[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-t-cells-lymphoma-ptcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-t-cells-lymphoma-ptcl":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,72,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100594385","phase-1-a-platform-trial-evaluating-new-drugs-or-combination-in-rr-peripheral-t-cell-lymphomas-100594385",false,"NCT07018752","A Platform Trial Evaluating New Drugs or Combination in R\u002FR Peripheral T-cell Lymphomas","A Platform Trial, Evaluating New Drugs or Combination in Relapsed or Refractory Peripheral T-cell Lymphomas","PlaTform","1. Subject who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments\u002Fprocedures being conducted;\n2. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF);\n3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements;\n4. Subject with histologically proven peripheral T-cell lymphoma according to the criteria of the WHO classification 2017 or 2022 (subjects with mycosis fungoides, Sezary syndrome, lymphoblastic or large granular lymphocytic lymphoma will be excluded). Tumor tissue (initial diagnosis or relapse) should be available for central pathology review and biological characterization;\n5. Subject in relapse\u002Frefractory situation;\n6. ECOG performance status 0 to 2, or 3 if thought to be related to lymphoma;\n7. Adequate bone marrow function as defined by:\n\n   * Absolute Neutrophil Count ≥ 1,5 x 10\\^9\u002FL (≥ 1 x 10\\^9\u002FL if related to lymphoma)\n   * Platelets ≥ 75 x 10\\^9\u002FL (≥ 50 x 10\\^9\u002FL if related to lymphoma)\n   * Hemoglobin ≥ 8 g\u002FdL;\n8. Anticipated life expectancy at least 3 months;\n9. Presence of disease specific criteria allowing response evaluation. Unless otherwise specified, such criteria include:\n\n   1. Baseline fluorodeoxyglucose PET-scan demonstrating at least one positive (FDG-avid) lesion;\n   2. and at least one bi-dimensionally measurable nodal lesion, defined as \\> 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as \\> 1.0 cm in its longest dimension;\n10. Contraception:\n\n    * For women of childbearing potential (WOCBP): must have a negative result for pregnancy test, at screening and within 24 hours prior to initiating study treatment. The WOCBP agree to abstain from becoming pregnant or breastfeeding, to remain abstinent (from heterosexual intercourse) or use at least one highly effective method of contraception and to refrain from donating eggs, during the treatment period (including periods of treatment interruption) and for at least the delay described in the sub-protocol for the concerned molecules;\n    * For men of reproductive potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use at least a condom as method of contraception with a non-pregnant female partner of childbearing potential or a pregnant female partner, and to refrain from donating sperm, during the treatment period (including periods of treatment interruption), and for at least the delay described in the sub-protocol for the concerned molecules;\n11. Subject covered by a social security system;\n12. Subject who understands and speaks one of the country official languages unless local regulation authorizes independent translators;\n\n    Additional inclusion criteria specific to Origina-ly-T sub-study:\n13. For anaplastic large cell lymphoma subjects: failed or ineligible or intolerant to brentuximab vedotin. For extranodal NK\u002FT-cells lymphoma: failed or ineligible or intolerant to asparaginase-containing regimen;\n\n    Additional inclusion criteria specific to Golcaza sub-study:\n\n13\\. Subject had local diagnosed (nodal) follicular helper T cell lymphoma according to WHO classification 2022 or ICC 2022 classification based on a surgical lymph node biopsy or needle core biopsy including any one of the following type:\n\n* angioimmunoblastic type (AITL)\n* follicular T cell type\n* not otherwise specified (NOS);\n\n  14\\. ECOG performance status 0 to 1 (supersedes criterium 6 of the Master protocol);\n\n  15\\. Subjects must have an international normalized ratio (INR) \\\u003C 1.5 x ULN and partial thromboplastin time (aPTT) \\\u003C 1.5 x ULN (for subjects not receiving therapy). Note: Subjects receiving therapy for a thromboembolic event that occurred \\> 3months prior to enrollment are eligible as long as they are on a stable regimen of anticoagulation with warfarin, low-molecular weight heparin, or other approved therapeutic anticoagulation or antiplatelet regimen;\n\n  16\\. Contraception (supersedes criterium 10 of the Master protocol):\n* For women of childbearing potential (WOCBP): must have a negative result for pregnancy test, 10 to 14 days prior to initiating study treatment and within 24 hours prior to initiating study treatment. WOCBP agree to abstain from becoming pregnant or breastfeeding and to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one highly effective method of contraception , at least 28 days before the first dose of study treatment , during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide, and 6 months after the last dose of azacitidine. Women must refrain from donating eggs during this same period;\n* For men: during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide and 3 months after the last dose of oral 5-azacitidine male subjects must:\n\n  * With female partners of childbearing potential: use a condom associated with a highly effective method of contraception or remain abstinent (refrain from heterosexual intercourse)\n  * With pregnant female partners: use a condom or remain abstinent (refrain from heterosexual intercourse) Men must refrain from donating sperm during this same period;\n\nExclusion Criteria:\n\n1. Evidence of central nervous system involvement by lymphoma;\n2. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision);\n3. Uncontrolled systemic fungal, bacterial, or viral infection;\n4. Known Hepatitis C Virus (HCV) or active Hepatitis B Virus (HBV) infection defined as subject with detectable viral load (respectively detectable viral RNA or detectable viral DNA);\n5. Active malignancy other than the one treated in this research, unless the subject has been free of the disease for 2 years (subjects with a history of a completely resected non-melanoma skin cancer or successfully treated for an in-situ carcinoma are eligible);\n6. Use of any standard or experimental anti-cancer drug therapy within 28 days or a minimum of 5 half-lives of the drug, whatever the shortest prior to first administration of study drug;.\n7. Subject taking corticosteroids within 14 days prior to first administration of study drug, unless administered at a cumulated dose equivalent of prednisone ≤ 20mg \u002Fday (within these 14 days);\n8. Subject with prior autologous hematopoietic cell transplantation (auto-HCT) ≤ 3 months prior to starting investigational product(s). If subject had autologous SCT (Stem Cell Transplant) \\> 3 months prior to the start of investigational product(s), any unresolved (Grade \\> 1) autologous SCT-related toxicity;\n9. Subject with prior allogeneic hematopoietic cell transplantation (allo-HCT) with either standard or reduced intensity conditioning ≤ 3 months prior to starting investigational product(s). If subject had allogeneic SCT \\> 3 months prior to the start of investigational product(s) and still has any unresolved situation including (Grade \\> 1) treatment-related toxicity and\u002For ongoing immunosuppressor therapy and\u002For more than mild (NIH consensus) chronic graft-versus-host disease;\n10. Subject with major surgery ≤ 14 days prior to starting investigational product(s). Subjects must have recovered from any clinically significant effects of recent surgery;\n11. Subject who has received prior localized anticancer therapy (eg. radiotherapy \\[including palliative radiotherapy\\]) ≤ 14 days prior to starting investigational product(s);\n12. Known or suspected hypersensitivity to active substance or to any of the excipients;\n13. Pregnant, planning to become pregnant, or lactating woman;\n14. Person deprived of his\u002Fher liberty by a judicial or administrative decision;\n\n    Exclusion criteria specific to Origina-ly-T sub-study:\n15. Positive HIV test at screening, with the following exception: individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to HIV within the last 12 months\n16. Impaired renal function (calculated CKP-EPI, MDRD or Cockcroft-Gault Creatinine Clearance \\\u003C 30 ml\u002Fmin) or impaired liver function tests (serum total bilirubin level \\> 34 μmol\u002FL), except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma, serum transaminases (AST or ALT) \\> 3 upper normal limits, unless elevated to up to 5 x ULN due to peripheral T-cells lymphoma);\n17. Significant cardiovascular disease \\[e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure \\| American Heart Association)\\], myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina);\n18. Prior exposure to PI3Kdelta inhibitor;\n19. Known or suspected allergies, hypersensitivity, or intolerance to Roginolisib or its excipients;\n20. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications;\n21. Subjects with a diagnosis of cutaneous T-cell lymphoma (CTCL);\n22. Prior solid organ transplantation;\n\nExclusion criteria specific to GolcAza sub-study:\n\n15\\. Evidence of positive HTLV1 serology;\n\n16\\. Positive HIV test at screening, with the following exception: individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to HIV within the last 12 months;\n\n17\\. Impaired renal function (calculated CKD-EPI, MDRD or Cockcroft-Gault Creatinine Clearance \\\u003C 30 ml\u002Fmin) or impaired liver function tests (serum total bilirubin level \\> 34 μmol\u002FL) except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma, serum transaminases (AST or ALT) \\> 3 upper normal limits (except documented liver involvement by lymphoma);\n\n18\\. Prior exposure to golcadomide;\n\n19\\. Refractory to azacitidine;\n\n20\\. Significant cardiovascular disease \\[e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure \\| American Heart Association)\\], myocardial infarction ≤ 3 months prior to starting golcadomide, unstable angina pectoris ≤ 3 months prior to starting golcadomide), or complete left bundle branch or bifascicular block), congenital long QT syndrome, QTcF ≥ 470 msec on screening, persistent or clinically meaningful ventricular arrhythmias;\n\n21\\. Received strong CYP3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers, moderate CYP3A inducers within 7 days prior to initiation of study treatment;\n\n22\\. Vaccinated with live, attenuated vaccines within 6 months of enrollment;\n\n23\\. Known or suspected allergies, hypersensitivity, or intolerance to azacitidine, golcadomide or its excipients;\n\n24\\. Any known malabsorption syndrome or disease associated with malabsorption.","ALL","18 Years",{"count":20,"type":21},49,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is a platform trial for the evaluation of new drugs or combination of drugs in relapsed or refractory peripheral T-cell lymphomas.\n\nThe objective of the study is to generate exploratory data on new drugs or combination of drugs to treat refractory\u002Frelapse peripheral T-cells lymphoma to better identify the population of interest and design future correct clinical trials.\n\nPrimary objectives of the different sub-studies :\n\n* phase 1 sub-studies: determine the safety and tolerability of escalating doses of the sub-study treatment\n* phase 2 sub-studies: identify drugs that will improve significantly the outcome in target patients Secondary objectives of both sub-studies: analyze the response rate, the clinical benefit rate, the progression-free survival, the duration of response, the time to next treatment or death, the overall survival, the rate of transplantation following study treatment and the safety profile of the drugs used",[28],"Peripheral T Cells Lymphoma (PTCL)",[30,31,32,33,34,35,36],"lymphoma","peripheral T cells lymphoma","roginolisib","azacitidine","refractory peripheral T-cells lymphoma","relapsed peripheral T-cells lymphoma","golcadomide","RECRUITING","2026-02-09",{"date":40,"type":41},"2026-02-11","ACTUAL",{"date":43,"type":41},"2025-08-20",{"date":45,"type":21},"2030-01",{"name":47,"class":48},"The Lymphoma Academic Research Organisation","OTHER",20,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100621571","phase-2-zeprumetostat-azacitidine-combined-with-lipo-mit-in-rr-ptcl-100621571","NCT07372352","Zeprumetostat, Azacitidine Combined With Lipo-MIT in R\u002FR PTCL","Clinical Study on the Efficacy and Safety of Zeprumetostat, Azacitidine Combined With Mitoxantrone Hydrochloride Liposome in Relapsed\u002FRefractory Peripheral T-Cell Lymphoma.","Inclusion Criteria:\n\n1. Relapsed or refractory peripheral T-cell lymphoma after first-line or higher treatment.\n2. Age ≥ 18 years.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.\n4. Presence of measurable target lesions \\[Note: Target lesions are defined as lesions with at least one longest diameter (LD) measurement \\> 1.5 cm and longest perpendicular diameter (LPD) measurement ≥ 1.0 cm, as assessed by computed tomography (CT) or magnetic resonance imaging (MRI). A maximum of six target lesions can be selected\\].\n5. Adequate function of major organs must meet the following criteria:\n\n   * Hematological parameters: HB ≥ 70 g\u002FL, PLT ≥ 50 × 10\\^9\u002FL, NE ≥ 1.0 × 10\\^9\u002FL (Note: Patients who have not received transfusions or drugs to support NE, PLT, or HB increase within 1 week before screening are eligible. Patients with bone marrow involvement by lymphoma resulting in cytopenia are not restricted by this criterion).\n   * Echocardiographic left ventricular ejection fraction ≥ 50%.\n   * Creatinine ≤ 132 umol\u002FL or creatinine clearance ≥ 60 ml\u002Fmin.\n   * ALT and AST ≤ 3 times the upper limit of normal.\n6. Women of childbearing potential must have a negative pregnancy test. Both male and female patients must agree to use effective contraception during treatment and for 1 year thereafter.\n7. Life expectancy of more than 3 months.\n8. Voluntary signed informed consent form.\n\nExclusion Criteria:\n\n1. Underwent major surgery or severe trauma within 2 weeks before enrollment, or significant adverse effects have not yet recovered.\n2. Currently suffering from or having had other malignancies within 3 years before enrollment, except for cured basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial neoplasia, and cervical carcinoma in situ.\n3. History of stroke or intracranial hemorrhage within the past 3 months.\n4. Presence of complications or medical conditions that may interfere with the conduct of the study or pose a significant risk to the patient, including but not limited to severe cardiovascular diseases (e.g., cardiac disease classified as New York Heart Association class III or IV, myocardial infarction within the past 6 months, unstable arrhythmias, or unstable angina) and\u002For severe pulmonary diseases (e.g., severe obstructive pulmonary disease and history of symptomatic bronchospasm).\n5. Human immunodeficiency virus infection, or presence of uncontrollable active hepatitis C virus or hepatitis B virus infection.\n6. Uncontrollable active infection.\n7. Pregnant or breastfeeding women.\n8. Any life-threatening disease, medical condition, or organ system dysfunction that may endanger the safety of the patient, as determined by the investigator.\n9. Any condition that may interfere with the absorption or metabolism of zemtovistat, azacitidine, or doneda, or place the study results at unnecessary risk.\n10. Lymphoma involvement of the central nervous system.\n11. Presence of conditions judged by the investigator to interfere with full participation in the study; conditions posing significant risk to the subject; or conditions that may interfere with the interpretation of study data.",{"count":58,"type":21},26,[25],"This clinical trial is a Phase II study investigating the effectiveness and safety of a three-drug combination-Zeprumetostat, Azacitidine, and Mitoxantrone Hydrochloride Liposome-in adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL is an aggressive type of non-Hodgkin lymphoma that has limited treatment options after the first line of therapy.\n\nThe study aims to enroll approximately 26 patients at a single center in China. Eligible participants will receive up to 6 cycles of induction therapy with all three drugs, followed by up to 2 years of maintenance therapy with Zeprumetostat alone if they respond to treatment.\n\nThe main goal is to evaluate the overall response rate (how many patients experience tumor shrinkage). Secondary goals include assessing how long patients live without their disease getting worse, how long they survive overall, and the safety profile of this treatment combination. The study will also explore whether specific genetic markers or viral infections are linked to how well patients respond.\n\nThis study is important because it tests a novel, potentially less toxic, and more effective combination for a patient population with high unmet medical need. All participants will be closely monitored for treatment response and side effects throughout the trial.",[28],"2026-01-19",{"date":64,"type":41},"2026-01-28",{"date":66,"type":21},"2026-01-15",{"date":68,"type":21},"2029-07-15",{"name":70,"class":48},"The First Affiliated Hospital of Soochow University",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100603656","phase-1-linperlisib-combined-with-chidamide-in-the-treatment-of-relapsed-or-refractory-peripheral-t-cell-lymphoma-100603656","NCT07139353","Linperlisib Combined With Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma","Linperlisib Combined With Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma: A Prospective, Multicenter, Open-label, Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;\n* Diagnosed with PTCL according to the 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center\n* Using the Lugano 2014 lymphoma efficacy evaluation criteria, the patient must have at least one measurable or evaluable lesion\n* Treatment failure to at least one prior line of systemic standard therapy for PTCL.\n* Age ≥ 18 years\n* Expected survival greater than 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Accompanied by hemophagocytic lymphohistiocytosis (HLH)\n* Lymphoma involvement in the central nervous system or meninges\n* Active infections\n* Uncontrolled clinical cardiac symptoms or diseases\n* Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.\n* Currently using vitamin K antagonists, antiplatelet drugs, anticoagulants (or unable to stop them within one week prior to the start of the study treatment).\n* History of Human Immunodeficiency Virus (HIV) infection and\u002For Acquired Immunodeficiency Syndrome (AIDS).\n* Patients with mental disorders or those unable to provide informed consent",{"count":80,"type":21},54,[24,25],"This is a prospective, multicenter, open-label, phase Ib\u002FII clinical study to evaluate the safety and efficacy of linperlisib combined with chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma",[28],"NOT_YET_RECRUITING","2025-08-21",{"date":87,"type":41},"2025-08-24",{"date":89,"type":21},"2025-09-15",{"date":91,"type":21},"2029-09-01",{"name":93,"class":48},"Sun Yat-sen University",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100554179","phase-1-polyspecific-antibodies-in-lymphoproliferative-t-cell-disorders-100554179","NCT06495723","Polyspecific Antibodies in Lymphoproliferative T-cell Disorders","Phase I\u002FII, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of Glyco-humanized Polyclonal Antibody Directed Against Tumoral T Cells, in Patients With Relapsed\u002FRefractory Peripheral T Cells Lymphoma (PTCL)","PALT1","Inclusion Criteria:\n\n1. Provide signed, written informed consent.\n2. Is male or female, age ≥18 years old (at the time consent is obtained)\n3. For Part 1: Has a histological diagnosis of the following relapsed or refractory PTCL based on WHO 2022 classification of lymphoid neoplasms\n\n   * Intestinal T-cell and NK cell lymphoid proliferations and lymphomas (without NK cell neoplasms)\n   * Hepatosplenic T-cell lymphoma\n   * Anaplastic large cell lymphoma\n   * Nodal TFH cell lymphoma\n   * Other peripheral t-cell lymphomas For Part 2: The type of PTCL will be defined based on SC review after completion of Part 1 and will be documented in the protocol amendment\n4. Had previously received 1 or more appropriate systemic therapies, including an alkylating agent and\u002For anthracycline, for treatment of the current disease (radiation therapy alone would not be acceptable as previous therapy). Participants with ALCL must have received prior brentuximab vedotin or be unable to receive it due to allergy or intolerance.\n5. Experienced disease progression during or after completion of most recent therapy or refractory disease.\n6. Has a measurable lesion by imaging: the longest diameter should be ≥1.5 cm for nodal lesions and \\>1 cm for extra-nodal lesions.\n7. Experienced a toxicity of prior therapy: Participants must have recovered to less than Grade 1 or to baseline from toxicity of prior chemotherapy or biologic therapy and must not have had major surgery, chemotherapy, radiation, or biologic therapy within 2 weeks prior to beginning treatment.\n\n   Note: Exceptions to this include events not considered to place the participant at unacceptable risk of participation in the opinion of the Investigator (e.g., alopecia).\n8. Has either unstained tissues (block or unstained slides) or stained slides and pathology report available for central review. If stained slides or unstained tissue are not available or insufficient, a fresh tumor tissue sample is mandatory for central pathology. Central pathology confirmation is not required prior to enrollment.\n9. Is able to provide a bone marrow aspirate and\u002For a biopsy no older than 3 months at screening and agrees to undergo post-treatment bone marrow aspirate or biopsy when required to confirm response.\n10. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n11. Has life expectancy of \\>3 months.\n12. Has an adequate hematological and organ function at screening, including:\n\n    * Hemoglobin ≥8.0 g\u002FdL (prior transfusion is acceptable)\n    * Absolute neutrophil count (ANC) ≥1000 cells\u002Fmm3 (without growth factor support within 7 days of ANC measurement)\n    * Platelet count ≥50,000 cells\u002Fmm3 (without growth factor support or transfusion within 7 days of platelets measurement)\n    * Creatinine clearance ≥30 mL\u002Fmin\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C3 × the upper limit of normal (ULN)\n    * Serum total bilirubin \\\u003C2 × ULN OR \\\u003C3 × ULN (for participants with Gilbert's Syndrome)\n13. Participants must be able to understand and sign an informed consent form.\n14. All participants must use adequate contraception during participation in this study and for 6 months following completing therapy.\n\nExclusion Criteria:\n\n1. Is diagnosed with a bulky disease (≥10 cm).\n2. Has known history or presence of central nervous system involvement by leukemia or lymphoma.\n3. Has Mature T-cell and NK-cell leukemias (WHO 2022 criteria)\n4. Has T-lymphoblastic leukemia\u002Flymphoma (WHO 2022 criteria)\n5. Has tumor-like lesions with T-cell predominance (WHO 2022 criteria)\n6. Has Primary cutaneous T-cell lymphomas (WHO 2022 criteria)\n7. Has any other active cancers, or history of treatment for invasive cancer ≤3 years.\n\n   Note: Participants with stage I cancer who have received definitive local treatment at least 3 years previously and are considered unlikely to recur are eligible. All participants with previously treated in situ carcinoma (i.e., non-invasive) are eligible.\n8. Received any of the following treatments prior to the first dose of study medication:\n\n   * Systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks (or 5 half-lives, whichever is shorter) before Cycle 1 Day 1. Participants that received local radiation therapy are eligible.\n   * Therapeutic anti-cancer antibodies \\\u003C4 weeks\n   * Any investigational drug in the last 4 weeks prior\n   * Any major surgery or immunotherapy within 28 days\n   * Toxin immunoconjugates \\\u003C4 weeks\n   * Nitrosoureas \\\u003C6 weeks\n   * Allogeneic hematologic stem cell transplant within 3 months\n   * Adaptive cellular therapy such as autologous or donor natural killer cell or T lymphocyte infusions within 90 days\n   * Systemic corticosteroids (prednisone or equivalent \\>10 mg daily) within 2 weeks prior to the start of therapy, or 12 weeks if given to treat graft versus host disease (GVHD), except for physiological replacement doses of cortisone acetate or equivalent\n   * Systemic treatment for GVHD (including but not limited to oral or parenteral corticosteroids, ibrutinib, and extracorporeal phototherapy) within the last 12 weeks\n9. Is experiencing a toxicity (or AE) from prior anti-cancer treatment that has not resolved to Grade ≤1 or baseline.\n10. Has a known infection with human immunodeficiency virus (HIV) or serologic status reflecting active hepatitis B or C infection as follows:\n\n    * Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible only if hepatitis B virus (HBV) DNA is undetectable by an assay with sensitivity \\\u003C20 IU\u002FmL. If so, participants may either undergo regularly scheduled monitoring of HBV DNA or less frequent monitoring of HBV DNA while on prophylactic antiviral medication as defined by regional standard of care.\n    * Presence of hepatitis C virus (HCV) antibody. Participants with presence of HCV antibody are eligible only if HCV RNA is undetectable.\n11. Has a known active tuberculosis infection.\n12. Has an active fungal, bacterial, and\u002For viral infection requiring systemic therapy.\n13. Had a vaccination with a live vaccine within 35 days prior to the first dose of LIS1.\n14. If woman, is pregnant or nursing a child.\n15. Has an active autoimmune disease or history of autoimmune disease that may relapse except for type I diabetes under control, hypothyroidism managed with hormone replacement therapy, controlled celiac disease, and skin disease (vitiligo, psoriasis, etc.) not requiring systemic treatment.\n16. Has a known history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung disease, or dyspnea at rest or pulse oxymetrie \\\u003C 92% at room air.\n17. Has a clinically significant cardiovascular disease including the following:\n\n    * Myocardial infarction or unstable angina within 3 months before screening\n    * Congestive heart failure (New York Heart Association functional classification III-IV)\n    * History of clinically significant arrythmias\n    * QTcF \\> 470 msec\n    * History of Mobitz II second degree or third-degree heart block without a permanent pacemaker in place\n    * Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \\>170 mm Hg and diastolic blood pressure \\>105 mmHg at screening\n18. Has a cognitive impairment, active substance abuse, or psychiatric illness or social situations that, in the view of the Investigator, would preclude safe treatment or the ability to give informed consent and limit compliance with study requirements.\n19. Has a known history of drug-induced liver injury, alcoholic liver disease, non- alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension.\n20. Has a hemophilia or von Willebrand's disease.\n21. Has any psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.\n22. Has a concurrent condition that, in the Investigator's opinion, would jeopardize compliance with the protocol.\n23. Are unable or unwilling to comply with study and\u002For follow-up procedures outlined in the protocol.\n24. For France, participants under legal protection (safeguard, guardianship, curatorship).\n25. Is currently participating in another therapeutic clinical study.\n26. Has a known hypersensitivity to polyclonal antibody.",{"count":80,"type":21},[24,25],"This is a 2-part study consisting of a Part 1, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), or Recommended Part 2 Dose (RP2D) of LIS1 as a single agent; followed by a Part 2, to investigate anti-tumors efficacy of LIS1 in selected subtypes of Peripheral TCell Lymphoma (PTCL) and to further evaluate its safety and tolerability at RP2D.",[28],[107],"Relapsed Refractory PTCL","2025-07-21",{"date":110,"type":41},"2025-07-22",{"date":112,"type":41},"2024-07-09",{"date":114,"type":21},"2027-07-31",{"name":116,"class":117},"Xenothera SAS","INDUSTRY",8]