adverse effects in the unborn child secondary to treatment of the study participant with trial therapy.\n12. Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Participants who previously received a programmed cell death protein 1 (PD-1) inhibitor-based regimen (e.g., nivolumab or pembrolizumab + AVD) and progressed within 6 months of last done of immune checkpoint inhibitor.\n2. Receipt of systemic anti-cancer therapies or radiation within 2 weeks prior to the start of trial therapy or receipt of antibody therapy within 4 weeks prior to the start of trial therapy.\n3. Has participated in a study of an investigational product and received study treatment or used an investigational device within four weeks of the first dose of treatment.\n4. Prior autologous or allogeneic hematopoietic stem cell transplant.\n5. Systemic autoimmune disease requiring continuous immunosuppressive treatment (≥prednisone 10 mg per day or equivalent), with the exception of autoimmune thyroid disease.\n6. Left ventricular ejection fraction (LVEF) \\\u003C50% as assessed by transthoracic echocardiogram or multigated acquisition (MUGA) scan.\n7. Participants whose lifetime cumulative dose of doxorubicin would exceed 450 mg\u002Fm\\^2 after receiving 4 cycles of pembro + GVD are excluded (i.e., \\>330 mg\u002Fm\\^2 at trial entry).\n8. Has known hypersensitivity to pembrolizumab, gemcitabine, vinorelbine, and\u002For liposomal doxorubicin; or any of their excipients.\n9. Has any significant medical condition or comorbidity that could compromise participants safety in the opinion of the treating investigator (e.g., uncontrolled serious infection).\n10. Individuals who are pregnant or breast-feeding\u002Fchest-feeding. Pregnant and breastfeeding individuals are excluded because there is a potential risk for adverse effects in the unborn\u002Fnursing child secondary to treatment of the study participant with trial therapies. Females of reproductive potential must have a negative pregnancy test before initiation of trial therapy, as outlined in inclusion criterion #12. Breast-feeding should be discontinued before initiation of trial therapy.\n11. Individuals with ongoing Grade 2 events that are not clinically stable or ongoing ≥ Grade 3 events (CTCAE v5.0 grading).\n12. Notification from Foresight Diagnostics that the CLARITY LDT baseline specimen has failed sample quality control (QC) and\u002For the baseline ctDNA is not quantifiable. Note: Foresight will only notify sites if the specimen fails quality control (QC) or is not quantifiable. Sites will not receive notification if the specimen passes QC and is quantifiable. For QC failures, a sample re-draw may be considered upon discussion with and approval by the lead University of California, San Francisco (UCSF) Principal Investigator.\n13. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities, interfere with participant safety, or study endpoints.","18 Years",{"count":51,"type":22},38,"INTERVENTIONAL",[54],"PHASE2","This is a single arm, open-label, multicenter, phase II study of pembrolizumab (pembro), gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) in patients with relapsed or refractory classic Hodgkin lymphoma (cHL) with response-adapted consolidation. This study will investigate using circulating tumor DNA (ctDNA) at pre-determined time points using Foresight CLARITY LDT, an ultra-sensitive liquid biopsy platform that detects Minimal residual disease (MRD) in patients with B-cell lymphomas using the phased variant enrichment and sequencing technology (PhasEDq) to determine response to study interventions.",[57,58,26],"Hodgkin Lymphoma, Adult","Refractory Hodgkin Lymphoma",[60],"circulating tumor DNA","2026-06-02",{"date":63,"type":33},"2026-06-04",{"date":65,"type":22},"2026-07-01",{"date":67,"type":22},"2033-12-31",{"name":69,"class":40},"Michael Spinner, MD",6,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":52,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100635632","pilot-study-of-bone-mineral-density-changes-during-anti-pd-1-immunotherapy-100635632","NCT07555210","Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy","Pilot Study Assessment of Bone Mineral Density Changes During Treatment With Anti-PD-1 Immunotherapy Agents","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients planning to start or within the first four weeks of treatment with anti-PD-1 immune checkpoint inhibitor therapy either alone or in combination with chemotherapy for curative intent for a known cancer diagnosis (use of immunotherapy must be FDA-approved and not experimental).\n3. Life expectancy of at least 12 months per the discretion of the treating physician.\n\nExclusion Criteria:\n\n1. Patients ineligible for anti-PD-1 therapy.\n2. Patients with metastatic disease.\n3. Patients planning treatment with dual immune checkpoint inhibitor therapy.\n4. Bony fractures in the pelvis, bilateral hips\u002Ffemurs, thoracic spine, or lumbar spine.\n5. Known osteoporosis or osteopenia.\n6. Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months.\n7. Parathyroid gland disorders, rheumatoid arthritis (unless well-controlled off active biologic therapy without chronic steroid use), CKD stage IV\u002FV, or ESRD.\n8. Inability to comply with study procedures.\n9. Inability to lie flat for 20-25 minutes during an imaging session.\n10. Pregnant or breastfeeding patients.\n11. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.",{"count":79,"type":22},25,[81],"NA","Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells. However, these agents, now approved for over 15 types of cancers and for both early-stage and metastatic disease, are capable of causing inflammation in any organ system of the body that can lead to organ damage, dysfunction, and even death in rare cases. Some patients may suffer acute and treatable complications like joint pain, but some may have irreversible complications like hypothyroidism that requires daily, life-long medication. It is therefore important to fully understand the different types of damage ICIs can cause to better monitor patients receiving ICI therapy.\n\nA rising concern from recent reports in the literature is that ICIs may weaken bone and increase the risk of fractures. In this study, the investigators aim to characterize how ICIs impact the bone by examining several factors in patients undergoing curative-intent ICI treatment either alone or in combination with chemotherapy: bone mineral density, bone volume, and markers of bone turnover in the blood. The study will use two imaging techniques to assess bone mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays to measure how dense (or strong) bones are and is often used to diagnose or assess the risk of osteoporosis. High-resolution peripheral quantitative computed tomography (HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and offers high resolution that can be used to assess bone in smaller bones of the peripheral skeleton.\n\nThe investigators hypothesize that ICI treatment will weaken bones and increase the risk of fractures. As ICI therapy is relatively new, a rising number of patients may be at risk of fractures or have low bone density that is not being monitored because there are no guidelines in place notifying physicians of this potential risk to patients. This is study will provide important preliminary data that will be the basis for larger studies in the future aiming to better monitor and potentially treat bone weakening in patients treated with ICIs to reduce the pain, inconvenience, and complications from fragility fractures.",[84,85,86,87,88,89,90,26],"Breast Cancer (Triple Negative Breast Cancer (TNBC))","Renal Cell Carcinoma (Kidney Cancer)","Melanoma (Skin Cancer)","Non-Small Cell Lung Cancer","MSI-H\u002FdMMR Rectal Cancer","Squamous Cell Carcinoma Mouth","Invasive Mammary Carcinoma","RECRUITING","2026-05-04",{"date":94,"type":33},"2026-05-06",{"date":96,"type":33},"2025-08-25",{"date":98,"type":22},"2028-07-01",{"name":100,"class":40},"Jessica Mezzanotte Sharpe",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100493467","a-study-about-how-blood-cell-growth-patterns-relate-to-heart-health-after-treatment-for-hodgkin-lymphoma-100493467","NCT05705531","A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma","Assessment of Clonal Hematopoiesis and Its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors","Inclusion Criteria:\n\n* Patient must be \\>= 7 years of age at the time of enrollment (age to perform an MRI without sedation).\n* History of pathologically confirmed classical Hodgkin Lymphoma (cHL) initially diagnosed when the patient was \\>= 2 and \\\u003C 22 years of age.\n* As part of frontline therapy for cHL, the patient must have received a cumulative doxorubicin equivalent anthracycline dose of ≥ 200 mg\u002Fm\\^2 as estimated in doxorubicin isotoxic equivalents dose conversion calculation.\n\n  * Note: History of COG therapeutic trial participation is not required. Institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) can be used as reference documentation of receipt of anthracycline dose.\n* All systemic cancer treatment must have been completed ≥ 2 years prior to study enrollment.\n* Not known to have had a primary event (relapse\u002Fsecond malignancy\u002Fdeath).\n\n  * Note: Subjects treated at another institution are eligible if they are now being followed at the current COG institution, if the study procedures can be performed and the data accessible by a COG institution where the study is open.\n* Patient must have access to cardiac MRI at the enrolling institution and must be able to complete cardiac MRI without sedation.\n\nExclusion Criteria:\n\n* Medical contraindication to undergoing a non-contrast cardiac MRI.\n* Patients with nodular lymphocyte-predominant HL.\n* Received cancer therapy in addition to that for primary Hodgkin Disease (e.g., for disease progression or recurrence, or subsequent malignant neoplasm).\n* History of CTCAE grade 3 or higher cardiovascular disease or condition known to exist prior to the patient's initial diagnosis of cHL.\n\n  * Note: exceptions are made for congenital conditions considered fully resolved by surgery and chronic conditions such as hypertension or hypercholesterolemia that are managed with medical intervention.\n* History of an immunodeficiency that existed prior to cHL diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and conditions requiring systemic immunosuppressive agents.","7 Years",{"count":111,"type":22},190,"This study assesses how blood cell growth patterns (clonal hematopoiesis) relate to heart health or cardiovascular disease (CVD) after treatment in patients with Hodgkin lymphoma. In some patients, cancer treatment at a young age may lead to later complications, including problems with heart health. Checking for blood cell growth patterns called therapy-related clonal hematopoiesis (t-CH) can help predict who might be at risk for heart health problems after Hodgkin lymphoma treatment. If doctors know who may be at greater risk for developing later heart complications, then they can more closely monitor those patients to prevent or detect heart complications early.",[114,26,115],"Cardiovascular Disorder","Clonal Hematopoiesis","2026-05-01",{"date":118,"type":33},"2026-05-05",{"date":120,"type":33},"2023-08-18",{"date":122,"type":22},"2028-10-01",{"name":124,"class":125},"Children's Oncology Group","NETWORK",32,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":52,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":101},"100512244","phase-2-pianzumab-combined-with-avd-regimen-in-the-treatment-of-newly-diagnosed-advanced-classic-hodgkin-lymphoma-100512244","NCT05949931","Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma","A Randomized, Open, Multicenter Phase II Clinical Trial of Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma (PENAHL Study)","Inclusion Criteria:\n\n1. Age: ≥18 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months;\n2. classic Hodgkin lymphoma (cHL) confirmed by histopathology;\n3. The subject must be advanced patient, specifically defined as Ann Arbor stage III-IV or IIB with any of the following high-risk factors: ① maximum diameter of mediastinal mass\u002Fmaximum diameter of thoracic cavity\\>0.33; ② There are large masses with a diameter of\\>10cm;\n4. Have not received systemic anti classic Hodgkin lymphoma treatment;\n5. Measurable disease ;\n6. Adequate main organs function\n7. Female subjects of childbearing age should agree to use contraceptives (such as Intrauterine device, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine Pregnancy test was negative within 7 days before the study was included, and must be non-lactating subjects; Male participants should agree to use contraception during the study period and within 6 months after the end of the study period.\n\nExclusion Criteria:\n\n1. Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma;\n2. Classic Hodgkin lymphoma involves the central nervous system;\n3. Subjects who have or are suspected to have active autoimmune diseases within the past 2 years, or have previously suffered from autoimmune diseases and are currently at high risk of recurrence and require systemic treatment；\n4. Subjects who need to use glucocorticoid (\\>10mg\u002Fday prednisone Equivalent dose) or other immunosuppressive drugs for systemic treatment within 14 days before the first administration.\n5. Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration;\n6. Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n7. Known to have active pulmonary tuberculosis;\n8. Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases;\n9. Subjects with a known history of interstitial pneumonia, a history of non-infectious pneumonia, or highly suspected cases of interstitial pneumonia;\n10. Patients with evidence of bleeding constitution or medical history; Within 4 weeks before the first medication, any ≥ CTC AE level 3 bleeding events (such as digestive tract bleeding, perforation, etc.) occur;\n11. Concomitant diseases and medical history:\n\n    1. Has experienced or currently suffers from other malignant tumors within 3 years.\n    2. Multiple factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction);\n    3. Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;\n    4. Subjects with any severe and\u002For uncontrollable disease.",{"count":135,"type":22},108,[54],"This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.",[26],"2026-04-27",{"date":116,"type":33},{"date":142,"type":33},"2023-10-01",{"date":144,"type":22},"2027-12",{"name":146,"class":40},"Sun Yat-sen University",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":52,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":101},"100614101","phase-2-pembrolizumab-in-combination-with-chemotherapy-for-the-treatment-of-frail-hodgkin-lymphoma-patients-ineligible-for-standard-treatment-100614101","NCT07275216","Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment","Phase 2 Study of Pembrolizumab With Chemotherapy in Frail Patients With Newly Diagnosed Classical Hodgkin Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Meets at least one of the following criteria indicating unsuitability for conventional anthracycline-based frontline chemotherapy, as determined by the investigator:\n\n  * Age ≥ 75 years\n  * Eastern Cooperative Oncology Group (ECOG) 2-4\n  * Left ventricular ejection fraction (LVEF) \\\u003C 50%\n  * Creatinine clearance \\\u003C 60 mL\u002Fmin, using Cockcroft-Gault formula or equivalent\n  * Pulmonary function impairment: forced expiratory volume in 1 second (FEV1) \\\u003C 50% and\u002For diffusion capacity of the lung for carbon monoxide (DLCO) \\\u003C 50%\n* ECOG ≤ 2\n* Age ≥ 18 years\n* Histologically confirmed new diagnosis of classical Hodgkin lymphoma (excluding nodular lymphocyte predominant Hodgkin lymphoma) according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution\n* No prior systemic treatment for classical Hodgkin lymphoma with the following exceptions: a course of systemic corticosteroids for palliation of symptoms related to the classical Hodgkin lymphoma is allowed but must be stopped by cycle 1 day 1 (C1D1) as well as prior treatment with P-G as part of this clinical trial for patients will receive P-BV-D\n* Measurable disease (at least one non-bone fludeoxyglucose F-18 \\[FDG\\]-avid lesion ≥ 1.5 cm in long axis)\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets ≥ 50,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 2 × upper limit of normal (ULN) or direct bilirubin ≤ 2 × ULN for patients with Gilbert's disease\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN\n* AST and ALT ≤ 3 x ULN unless there is liver involvement by lymphoma in which case AST and ALT \\\u003C 5 x ULN\n* For patients for whom P-BV-D therapy is planned, creatinine clearance of ≥ 30 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN\n\n  * If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n\n  * If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants\n* Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HBV or HCV, nucleic acid quantitation must be performed. Viral load must be undetectable. Patients with occult or prior HBV infection (defined as negative hepatitis B virus surface antigen \\[HBsAg\\] and positive hepatitis B core antibody \\[HBcAb\\]) may be included if HBV DNA is undetectable, if they are willing to undergo DNA testing on day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* A male participant must agree to use a contraception during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP) OR\n  * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least (X days\u002Fweeks \\[corresponding to time needed to eliminate any study treatment(s)\\] \\[pembrolizumab and\u002For any active comparator\u002Fcombination\\] plus 30 days \\[a menstruation cycle\\] for study treatments with risk of genotoxicity) after the last dose of study treatment\n* TO PROCEED WITH SALVAGE TREATMENT: ECOG ≤ 2\n* TO PROCEED WITH SALVAGE TREATMENT: Resolution of treatment-related adverse events (AEs) to baseline or grade 1, whichever is higher\n* TO PROCEED WITH SALVAGE TREATMENT: Measurable disease (at least one non-bony FDG-avid lesion ≥ 1.5 cm in long axis)\n* TO PROCEED WITH SALVAGE TREATMENT: Peripheral neuropathy ≤ grade 2\n* TO PROCEED WITH SALVAGE TREATMENT: ANC ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factors are permitted\n* TO PROCEED WITH SALVAGE TREATMENT: Platelets ≥ 50,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are permitted\n* TO PROCEED WITH SALVAGE TREATMENT: Hemoglobin ≥ 8 g\u002FdL (no transfusion allowed within 3 days prior to screening)\n* TO PROCEED WITH SALVAGE TREATMENT: Total bilirubin ≤ 2 x ULN or direct bilirubin ≤ 2 x ULN for patients with Gilbert's disease\n* TO PROCEED WITH SALVAGE TREATMENT: AST ≤ 3 x ULN, or less then 5 x ULN for patients with liver involvement by lymphoma\n* TO PROCEED WITH SALVAGE TREATMENT: ALT ≤ 3 x ULN, or less then 5 x ULN for patients with liver involvement by lymphoma\n* TO PROCEED WITH SALVAGE TREATMENT: Creatinine clearance of ≥ 30 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula\n\nExclusion Criteria:\n\n* Concomitant investigational therapy\n* Live vaccine within 30 days prior to day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacille Calmette Guerin \\[BCG\\], oral polio vaccine, and oral typhoid)\n* Grade ≥ 2 peripheral neuropathy\n* Requirement for hemodialysis or peritoneal dialysis. Estimated glomerular filtration rate (EGFR) \\> 30 for pembrolizumab + BV + dacarbazine\n* Known active central nervous system (CNS) involvement by lymphoma including parenchymal and\u002For lymphomatous meningitis\n* History of prior ≥ grade 3 hypersensitivity to either brentuximab vedotin or pembrolizumab\n* Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)\n* History of another primary malignancy that has been in remission for fewer than 3 years, with the following exceptions:\n\n  * Non-melanoma skin cancer treated with curative intent\n  * In situ cervical cancer\n  * If the malignancy is expected to not require any systemic treatment for at least 2 years (this exception should be discussed with the study PI)\n* Condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Exceptions are:\n\n  * Inhaled or topical steroids and\n  * Adrenal replacement doses \\> 10 mg daily prednisone equivalents in the absence of active autoimmune disease\n  * Up to 7 days of 20 mg daily prednisone equivalent after C1D1 for management of lymphoma-related symptoms\n* History of progressive multifocal leukoencephalopathy (PML)\n* Active pneumonitis or interstitial lung disease\n* Prior solid organ or allogeneic stem cell transplantation\n* History of known or suspected hemophagocytic lymphohistiocytosis (HLH)\n* Active, known or suspected autoimmune disease. The following are exceptions:\n\n  * Vitiligo\n  * Psoriasis not requiring systemic treatment\n  * Hemolytic anemia associated with the lymphoma\n  * Type I diabetes mellitus, if adequately controlled with therapy\n  * Thyroid disease, if adequately controlled with therapy\n  * Conditions not expected to recur in the absence of an external trigger (such exceptions should be discussed with the study PI)\n* Active history of:\n\n  * Hepatitis B (HBV) or C (HCV) infection. Patients with past HBV infection (defined as negative HBsAg and positive hepatitis B core antibody \\[HBcAb\\]) are eligible if HBV DNA is undetectable. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV RNA\n* HIV positive\n* History of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association class III-IV within 6 months prior to day 1 of protocol therapy\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":155,"type":22},23,[54],"This phase II trial tests how well pembrolizumab in addition to chemotherapy (gemcitabine, brentuximab vedotin, and dacarbazine) works in treating frail patients with newly diagnosed Hodgkin lymphoma who aren't candidates for standard anthracycline-based treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Dacarbazine is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells and slow down or stop cancer growth. Pembrolizumab in combination chemotherapy may be a safe and effective alternative treatment option for frail patients with Hodgkin lymphoma who can't receive standard anthracycline-based treatment.",[26],"2026-04-20",{"date":161,"type":33},"2026-04-23",{"date":65,"type":22},{"date":164,"type":22},"2029-10-20",{"name":166,"class":40},"City of Hope Medical Center",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":52,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":191},"100573345","phase-2-personalized-reduction-of-chemotherapy-intensity-through-ctdna-evaluation-for-the-treatment-of-patients-with-advanced-hodgkin-lymphoma-100573345","NCT06745076","Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma","A Multicenter Study PRECISE-HL: Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation in Advanced Hodgkin Lymphoma","Inclusion Criteria:\n\n* Classical Hodgkin lymphoma without prior systemic therapy, stage 3 or 4. Corticosteroids for symptom relief are allowed\n* Measurable disease per Lugano criteria\n* Patients must be appropriate candidates for 6 cycles of combination chemotherapy including an anthracycline\n* No evidence of active central nervous system lymphoma\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) ≥ 500\u002Fmm\\^3. Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma\n* Platelets ≥ 50,000\u002Fmm\\^3 (without transfusion or growth factor support). Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma\n* Hemoglobin ≥ 8 g\u002FdL. Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma\n* Serum creatinine \\\u003C 1.5 x upper limits of normal (ULN) or creatinine clearance greater than 30\u002Fml per minute by Cockcroft Gault formula\n* Total bilirubin ≤ 1.5 times upper limit of normal OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN). Patients with Gilbert Syndrome and direct bilirubin \\\u003C 1.5 x ULN or confirmatory UGT1A1 testing are allowed to enroll\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (≤ 5 × ULN for participants with liver involvement)\n* Patients must be age 18 or older\n* All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines\n* Patients must be anticipated to complete all planned study therapy\n* Male patients must agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\n* Female patients of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year\n\nExclusion Criteria:\n\n* Patients known positive for HIV or infectious hepatitis type B or C with a detectable viral load may not participate. Hepatitis B\u002FC, and HIV testing are not required at screening unless mandated by local health authority.\n\n  * Patients living with HIV, on anti-viral treatment and undetectable viral load are allowed\n  * Patients with positive hepatitis (hep) B core antibody are allowed on study with an undetectable viral load and appropriate prophylaxis\n  * Patients with positive hepatitis C antibody are allowed with undetectable viral load\n* Pregnant or nursing women. Men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method\n* Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 2 years or greater, unless approved by the principal investigator\n* Patients who have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, uncontrolled arrhythmia, severe pulmonary disease or requirement of supplemental oxygen)\n* Active ischemic heart disease (eg. myocardial infarction within 6 months) or congestive heart failure (eg. left ventricular ejection fraction \\\u003C 50%)\n* Concurrent use of other anti-cancer agents or experimental treatments\n* Known current or prior autoimmune disease with the exception of vitiligo. Patients with a history of autoimmune thyroid disease on a stable dose of thyroid hormone are also allowed\n* Active or prior history of pneumonitis\u002Finterstitial lung disease that required corticosteroids\n* Current use of supplemental oxygen\n* Is known to have received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Other non-live or live-attenuated vaccines (eg. COVID, Influenza) are allowed",{"count":175,"type":22},125,[54],"This phase II trial tests how well personalized reduction of chemotherapy (nivolumab, doxorubicin, vinblastine and dacarbazine) based on circulating tumor deoxyribonucleic acid (ctDNA) evaluation works for treating patients with Hodgkin lymphoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Chemotherapy drugs, such as nivolumab, doxorubicin, vinblastine and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many types of tumors tend to lose cells or release different types of cellular products including their DNA, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids and, based on the result, assign patients to a reduced number of chemotherapy treatments or the standard number of chemotherapy treatments. Using ctDNA to assign a personalized reduction of chemotherapy may be effective in treating patients with advanced Hodgkin lymphoma.",[179,26,180,181],"Advanced Hodgkin Lymphoma","Lugano Classification Stage III Hodgkin Lymphoma AJCC v8","Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8","2026-03-04",{"date":184,"type":33},"2026-03-05",{"date":186,"type":33},"2025-03-06",{"date":188,"type":22},"2033-01-03",{"name":190,"class":40},"University of Washington",5,{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":52,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":101},"100545103","phase-2-mt2022-60-ph-2-study-of-pembro-beam-with-asct-for-relapsed-hodgkin-lymphoma-100545103","NCT06377540","MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma","MT2022-60: A Phase II Study of Pembrolizumab+ BEAM Conditioning Regimen Before Autologous Stem Cell Transplant (ASCT) Followed by Pembrolizumab Maintenance in Patients of Relapsed or Refractory Classic Hodgkin Lymphoma","Inclusion Criteria:\n\n* Eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen\n* KPS greater than 70 or ECOG ≤ 1\n* Adequate organ function and blood counts within 14 days of study registration\n* Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.\n* Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n* HIV-infected participants must have well-controlled HIV on ART\n\nExclusion Criteria:\n\n* Patients with prior history of any grade 2 or higher autoimmune reaction to PD-1 inhibitors, necessitating permanent discontinuation of the PD-1 inhibitor or necessitating systemic immunosuppressants.\n* Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Has received any chemotherapy within 3 weeks prior to the first dose of study intervention\n* Has known active CNS disease.\n* History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents. Exceptions: Participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren's syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (≤ 10 mg\u002Fd) may enroll.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Pregnant or breastfeeding as agents used in this study are Pregnancy Category D (positive evidence of risk). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days of study registration",{"count":200,"type":22},28,[54],"This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.",[204,26],"Autologous Stem Cell Transplant",[206,207,208],"BEAM","cHL","ASCT","2025-06-27",{"date":211,"type":33},"2025-07-01",{"date":213,"type":33},"2024-12-04",{"date":215,"type":22},"2027-09-01",{"name":217,"class":40},"Masonic Cancer Center, University of Minnesota",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":52,"phases":227,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":101},"100565485","phase-1-a-study-of-ak129-with-or-without-ak117-in-pdl1-refractory-classic-hodgkin-lymphoma-100565485","NCT06642792","A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma","A Phase I\u002FII Study of AK129 (Bispecific Antibody Targeting LAG-3 and PD-1) Monotherapy or in Combination With AK117 (Anti-CD47 Monoclonal Antibody) in Relapse or Refractory Classic Hodgkin Lymphoma With PD-1\u002FL1 Inhibitor Treatment Failure","Inclusion Criteria:\n\n* Age ≥ 18 years old at the time of enrolment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Expected Survival of ≥ 12 weeks.\n* Diagnosed as R\u002FR cHL according to Lugano 2014 criteria.\n* Has progressed on treatment with PD-1\u002FL1 inhibitior therapy.\n* Has adequate organ function.\n* All female and male subjects of reproductive potential must agree to use an effective method of contraception from the start of screening until 120 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) or gray zone lymphoma.\n* Central nervous system (CNS) lymphoma involvement.\n* Known history of human T-cell leukemia virus type 1 (HTLV-1) infection.\n* Autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T cell immunotherapy (CAR-T) within 90 days prior to the first dose of study treatment.\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n* Previous use of any agents targeting the CD47-SIRPα pathway, LAG-3 pathway, or similar targets.\n* Has other malignancies within 3 years prior to the first dose or residual lesions from other malignancies diagnosed more than 3 years ago.\n* Has an active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.\n* History of active or previously confirmed inflammatory bowel disease.\n* History of interstitial lung disease requiring corticosteroid therapy, or current interstitial lung disease.\n* Has known active Hepatitis B or Hepatitis C.\n* Unresolved toxicity from previous anti-tumor treatment.\n* Uncontrolled comorbidities.",{"count":226,"type":22},280,[228,54],"PHASE1","This is a phase I\u002FII study. All subjects are patients diagnosed with relapse or refractory (R\u002FR) classic Hodgkin lymphoma (cHL) and has progressed on treatment with PD-1\u002FL1 inhibitor therapy. The purpose of this study is to evaluate the safety and efficacy of AK129 (bispecific antibody targeting LAG-3 and PD-1) monotherapy or in combination with AK117 (anti-CD47 monoclonal antibody) in R\u002FR cHL with PD-1\u002FL1 inhibitor treatment failure.",[26],"2025-02-09",{"date":233,"type":33},"2025-02-11",{"date":235,"type":33},"2025-01-17",{"date":237,"type":22},"2028-02",{"name":239,"class":240},"Akeso","INDUSTRY",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":52,"phases":250,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100551850","phase-3-a-study-of-imm01-plus-tiselizumab-versus-physicians-choice-chemotherapy-in-pdl1-refractory-classical-hodgkin-lymphoma-100551850","NCT06465446","A Study of IMM01 Plus Tiselizumab Versus Physician's Choice Chemotherapy in PD(L)1-refractory Classical Hodgkin Lymphoma","A Phase III Randomized, Open-label, Multicenter Clinical Study of IMM01 (Timdarpacept) in Combiniation With Tiselizumab Versus Physician's Choice Chemotherapy in PD-(L)1-refractory Classical Hodgkin Lymphoma","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL).\n* PD (L)-1 refractory cHL and exhausted all available treatment options with known clinical benefit.\n* Has adequate bone marrow reserves and organ functions.\n\nExclusion Criteria:\n\n* History of central nervous system (CNS) metastases or active CNS involvement.\n* Received prior systemic anticancer therapy within 4 weeks before randomization.\n* Received prior ani-CD47 or SIRPa treatment.\n* History of human immunodeficiency virus (HIV).\n* Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.\n* History of severve allergic reactions to any components of trail durg, humanized antibodies or fusion proteins.",{"count":249,"type":22},202,[251],"PHASE3","The purpose of this study is to compare efficacy of IMM01 plus Tiselizumab with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of IMM01 plus Tiselizumab. The primary study hypotheses are that IMM01 plus Tiselizuma is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).",[26],"2024-06-19",{"date":256,"type":33},"2024-06-24",{"date":258,"type":22},"2024-06",{"date":260,"type":22},"2029-07",{"name":262,"class":40},"ImmuneOnco Biopharmaceuticals (Shanghai) Inc.",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":52,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":101},"100512642","phase-1-a-study-of-ilb2109-and-toripalimab-in-patients-with-advanced-solid-malignancies-100512642","NCT05955105","A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies","A Phase Ib\u002FIIa, Multicenter, Open-label Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Adult patients between the ages of 18 and 80 years.\n2. Patients with histologically or cytologically confirmed solid tumours that are advanced, metastatic and or progressive, for whom there is no effective standard therapy available.\n3. Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤2.\n4. Expected life expectancy ≥3 months.\n5. Evaluable disease, either measurable on imaging, or with informative tumour marker(s), as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Eisenhauer, et al. 2009).\n6. Laboratory values at Screening:\n\n   Absolute neutrophil count ≥1.5 x 109\u002FL; Platelets ≥75 x 109\u002FL; Hemoglobin ≥ 90g\u002FL; Total bilirubin \\\u003C1.5 times the upper limit of normal; Aspartate aminotransferase (AST) ≤3 times the upper limit of normal, ≤ 5 times the upper limit of normal if subject has hepatic malignancies; Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal, ≤ 5 times the upper limit of normal if subject has hepatic malignancies; Estimated glomerular filtration rate (GFR) of \\>50 mL\u002Fmin (based on the Cockcroft-Gault formula; International Normalized Ratio (INR) and activated Partial Thromboplastin Time (aPTT) ≤1.5 times the upper limit of normal; Left Ventricular Ejection Fraction (LVEF) ≥ 50%; Corrected QT Interval by Fridericia Method: male\\\u003C450ms, female\\\u003C470ms; and\n7. Negative human chorionic gonadotropin (hCG) test in women of childbearing potential.\n8. Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g. barrier methods with spermicides, oral or parenteral contraceptives and\u002For intrauterine devices) during the entire duration of the study and for 90 days after final administration of ILB-2109, or the patient must be surgically sterile .\n9. Ability to give written, informed consent prior to any study-specific Screening procedures.\n\nExclusion Criteria:\n\n1. In the past 3 weeks: received systemic anti-tumor therapy, including chemotherapy, radiation, biologics, androgen, targeted therapy and immunotherapy with the following exceptions: i. received treatment containing nitrosoureas or mitomycin C in the past 6 weeks; ii. received oral fluorouracil or small molecule targeted therapy or Chinese Traditional Medicine (CTM) with anti-neoplasm indication in the past 2 weeks ;\n2. In the past 4 weeks: received any other investigational treatment;\n3. Gastrointestinal disease (e.g. Crohn's disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption;\n4. Uncontrollable third-spacing of fluids;\n5. Known CNS metastasis with clinical symptoms or the need of steroid treatment or CNS lesion ≥ 1.5cm or with the evidence of lesion enlargement in the past 4 weeks;\n6. Severe cardiovascular diseases including symptomatic heart failure (NYHA Class II and above), unstable angina, arrythmia, myocardial infarction within the past 6 months, embolism or pulmonary embolism within the past 3 months;\n7. Having any risk factors of QT prolongation, including present or family history of long QT syndrome or using any medication with known QT prolongation effect;\n8. Poor controlled chronic diseases, including poorly controlled diabetes mellitus (defined as HbA1c ≥ 8.5%), poorly controlled hypertension, has a history of hypertensive emergency or hypertensive encephalopathy, endocrine diseases that require systemic therapy;\n9. Current diagnosis of interstitial pneumonia or a history of chronic emphysema, COPD, or TB infection;\n10. Autoimmune diseases that required systemic therapy within the past 2 years, with the exception of vitiligo, asthma, atopic diseases and autoimmune thyroid diseases that are stable on thyroid replacement therapy;\n11. Active infection with the need if IV antibiotic treatment;\n12. Known HIV infection;\n13. Active HBV infection (defined as positive HBsAg and HBV-DNA\\>500 IU\u002Fml), active HCV infection (positive HCV antibody but HCV-RNA \\\u003C lower limit of detection is allowed to participate);\n14. Known syphilis infection;\n15. Received systemic steroid at a dose greater or equivalent to 10mg of prednisone per day or other immune modulating treatments in the past 14 days;\n16. Plan to receive live vaccine during the study period (4 weeks prior to the 1st dose till 6 months after the last dose);\n17. Major surgery within the past 4 weeks;\n18. Previous allogeneic bone marrow transplant or solid organ transplant;\n19. Known history of psychiatric disease\u002Falcohol or drug abuse that would affect subject's compliance to trial protocol;\n20. Any unresolved toxicities from prior therapies higher than CTCAE grade 1 with the following exceptions: i. alopecia; ii. peripheral neuropathy; iii. thyroid function abnormalities that can be treated with replacement therapy;\n21. Known history of CTCAE grade 3 and above irAE in previous immunotherapies;\n22. Known allergy to ILB-2109 or Toripalimab;\n23. Subjects who are currently pregnant or breastfeeding;\n24. Other conditions that in the opinion of the investigator will make the subject unfit to participate in this trial;","80 Years",{"count":272,"type":22},200,[228,54],"This is a multicenter, open-label, phase Ib\u002FIIa study. The first part of the study will evaluate the safety, tolerability and preliminary efficacy of ILB2109 and Toripalimab in patients with locally advanced or metastatic solid malignancies. The second part of the study will evaluate the efficacy of ILB2109 and Toripalimab in patients with selected advanced solid malignancies.",[276,277,278,279,280,281,282,283,284,26],"Head and Neck Cancer","Cervical Cancer","Endometrial Cancer","Triple Negative Breast Cancer","Ovarian Cancer","Soft Tissue Sarcoma","Melanoma","Nasopharyngeal Carcinoma","Non Small Cell Lung Cancer","2024-05-19",{"date":287,"type":33},"2024-05-21",{"date":289,"type":33},"2023-07-25",{"date":291,"type":22},"2026-07-24",{"name":293,"class":240},"Innolake Biopharm"]