[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hodgkin-lymphoma-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hodgkin-lymphoma-adult":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,66,87,122,149],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100594633","phase-2-ctdna-guided-therapy-for-relapsedrefractory-hodgkin-lymphoma-100594633",false,"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.","ALL","18 Years",{"count":19,"type":20},38,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Hodgkin Lymphoma, Adult","Refractory Hodgkin Lymphoma","Classic Hodgkin Lymphoma",[30],"circulating tumor DNA","NOT_YET_RECRUITING","2026-06-02",{"date":34,"type":35},"2026-06-04","ACTUAL",{"date":37,"type":20},"2026-07-01",{"date":39,"type":20},"2033-12-31",{"name":41,"class":42},"Michael Spinner, MD","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100548514","cardiopulmonary-function-and-cerebral-blood-flow-in-hodgkin-lymphoma-survivors-100548514","NCT06421987","Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors","Inclusion Criteria:\n\nHL Survivors\n\n* Completed bleomycin and\u002For thoracic radiation therapy for HL at SJCRH.\n* \\\u003C21-years old at diagnosis; currently ≥18-years of age and ≥2-years post therapy.\n* SJLIFE or ACT\u002FSJLIFE participants\n* English language proficiency.\n\nCommunity Controls\n\n* SJLIFE control.\n* ≥18-years of age at the time of enrollment with age sampling to broadly match the HL survivors.\n\nExclusion Criteria:\n\nHL Survivors\n\n* History of cranial or total-body irradiation therapy.\n* History of intrathecal or high dose intravenous antimetabolite therapy.\n* History of head injury or diagnosis of a genetic disorder associated with cognitive impairment.",true,{"count":51,"type":20},100,"OBSERVATIONAL","SURVIVORS\n\nStudy participants are being asked to take part in this research study called HODNIRS because the participant is a survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital. The study is being done to help investigators understand the link between long term effects of chest radiation and bleomycin for HL and brain function in survivors.\n\nPrimary Objective To evaluate dynamic changes in CBF and oxygenation during exercise with Near Infrared Spectroscopy (NIRS) in HL survivors and non-cancer controls matched for age, sex, race, and ethnicity. .\n\nSecondary Objectives To examine the degree of CO2 clearance (DLCO\u002FETCO2) during rest and exercise in Hodgkin Lymphoma (HL) survivors compared to non-cancer controls matched for age, sex, race, and ethnicity.\n\nCONTROLS\n\nVolunteers are being asked to take part in this research study because they are non-first degree relative or friend of someone who received treatment for a childhood cancer or similar illness at St. Jude Children's Research Hospital or are an employee\u002Faffiliate of St. Jude Children's Research Hospital and have agreed to be a St. Jude Life Cohort Study (SJLIFE) community control.",[26],"RECRUITING","2026-04-21",{"date":58,"type":35},"2026-04-23",{"date":60,"type":35},"2024-05-06",{"date":62,"type":20},"2027-12",{"name":64,"class":42},"St. Jude Children's Research Hospital",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":65},"100591724","phase-2-nivo40-avd-for-advanced-classic-hodgkin-lymphoma-100591724","NCT06984146","Nivo40-AVD for Advanced Classic Hodgkin Lymphoma","Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma\n2. No past history of autoimmune disease\n3. Age \\> 18 years\n4. Ejection fraction \\> 50%\n5. ECOG 0-4\n\nExclusion Criteria:\n\n1. Organ failure (e.g. creatinine \\> 2x ULN; ALT or AST \\> 5x ULN; bilirubin \\> 2x ULN; hemodynamic instability; respiratory failure \\> Grade 1)\n2. Uncontrolled infection\n3. Pregnancy\n4. Inability to sign informed consent",{"count":74,"type":20},54,[23],"The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma",[26],"2025-11-20",{"date":80,"type":35},"2025-11-26",{"date":82,"type":35},"2025-04-15",{"date":84,"type":20},"2029-01",{"name":86,"class":42},"National Medical Research Radiological Centre of the Ministry of Health of Russia",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":100,"conditions":101,"keywords":108,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":121},"100500641","phase-1-safety-and-preliminary-efficacy-of-mt-601-in-patients-with-relapsedrefractory-lymphoma-100500641","NCT05798897","Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed\u002FRefractory Lymphoma","A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-601) Administered to Patients With Relapsed or Refractory Non-Hodgkin and Hodgkin Lymphoma (APOLLO)","APOLLO","Inclusion Criteria:\n\n* All applicable inclusion and exclusion criteria must be met at Screening and at Baseline (re-assessment of eligibility within 14 days prior to group assignment).\n\nParticipants are eligible to be included in the study only if all of the following criteria apply and the participant, in the judgement of the Investigator, is an appropriate candidate for experimental therapy:\n\nGeneral:\n\n1. Participant must be ≥ 18 years of age and capable of giving signed informed consent (ICF), which includes compliance with the requirements and restrictions listed in the ICF and in the protocol, at the time of signing the ICF.\n\n   Disease Specific:\n2. Cytologically or histologically confirmed diagnosis of NHL, HL or CLL based on the 2022 World Health Organization (WHO) criteria for hematolymphoid neoplasms\n3. Enrollment of the following subtypes will be eligible:\n\n   1. LBCL including diffuse large B cell lymphoma, primary mediastinal B cell lymphoma (PMBCL), high grade B cell lymphoma (HGBL), T cell rich B cell lymphoma and transformed indolent lymphoma (transformed iNHL)\n   2. FL\n   3. MCL\n   4. MZL\n   5. HL\n\n      The following additional subtypes may be enrolled in disease specific cohorts during Dose Expansion (upon approval by Sponsor)\n   6. CLL\u002FSLL\n   7. CNS lymphoma\n   8. CAR T cell refractory\n4. Must have measurable disease as per 2014 Lugano criteria or 2018 iwCLL criteria. Participants with splenic MZL must have measurable splenomegaly on imaging or evidence of bone marrow involvement.\n\n   Prior Treatments\n5. Participants who are R\u002FR, are intolerant to, or are considered ineligible for systemic standard of care anticancer treatments, including at least 2 prior therapies. Participants who refuse standard of care treatments may also be considered if documentation is provided that he\u002Fshe has been made aware of all therapeutic options.\n6. For participants with LBCL, FL, and MCL: Have received CD19-directed CAR T cell therapy and relapsed ≥ 30 days or attained an incomplete response as the best response within 1 year after CAR T cell administration. Participants who refuse or are ineligible for CAR T cell therapy are eligible for this study. Note: during Dose Expansion, a specific cohort may be enrolled to evaluate participants who were refractory to CD19-directed CAR T cell therapy.\n\n   Health Status\n7. Karnofsky score of ≥70 or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale\n8. Life expectancy ≥12 weeks\n9. Adequate blood, liver, renal and cardiac function:\n\n   1. Hematology: Hemoglobin ≥ 7.0 g\u002FdL (can be transfused), absolute lymphocyte count (ALC) ≥ 300\u002FμL, (prior to apheresis only), absolute neutrophil count (ANC) ≥ 750\u002FμL and platelet count ≥ 50,000\u002FμL (prior to the conditioning regimen only)\n   2. Liver: Bilirubin ≤ 1.5X upper limit of normal (ULN) (exception of bilirubin elevation due to Gilbert's syndrome 3X); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3X ULN\n   3. Renal: Serum creatinine ≤ 1.5X ULN or measured or calculated creatinine clearance ≥ 50 mL\u002Fmin (prior to the conditioning regimen)\n   4. Cardiac: left ventricular ejection fraction ≥ 45% (prior to the leukapheresis) Sex\n10. Female: Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (i.e., with a failure rate of \\\u003C 1% per year), preferably with low user dependency during the intervention period and for at least 6 months after the last infusion of MT-601 and agrees not to donate eggs (i.e., ova and oocytes) for the purpose of reproduction during this period\n11. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 months after the last infusion of MT-601:\n\nRefrain from donating sperm\n\nPLUS either:\n\nBe abstinent from intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Must agree to use a male condom AND should also be advised of the benefit for a nonpregnant female partner to use a highly effective method of contraception as a condom may break or leak\n\nExclusion Criteria:\n\n* Patients are excluded from the study if any of the following criteria apply:\n\nDisease-related\n\n1. Evidence of bulky disease at the time of the conditioning regimen (≥ 10 cm in diameter for LBCL or HL and \\> 6 cm for other subtypes)\n2. Untreated or ongoing treatment for CNS lymphoma or completed treatment within 2 weeks of apheresis (Note: May be allowed in Dose Expansion if disease specific cohort for CNS lymphoma is opened)\n3. Refractory to CAR T therapy defined as a best response of stable disease or disease progression (Note: May be allowed in Dose Expansion if disease specific cohort for CAR T cell therapy refractory is opened)\n4. Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression Medical Conditions\n5. Primary immunodeficiency\n6. Severe or uncontrolled autoimmune disorder\n7. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis\n8. Unresolved immune effector cell-associated neurotoxicity syndrome (ICANS) from prior CAR T cell administration. Consideration for Grade 1 may be made after discussion with the Medical Monitor\n9. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast, and\u002For prostate) unless disease free for at least 3 years\n10. Cardiac conditions:\n\n    1. Medically uncontrolled hypertension (≥ 160 mmHg systolic blood pressure or ≥ 100 mmHg diastolic blood pressure)\n    2. Congestive heart failure Class ≥ II as defined by the New York Heart Association\n    3. Acute coronary syndrome (including unstable angina, coronary artery stenting, or angioplasty, bypass grafting within prior 6 months)\n    4. History or evidence of current, uncontrolled, clinically significant, unstable arrhythmias\n11. Oxygen saturation at room air \\\u003C 92%\n12. Participant has known human immunodeficiency virus (HIV) infection, or active hepatitis B virus (HBV)\u002Fhepatitis C virus (HCV) infection\n13. Acute bacterial, viral, fungal infection requiring systemic therapy (uncomplicated urinary tract infection and bacterial pharyngitis are permitted if responding to therapy)\n14. History of severe allergic reactions to any of the study intervention components including conditioning regimen, dimethyl sulfoxide (DMSO) or to tocilizumab\n15. Clinically significant reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline\n\n    * Participants with Grade 2 neuropathies due to prior treatment will be allowed on study.\n    * Participants with clinical nonsignificant toxicities, such as alopecia, will be allowed on study.\n\n    Prior\u002FConcomitant Therapy\n\n    Prior to Apheresis:\n16. Receipt of allogeneic hematopoietic cell transplant (HCT) within 12 months; on immunosuppression or with evidence of donor\u002Fmixed chimera\n17. Receipt of autologous HCT within 3 months\n18. Treatment with CD19-directed CAR T cell therapy within 3 months\n19. Treatment with bispecific antibody within 1 month\n20. Treatment with antibody drug conjugates (ADC's) or PD-1\u002FPD-L1 within 21 days\n21. Treatment with monoclonal antibodies impacting T cell function within 14 days\n22. Treatment with systemic immunosuppression including systemic corticosteroids (unless ≤5 mg\u002Fday oral prednisone or steroid equivalent) within 14 days\n23. Treatment with chemotherapy within 7 days\n\n    Prior to the conditioning regimen:\n24. Treatment with a live, attenuated vaccine within 4 weeks\n25. Treatment with antibody drug conjugates (ADC's) or PD-1\u002FPD-L1 within 21 days\n26. Treatment with chemotherapy or biologics\u002Fmonoclonal antibodies within 14 days\n27. Treatment with radiation therapy within 7 days\n28. Treatment with a tyrosine kinase inhibitor (TKI) within 7 days or 5 half-lives (whichever is longer) before conditioning regimen\n29. Hematopoietic growth factors \\\u003C2 days\n\n    At either time:\n30. Treatment with experimental CAR T cell product unless approved by Medical Monitor\n31. Treatment with other cancer therapy including investigational agents that do not fit in the above categories within 14 days\n32. Major surgery within 14 days\n\n    Other\n33. Pregnant or lactating\n34. Any other issue which, in the opinion of the treating physician, would make the participant ineligible for the study","100 Years",{"count":97,"type":20},79,[99],"PHASE1","This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory Lymphoma. The starting dose administered is 200 x 10\\^6 cells (flat dosing).",[102,103,104,105,106,26,107],"Non-Hodgkin Lymphoma, Adult","Non-Hodgkin Lymphoma, Refractory","Non-Hodgkin Lymphoma, Relapsed","Non Hodgkin Lymphoma","Hodgkin Lymphoma","Hodgkin's Lymphoma, Relapsed, Adult",[109,110],"NHL","Lymphoma","2025-08-14",{"date":113,"type":35},"2025-08-20",{"date":115,"type":35},"2023-01-02",{"date":117,"type":20},"2028-02-28",{"name":119,"class":120},"Marker Therapeutics, Inc.","INDUSTRY",7,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100411535","phase-3-first-line-chemotherapy-for-classical-hodgkin-lymphoma-in-russia-hl-russia-1-100411535","NCT04638790","First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)","First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia","HL-Russia-1","Inclusion Criteria:\n\n* Histologically confirmed classical HL\n* Previously untreated disease\n* Age 18-5 years\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2\n* Adequate organ and marrow function as defined below: absolute neutrophil count \\>1,0 x109\u002FL, platelets \\>75 x109\u002FL\n* Total bilirubin \\\u003C2 mg\u002Fdl without a pattern consistent with Gilbert's syndrome\n* Creatinine within normal institutional limits or creatinine clearance \\>50 mL\u002Fmin\u002F1.73 m2\n* Females of childbearing must have a negative pregnancy test at medical supervision even if had been using effective contraception\n* Life expectancy \\> 6 months\n* Able to adhere to the study visit schedule and other protocol requirements\n* Sign (or their legally acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.\n* Access to PET-CT (positron emission computed tomography) scans facilities\n\nExclusion Criteria:\n\n* Nodular Lymphocyte Predominant HL\n* Prior chemotherapy or radiation therapy\n* Pregnant or lactating females\n* Cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography.\n* Abnormal QTc (corrected QT interval) interval prolonged (\\>450 msec in males; \\>470 msec in women)\n* Uncontrolled infectious disease\n* Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc (hepatitis B core antigen) antibody and can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided\n* Uncompensated diabetes\n* Refusal of adequate contraception\n* Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.","50 Years",{"count":132,"type":20},300,[134],"PHASE3","The HL-Russia-1 is a non-randomized, open-label, multicenter, phase III, 3-arm study. The primary objective is to assess efficacy, safety and progression-free survival (PFS) of different approaches (earle favorable, early unfavorable and advanced stages) to first line chemotherapy for classical Hodgkin Lymphoma (HL).",[26],[138],"EACODD-14","2024-09-25",{"date":141,"type":35},"2024-09-27",{"date":143,"type":35},"2020-02-01",{"date":145,"type":20},"2026-12-31",{"name":147,"class":42},"State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia",2,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100391566","phase-2-brentuximab-vedotin-in-second-line-therapy-before-transplant-100391566","NCT04378647","BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant","A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy With Brentuximab Vedotin-ESHAP vs ESHAP in Patients With Relapsed \u002F Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (Instead of Autologous Hematopoietic Stem Cell Transplantation) in Those Who Attained a Metabolic Complete Remission After Salvage Therapy","BRESELIBET","Inclusion Criteria:\n\nPatients with classical HL CD30+ confirmed histologically (either at the time of diagnosis \u002F at the time of first relapse) will be included in the trial\n\n* Male or female patients 18 to 65 years of age\n* Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care\n* Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse\n* Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse\n* ECOG 0 to 2\n* Measurable disease at time of enrolment (lymphadenopathy\u002F extranodal mass of at least 1.5 cm)\n* No evidence of neuropathy grade ≥2\n* Clinical laboratory values as specified in the protocol below within 7 days before the first dose of study drug\n\nExclusion Criteria:\n\n* Lymphocyte predominant nodular Hodgkin's lymphoma\n* Prior treatment with brentuximab vedotin\n* Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.\n* Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML)\n* Symptomatic neurologic disease compromising normal activities of daily living or requiring medic\n* Any sensory or motor peripheral neuropathy greater than or equal to Grade 2\n* Known history of any of the following cardiovascular conditions defined in the protocol\n* Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose\n* Patients that have not completed any prior treatment chemotherapy and\u002For other investigational agents within at least 5 half-lives (or 28 days if the half-lives are unknown) of last dose of that prior treatment\n* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.\n* Known human immunodeficiency virus (HIV) positive\n* Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection\n* Focal radiation therapy within 30 days prior to study recruitment\n* Major surgery within 28 days prior to randomization\n* Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease.\n* Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.","65 Years",{"count":159,"type":20},150,[23],"A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed \u002F Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy",[26],"2024-02-23",{"date":165,"type":35},"2024-02-26",{"date":167,"type":35},"2020-06-01",{"date":169,"type":20},"2026-08-30",{"name":171,"class":42},"Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea",19]