[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dlbcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dlbcl":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,48,72,96,123,148,195,218,254,296,317,339,363,386,415,439,461,484,506,526,549,570,591,610,632],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100362726","phase-2-acalabrutinib-with-da-epoch-r-or-r-chop-for-people-with-untreated-diffuse-large-b-cell-lymphoma-100362726",false,"NCT04002947","Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma","A Phase 2 Study of Acalabrutinib With DA-EPOCH-R or R-CHOP for Patients With Untreated Diffuse Large B-cell Lymphoma","-INCLUSION CRITERIA:\n\n1. Patients must have a confirmed histologic diagnosis of an aggressive B-cell lymphoma with morphologic appearance of DLBCL or high-grade B-cell lymphoma (HGBL) confirmed by the Laboratory of Pathology, NCI, with no prior treatment for DLBCL or HGBL. The following subtypes are included:\n\n   * DLBCL, NOS, Activated B-cell type (ABC)\n   * DLBCL, NOS, Germinal center B-cell type (GCB)\n   * T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n   * Primary cutaneous DLBCL, leg-type\n   * EBV+ DLBCL, NOS\n   * DLBCL associated with chronic inflammation\n   * ALK+ large B-cell lymphoma\n   * High-grade B-cell lymphoma, NOS\n   * High-grade B-cell lymphoma, with MYC and BCL2 and\u002For BCL6 rearrangements\n\n   NOTE: Presence of concomitant indolent lymphomas such as follicular lymphoma, marginal zone lymphomas, monoclonal B-cell lymphocytosis or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma that are best categorized as composite or transformed lymphomas are allowed.\n2. A formalin-fixed tissue block or 15 slide of tumor sample (archival or fresh) must be available for performance of correlative studies.\n\n   NOTE: Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator. Patients must be willing to have a tumor biopsy if adequate archival tissue is not available (i.e., post-enrollment and prior to treatment).\n3. Measurable lymph nodes or masses of at least 1.5 centimeters (cm) on baseline CT or MRI\n4. Stage II, III, or IV disease as classified by the Ann Arbor Classification\n5. Age greater than or equal to 18 years\n6. ECOG performance status less than or equal to 2.\n7. Adequate organ and marrow function as defined below unless dysfunction is felt to be secondary to lymphoma involvement as determined by the treating investigator:\n\n   * absolute neutrophil count\\* \\>=1,000\u002FmcL\n   * hemoglobin\\* \\>= 8 g\u002FdL (transfusions permitted to meet criteria)\n   * Platelets \\>= 75,000\u002FmcL (transfusions not permitted)\n   * total bilirubin \\\u003C= 1.5 X institutional ULN (or \\\u003C= 3 X institutional ULN for patients with documented Gilberts syndrome or cholestatic obstruction or involvement by lymphoma)\n   * AST(SGOT)\u002FALT(SGPT) \\\u003C= 3 X institutional ULN (\\\u003C= 5 x ULN for patients with cholestatic obstruction or involvement by lymphoma\n   * Serum creatinine \\\u003C= 2.0 mg\u002FdL\n\n   OR\n\n   -Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above 2 mg\u002FdL\n\n   \\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters.\n\n   NOTE: In patients without bone marrow involvement, transfusions of RBCs are permitted to achieve the criterion hemoglobin of 8g\u002Fdl, but transfusions of platelets are not permitted to achieve the criterion platelet count of \\>75,000\u002FmcL. In patients with bone marrow involvement, all transfusions are permissible at the discretion of the investigator.\n8. Effects of acalabrutinib on the developing human fetus are unknown. For these reasons the following measures apply:\n\n   * Individuals of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment.\n   * Individuals of childbearing potential who are sexually active must agree to highly effective contraception prior to study entry, for the duration of study participation, and for at least 2 days after the last dose of acalabrutinib or 12 months after the last dose of combined chemotherapy, whichever is later. Individuals who can father children must use highly effective contraception prior to study entry, for the duration of study participation, and for 12 months after the last dose of combined chemotherapy; there is no contraception timing requirement post-last dose of acalabrutinib alone if an individual who can father children does not initiate chemotherapy on study after the acalabrutinib window.\n   * Participants must not be planning to conceive or father children within the projected duration of the trial, starting with the pre-screening\u002Fscreening visit through 2 days after the last dose of acalabrutinib or 12 months after the last dose of combined chemotherapy, whichever is later.\n\n   NOTE: An individual is considered of childbearing potential, (i.e., fertile), following menarche and until becoming post-menopausal unless permanently sterile or have a congenital or acquired condition that prevents childbearing. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy at least 6 weeks before screening. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. In individuals of childbearing potential \\\u003C45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in individuals of childbearing potential not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient The investigator or a designated associate is requested to advise the subject how to achieve highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence.\n\n   Individuals who can father children are considered to be of non-reproductive potential if they are permanently sterile due to bilateral orchiectomy.\n\n   Highly effective methods of contraception (to be used during heterosexual activity) are defined as methods that can achieve a failure rate of \\\u003C1% per year when used consistently and correctly. Such methods include:\n   * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal\n   * Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable\n   * Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)\n   * Bilateral tubal occlusion\n   * Vasectomy of participant or participant's partner (with medical assessment and confirmation of vasectomy surgical success)\n   * Sexual abstinence (only if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments)\n\n   Hormonal contraception may be susceptible to interaction with study or other drugs, which may reduce the efficacy of the contraception method.\n\n   Abstinence (relative to heterosexual activity) can only be used as the sole method of contraception if it is consistently employed during the entire period of risk associated with the study treatments.\n\n   Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, and post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n9. Ability of patient to understand and the willingness to sign a written informed consent document.\n10. Any HIV status will be included in this study; status must be confirmed prior to enrollment.\n\nEXCLUSION CRITERIA:\n\n1. Patients who meet histologic criteria for the following subtypes are excluded:\n\n   * Primary DLBCL of the central nervous system (PCNSL)\n   * Primary mediastinal B-cell lymphoma (PMBL)\n   * Plasmablastic lymphoma\n   * Intravascular large B-cell lymphoma\n   * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n2. Patients who, at the discretion of the investigator, need immediate cytoreductive chemotherapy such as patients with evidence of spontaneous tumor lysis or impending organ compromise are not eligible.\n3. Current or prior anti-cancer treatment for DLBCL prior to enrollment. Short course of corticosteroids (\\\u003C7 days) for acute issues prior to study enrollment are permitted.\n4. Major surgical procedure within 30 days of first dose of study drug. If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n5. Requires treatment with moderate or strong CYP3A inhibitors or inducers\n6. Known lymphomatous involvement of the CNS\n7. Pregnant individuals, or individuals who intend to become pregnant during the study are excluded from this study because of potential teratogenic effects associated with acalabrutinib, R-CHOP, and\u002For DA-EPOCH-R\n8. The potential for all study treatments to be excreted in the milk of nursing mothers is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with acalabrutinib, nursing must be discontinued.\n9. Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\n\n   -Other malignancy that requires ongoing systemic hormonal therapy, chemotherapy, or immunotherapy.\n\n   Uncontrolled active systemic infection\n   * Any condition that requires anticoagulation with warfarin or equivalent vitamin K antagonist\n   * Active bleeding, history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)\n   * Suspected or confirmed Progressive Multifocal Leukoencephalopathy (PML)\n   * Active hepatitis C infection. NOTE: Subjects who are hepatitis C antibody positive will need to have a negative HCV PCR result before enrollment. Those with a positive PCR for hepatitis C are excluded.\n   * Active hepatitis B infection. NOTE: Patients who are hepatitis B surface antigen (HbsAg) positive will be excluded from enrollment. Patients who are hepatitis B core antibody (HbcAb) positive will need to have a negative HBV PCR result before enrollment. Those with a positive PCR for hepatitis B are excluded. Those who are hepatitis B core antibody (HbcAb) positive with a negative PCR for hepatitis B will be treated with antivirals designed to prevent hepatitis B reactivation (e.g., entecavir) throughout therapy and for 12 months after therapy and have monitoring for hepatitis B reactivation with PCR.\n   * History of hemorrhagic stroke or intracranial hemorrhage in preceding 6 months\n   * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled atrial fibrillation\u002Fflutter during screening are eligible.\n   * Uncontrolled autoimmune hemolytic anemia\n   * Inability to swallow oral medications, or disease involve that significantly limits absorption of oral medication\n   * Known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the results of the trial and, in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n10. Concurrent participation in another therapeutic clinical trial.","ALL","18 Years",{"count":19,"type":20},132,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\nDiffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Most people with this cancer can be cured. But those who are not cured have a poor prognosis. Researchers want to add another drug to standard treatment see if it can improve the cure rate.\n\nObjective:\n\nTo see if the drug acalabrutinib given with rituximab and standard combination chemotherapy can improve the cure rate of aggressive B-cell lymphomas such as diffuse large B-cell lymphoma.\n\nEligibility:\n\nPeople ages 18 and older with an aggressive B-cell lymphomas that have not been treated\n\nDesign:\n\nParticipants will be screened with:\n\nBlood and urine tests\n\nPhysical exam\n\nMedical history\n\nTumor biopsy\n\nBone marrow biopsy: A needle will remove marrow from the participant s hipbone.\n\nLumbar puncture: If necessary, a needle will remove fluid from the participant s spinal canal.\n\nImaging scans\n\nParticipants will take the study drug for up to 14 days. It is a pill taken 2 times a day. Then they will have more scans. They will get rituximab and chemotherapy. They may get these drugs through a needle in an arm vein. Or they may them through a tube placed in a vein in their chest or in their neck. They might also keep taking the study drug. Each treatment cycle lasts 21 days. They will have up to 6 cycles.\n\nParticipants may have 4 doses of another drug injected into their spinal fluid.\n\nParticipants will have repeats of the screening tests throughout the study.\n\nParticipants will have a follow-up visit 30 days after their last treatment, then every 3 months for 2 years, then every 6 months for 3 years, and then yearly.",[26,27,28,29],"Non-Hodgkin's Lymphoma","Diffuse Large B-Cell Lymphoma","DLBCL","NHL",[31,32,33,34],"BTK Inhibitor","Calquence","ACP-196","Monoclonal Antibody","RECRUITING","2026-06-27",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2019-08-05",{"date":43,"type":20},"2031-03-31",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100449940","phase-2-a-study-of-zilovertamab-vedotin-mk-2140-in-combination-with-standard-of-care-in-participants-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-rrdlbcl-mk-2140-003-100449940","NCT05139017","A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)","A Phase 2\u002F3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)","Inclusion Criteria:\n\n* Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).\n* Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator.\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.\n* Has adequate organ function.\n* Is able to provide new or archival tumor tissue sample not previously irradiated.\n\nZilovertamab vedotin plus R-GemOx, or R-GemOx study arms:\n\n* Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy.\n* Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy.\n\nNot applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms:\n\n* Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least 2 lines of prior therapy.\n* Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy.\n\nExclusion Criteria:\n\n* Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL\n* Has received solid organ transplant at any time.\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).\n* Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication.\n* Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.\n* Has clinically significant pericardial or pleural effusion.\n* Has ongoing Grade \\>1 peripheral neuropathy.\n* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n* Has a demyelinating form of Charcot-Marie-Tooth disease.\n* Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction.\n* Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.\n* Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has ongoing corticosteroid therapy.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n* Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease), and clinical remission.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known active Hepatitis C virus infection.\n* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.",{"count":56,"type":20},290,[23,58],"PHASE3","The purpose of this Phase 2\u002F3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR.\n\nWith protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \\[BR\\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.",[28,27],"2026-06-18",{"date":63,"type":39},"2026-06-23",{"date":65,"type":39},"2022-01-14",{"date":67,"type":20},"2027-09-24",{"name":69,"class":70},"Merck Sharp & Dohme LLC","INDUSTRY",134,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":47},"100642145","phase-1-single-arm-clinical-study-of-ezh2i-in-combination-with-glofitamab--gemox-in-patients-with-relapsed-refractory-dlbcl-100642145","NCT07643805","Single-Arm Clinical Study of EZH2i in Combination With Glofitamab + GemOx in Patients With Relapsed\u002F Refractory DLBCL","A Prospective, Single-Arm, Phase Ib\u002FII Clinical Study of the EZH2 Inhibitor in Combination With Glofitamab Plus GemOx for the Treatment of Relapsed\u002FRefractory DLBCL","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female;\n2. Histologically confirmed diffuse large B-cell lymphoma (DLBCL);\n3. Relapsed\u002Frefractory (R\u002FR) disease；\n4. At least one prior line of therapy containing rituximab;\n5. Subjects must have at least one measurable lesion;\n6. ECOG PS 0-2;\n7. Life expectancy ≥ 3 months;\n8. Adequate organ and bone marrow function, without severe hematopoietic abnormalities or cardiac, pulmonary, hepatic, renal, thyroid dysfunction, or immunodeficiencies;\n9. Female subjects of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of study drug; WOCBP subjects and male subjects with WOCBP partners must agree to practice effective contraceptive measures from the time of signing the informed consent form (ICF) until 6 months after the last dose of study drug;\n10. Signed informed consent form (ICF), voluntarily agreeing to participate in this study.\n\nExclusion Criteria:\n\n1. Patient is a candidate for hematopoietic stem cell transplantation.\n2. Prior allogeneic hematopoietic stem cell transplantation.\n3. Primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma.\n4. History of severe hypersensitivity or anaphylactic reaction to humanized or murine monoclonal antibodies.\n5. Prior treatment with an EZH2 inhibitor, and\u002For an anti-CD20 and CD3 bispecific antibody, and\u002For GemOx (gemcitabine and oxaliplatin).\n6. History of other malignancies within the past 2 years requiring systemic therapy.\n7. Receipt of systemic anti-neoplastic therapy, including chemotherapy, immunotherapy, biologic therapy, etc., within 14 days prior to the start of study treatment.\n8. Major surgery (excluding diagnostic procedures) within 28 days prior to the start of study treatment.\n9. Presence of any active, known, or suspected autoimmune disease. (Subjects who are in a stable condition and do not require systemic immunosuppressive therapy are permitted to enroll.)\n10. Use of immunosuppressive agents, including systemic corticosteroids, within 14 days prior to study drug administration (use of ≤10 mg\u002Fday prednisone or equivalent is permitted).\n11. Any active infection requiring systemic anti-infective therapy within 14 days prior to the start of study treatment.\n12. Presence of any uncontrolled comorbid conditions that may affect compliance with the study protocol, including major cardiovascular disease, bleeding disorders, etc.\n13. Active hepatitis B virus (HBV) infection (HBV DNA positive) or hepatitis C virus (HCV) infection.\n14. Known history of human immunodeficiency virus (HIV) positivity.\n15. Inability to swallow oral medication, or any other factor affecting oral drug administration and absorption.\n16. Known history of hypersensitivity to the study drug.\n17. Pregnant or breastfeeding women.\n18. Any other condition deemed inappropriate for inclusion by the investigator.",{"count":80,"type":20},46,[82,23],"PHASE1","Single-Arm Clinical Study of Zeprumetostat in Combination with Glofitamab + GemOx in Patients with Relapsed\u002F Refractory DLBCL",[28],"NOT_YET_RECRUITING","2026-06-09",{"date":88,"type":39},"2026-06-12",{"date":90,"type":20},"2026-06-01",{"date":92,"type":20},"2030-09-30",{"name":94,"class":95},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":47},"100612860","phase-1-multicenter-single-arm-exploratory-phase-i-clinical-study-assessment-of-safety-and-efficacy-of-fully-human-baff-r-chimeric-antigen-receptor-t-cell-injection-in-relapsedrefractory-baff-r-positive-b-cell-lymphoma-100612860","NCT07259070","Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Multicenter, Single-Arm Exploratory Phase I Clinical Study on the Safety and Efficacy of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Participants With Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Inclusion Criteria:\n\n1.Relapsed and refractory (R\u002FR) BAFF-R-positive B-cell lymphoma:The diagnosis of B-cell lymphoma must be confirmed in accordance with the NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (Version 1.2020) (NCCN: National Comprehensive Cancer Network).The expression of BAFF-R on tumor cells must be detected by flow cytometry (for patients where current clinical sampling is not feasible, test results obtained within 90 days prior to signing the informed consent form are acceptable). Investigators will determine whether to accept test results from external hospitals and whether the patient is eligible for enrollment.In accordance with the 2014 Lugano Classification, B-cell lymphoma patients must have at least one measurable lesion with a longest diameter ≥ 1.5 cm, or bone marrow involvement confirmed by bone marrow flow cytometry.Patients who have received CD19-targeted therapy are also eligible for enrollment, including those who have undergone:\n\n1. :Relapsed and refractory (R\u002FR) mantle cell lymphoma (MCL):Histologically confirmed MCL;Relapsed or refractory after at least 2 lines of prior treatment (including anti-CD20 monoclonal antibody and Bruton's tyrosine kinase inhibitor \\[BTKi\\]).\n2. :Relapsed and refractory (R\u002FR) chronic lymphocytic leukemia (CLL):Histologically confirmed CLL;Patients who have received at least immunochemotherapy and are refractory to both BTK inhibitors and B-cell lymphoma 2 (BCL2) inhibitors.\n3. :Relapsed and refractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL):Histologically confirmed DLBCL;Patients who have received anthracycline-based therapy and anti-CD20 monoclonal antibody therapy, and have undergone at least 2 lines of treatment in total; or patients who failed to achieve remission, progressed, or relapsed within 12 months after initial standard treatment.\n4. :Relapsed and refractory (R\u002FR) follicular lymphoma (FL):Histologically confirmed FL (Grade 1-3a);Patients who have received anti-CD20 monoclonal antibody-containing therapy and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n5. :Relapsed and refractory (R\u002FR) marginal zone lymphoma (MZL):Histologically confirmed MZL;Patients who have received anti-CD20 monoclonal antibody-containing therapy, have undergone at least 2 lines of treatment in total and relapsed thereafter; or patients who relapsed within 24 months after initial treatment.\n6. :Relapsed and refractory (R\u002FR) Waldenström macroglobulinemia (WM):Histologically confirmed WM;Patients who have received anti-CD20 monoclonal antibody-containing therapy and BTK inhibitor-containing therapy (among other medications), and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n\n2.Aged ≥ 18 years and ≤ 75 years, with no restriction on gender. 3.Expected survival time ≥ 12 weeks. 4.Serum total bilirubin ≤ 37.2 μmol\u002FL (for patients with Gilbert syndrome: serum total bilirubin ≤ 3.0 × upper limit of normal \\[ULN\\], direct bilirubin ≤ 1.5 × ULN); estimated glomerular filtration rate \\[eGFR\\] (calculated by CKD-EPI formula) ≥ 30 ml\u002Fmin\u002F1.73m²; alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] \\\u003C 2.5 × upper limit of normal \\[ULN\\].\n\n5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6.Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography; oxygen saturation \\> 91%.\n\n7.The participant and their spouse\u002Fpartner must agree to use effective barrier or pharmaceutical contraceptive methods from the time the participant signs the informed consent form until one year after CAR-T cell infusion. For female participants of childbearing potential, serum or urine pregnancy test results must be negative during the screening period.\n\n8.Voluntarily participate in this trial and sign the Informed Consent Form (ICF).\n\n1. ： The patient has a full understanding of this study, voluntarily agrees to participate, and signs the Informed Consent Form (ICF).\n2. ：Aged ≥ 18 years and ≤ 75 years, with no restriction on gender.\n\nExclusion Criteria:\n\n1. Patients with a history of allergy to any component of the cellular product.\n2. Patients with acute graft-versus-host disease (aGVHD) graded as Grade II-IV according to the Glucksberg criteria, or with severity graded as Grade B-D according to the IBMTR index; patients with acute or chronic graft-versus-host disease (cGVHD) requiring systemic treatment within 4 weeks prior to enrollment.\n3. Participants who have received a live vaccine injection within 4 weeks prior to enrollment.\n4. Patients with central nervous system (CNS) diseases unrelated to lymphoma central nervous system involvement (e.g., cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, psychiatric disorders, etc.). Lymphoma central nervous system involvement or gastrointestinal tract involvement is not an exclusion criterion, but eligibility for enrollment shall be determined by the investigator.\n5. Patients with severe active infections (except uncomplicated urinary tract infections and bacterial pharyngitis), or those currently receiving intravenous antibiotic therapy. However, prophylactic use of antibiotics, antiviral drugs, and antifungal drugs is permitted.\n6. Patients who are positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B virus (HBV) DNA in peripheral blood.\n7. Patients who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood.\n8. Patients with other acquired or congenital immunodeficiency diseases, including but not limited to those positive for human immunodeficiency virus (HIV) antibody; patients with cytomegalovirus (CMV) DNA test value \\> 400 copies\u002FmL; patients with positive syphilis test results.\n9. Patients with heart failure classified as Grade III or IV according to the New York Heart Association (NYHA) Functional Classification (see Appendix II).\n10. Patients with a history of other primary malignancies, except for the following cases:Non-melanoma skin cancer (e.g., basal cell carcinoma of the skin) cured by resection;In situ carcinoma cured (e.g., cervical cancer, bladder cancer, breast cancer, etc.);Other primary malignancies with no recurrence detected for more than 5 years after treatment.\n11. Patients with a history of solid organ transplantation.\n12. Patients with a history of autoimmune diseases (predominantly characterized by abnormal cellular immunity), as well as patients with immunodeficiency or those requiring immunosuppressive therapy.\n13. Patients who received investigational drugs from other interventional clinical trials within 3 months prior to signing the Informed Consent Form (ICF).\n14. Pregnant women or women who are breastfeeding.\n15. Patients with psychiatric disorders, consciousness disturbances, or central nervous system (CNS) diseases.\n16. Patients whose toxic effects from prior treatment have not resolved to baseline or ≤ Grade 2 (per NCI-CTCAE Version 5.0, alopecia excluded).\n17. Medication use:Corticosteroids: Use of therapeutic-dose corticosteroids within 72 hours prior to CAR-T cell infusion; however, physiological-dose corticosteroid replacement is permitted (hydrocortisone \\\u003C 12 mg\u002Fm²\u002Fday or its equivalent dose)；Systemic antineoplastic therapy: Failure to discontinue systemic antineoplastic therapy for at least 2 weeks or 5 drug half-lives prior to T cell apheresis (except for BTK inhibitors in patients with CLL); the interval between T cell apheresis and the use of immune checkpoint inhibitors is less than 3 drug half-lives.\n18. Patients with active pulmonary infections.\n19. Patients with contraindications to peripheral blood apheresis.\n20. Patients deemed unsuitable for participation in this trial by the investigator after careful consideration for other reasons.","75 Years",{"count":105,"type":20},20,[82,23],"The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD).\n\nThe secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma.\n\nThe study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.",[28,109,110,111,112,113],"CLL","FL","MCL","WM","MZL","2026-05-10",{"date":116,"type":39},"2026-05-13",{"date":118,"type":39},"2025-11-29",{"date":120,"type":20},"2029-11-28",{"name":122,"class":95},"Institute of Hematology & Blood Diseases Hospital, China",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100636771","phase-1-a-study-of-rocbrutinib-combined-with-r-gemox-in-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-100636771","NCT07570017","A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma","A Phase Ib Study to Evaluate the Safety and Efficacy of Rocbrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin (R-GemOx) in Patients With Refractory or Relapsed Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Patients with relapsed or refractory non-GCB DLBCL.\n* Have at least one measurable lesion according to the Lugano Response Criteria 2014.\n* ECOG performance status 0-2 (0-1 for dose escalation part).\n* Life expectancy ≥ 12 weeks.\n* Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.\n* No plan for autologous\u002Fallogeneic hematopoietic stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy.\n* Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.\n* All male subjects and female subjects of childbearing potential must strictly use medically approved contraception throughout the entire study period. All male subjects must also avoid sperm donation during the above period. For women of childbearing potential, the result of serum pregnancy test must be obtained. Women must be non-lactating\n* Subjects must provide adequate tissue and blood samples for exploratory study. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.\n\nExclusion Criteria:\n\n* Intolerance to Rocbrutinib or any drug in the combination regimen.\n* Prior treatment with a BTK-targeted therapy; prior treatment with R-GemOx.\n* DLBCL transformed from an indolent lymphoma; diagnosis of high-grade or double-hit DLBCL.\n* Chemotherapy, biologic therapy (except CAR-T), immunotherapy or major surgery within 4 weeks of the first dose of study treatment.\n* Small molecule targeted therapy within 4 weeks or within 5 half-lives (whichever is shorter) of the first dose of study treatment.\n* Herbal or proprietary Chinese medicines with antitumor activity or radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment.\n* History of allogeneic hematopoietic stem-cell transplantation (allo-HSCT) or other organ transplantation, or autologous HSCT (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days of the first dose of study treatment.\n* Current corticosteroid therapy at a dose \\>20 mg\u002Fday prednisone equivalent. The prednisone-equivalent dose must have been stable for at least 4 weeks before Cycle 1 Day 1.\n* Unable to discontinue prohibited medications during the study period (strong or moderate CYP3A inhibitors or inducers, P-gp inhibitors, OATP1B3-sensitive substrates, warfarin or other vitamin K antagonists).\n* Known or suspected CNS involvement by lymphoma.\n* Presence of peripheral neuropathy \\> Grade 1.\n* Any severe and\u002For uncontrolled systemic disease, or condition affecting drug swallowing or absorption, that in the investigator's judgment makes the subject unsuitable for the study.",{"count":131,"type":20},42,[82],"This is a multicenter, open-label phase Ib study, evaluating the safety, tolerability, preliminary efficacy and PK characteristics of Rocbrutinib (LP-168) combined with R-GemOx in patients with R\u002FR non-GCB DLBCL. Study includes dose escalation part and dose expansion part. In the dose escalation part, a classic \"3+3\" design will be used to assess the safety of each specified dose combination. Upon completion of a predefined escalation part, the decision on whether to proceed to the dose expansion part will be based on the safety, PK, and efficacy data of the combination regimen.",[28],[136,28,137],"BTK inhibitor","R-GemOx","2026-04-29",{"date":140,"type":39},"2026-05-06",{"date":142,"type":20},"2026-05-30",{"date":144,"type":20},"2028-07-31",{"name":146,"class":70},"Guangzhou Lupeng Pharmaceutical Company LTD.",2,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100557911","phase-1-synkir-310-for-relapsedrefractory-b-nhl-100557911","NCT06544265","SynKIR-310 for Relapsed\u002FRefractory B-NHL","A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Adult 18 years of age and older.\n* Histologically confirmed diagnosis of B-NHL before enrollment.\n* Must have received prior CAR T or were unwilling\u002Funable to receive prior CAR T.\n* Must have refractory or relapsed disease after receiving 2 prior lines of therapies.\n* If relapsed\u002Frefractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.\n* If relapsed\u002Frefractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial\n* Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nExclusion Criteria:\n\n* Previously treated with any investigational agent within 30 days prior to screening.\n* Any previous or concurrent malignancy, with the following exceptions:\n\nAdequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level \\\u003C 1.0 may also be permitted.\n\n* Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis\n* Known immunodeficiency disease , with the exception of hypoglobulinemia\n* History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia\u002Fhemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.\n* Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.\n* Any active uncontrolled systemic fungal, bacterial or viral infection.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":156,"type":20},36,[82],"This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed\u002Frefractory B-NHL.",[160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,28,183,184],"B Cell Lymphoma","NHL, Adult","Mantle Cell Lymphoma","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Aggressive B-Cell Non-Hodgkin Lymphoma","Indolent B-Cell Non-Hodgkin Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","DLBCL - Diffuse Large B Cell Lymphoma","HGBL With MYC and BCL2 and\u002For BCL6 Rearrangements","High-grade B-cell Lymphoma","Diffuse Large B Cell Lymphoma","Large B-cell Lymphoma","T-Cell\u002FHistiocyte Rich Lymphoma","Non-hodgkin Lymphoma,B Cell","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Epstein-Barr Virus Positive DLBCL, Nos","Follicular Lymphoma Grade 3B","DLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic Inflammation","High Grade B-Cell Lymphoma, Not Otherwise Specified","Follicular Lymphoma Grade 3","Marginal Zone Splenic Lymphoma","Waldenstrom Macroglobulinemia","Waldenstrom Macroglobulinaemia","2026-04-08",{"date":187,"type":39},"2026-04-14",{"date":189,"type":39},"2024-11-01",{"date":191,"type":20},"2028-12",{"name":193,"class":70},"Verismo Therapeutics",5,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":4},"100631303","gut-microbiome-in-dlbcl-treated-with-glofitamab-100631303","NCT07498920","Gut Microbiome in DLBCL Treated With Glofitamab","Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With Glofitamab","Inclusion Criteria:\n\n1. Histologically\u002Fcytologically confirmed diagnosis of DLBCL\n2. Is being planned to received Glofitamab\n3. Be able to provide written informed consent\n\nExclusion Criteria:\n\n1. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.\n2. Concurrent second malignancy.",{"count":203,"type":20},30,"OBSERVATIONAL","The gut microbiome (GM) has recently emerged as one of the key modifiable factors of response and prognosis to immunotherapy in cancer patients. Currently, it is unknown if GM also modulates anti-tumor responses to T cell engagers (TCE) including glofitamab in DLBCL patients.",[28,207,208],"Glofitamab","Gut Biome","2026-03-23",{"date":211,"type":39},"2026-03-27",{"date":213,"type":20},"2026-04-01",{"date":215,"type":20},"2029-12-31",{"name":217,"class":95},"Peking Union Medical College Hospital",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":21,"phases":226,"briefSummary":228,"conditions":229,"keywords":240,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},"100401858","early-phase-1-iomab-act-a-pilot-study-of-131-i-apamistamab-followed-by-cd19-targeted-car-t-cell-therapy-for-patients-with-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia-or-diffuse-large-b-cell-lymphoma-100401858","NCT04512716","Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma","Patients with B-ALL or DLBCL (or subtypes thereof) who have relapsed or refractory disease will be eligible. Refractory disease is defined by failure to achieve at least a partial response or disease progression within 6 months of the last therapy. Patients who initially respond but subsequently demonstrate disease progression are considered to have relapsed disease\n\nParticipant Inclusion Criteria:\n\n\\- To be eligible for leukapheresis, patients must have a CD19+ B-cell malignancy with relapsed or refractory disease, defined below. To be eligible for 131-I apamistamab conditioning and treatment with 19-28z CAR T-cells, patients must additionally have detectable evidence of residual malignancy at the time of assessment prior to CAR T-cell infusion (as defined below), regardless of therapy administered following leukapheresis.\n\na. Patients with diffuse large B-cell lymphoma (de novo or DLBCL transformed from an indolent lymphoma (follicular lymphoma, chronic lymphocytic leukemia \\[Richter syndrome\\]) or high-grade B-cell lymphoma (HGBL): (\"DLBCL patients\") i. Defined as relapsed or refractory DLBCL or high-grade B-cell lymphoma (HGBL) following 2 or more prior chemoimmunotherapy regimens (with at least one course including an anthracycline and CD20-directed therapy) following diagnosis of de novo DLBCL\u002FHGBL or DLBCL arising from indolent lymphoma, and requiring further treatment. Exception: patients with Richter syndrome (DLBCL arising from CLL\u002Fsmall lymphocytic lymphoma) are eligible following 1 or more prior chemoimmunotherapy regimens (with at least one course including an anthracycline and CD20-directed therapy) and do not require a second course of chemoimmunotherapy to be eligible.\n\nii. Patients must have at least one FDG-avid (PET-avid) measurable lesion iii. Biopsy confirmation of relapsed of refractory DLBCL is required iv. For patients who have received treatment for confirmed relapsed or refractory disease otherwise meeting criteria a.i.-a.iii. as above, within 6 weeks of study enrollment, active disease does not need to be re-confirmed or present immediately prior to Screening A for the patient to be eligible for leukapheresis. However, detectable evidence of residual malignancy must be present at Screening B in order for the patient to be eligible for 131-I apamistamab and CAR T-cell therapy.\n\nb. Patients with B-cell acute lymphoblastic leukemia or B lymphoblastic lymphoma (ALL) or chronic myeloid leukemia (CML) in lymphoid blast crisis: (\"B-ALL patients\") i. Patients with Philadelphia chromosome-negative B-cell ALL must have been refractory to at least 1 line of multi-agent chemotherapy or relapsed following at least 1 prior multiagent systemic chemotherapy regimen that included induction and consolidation therapy ii. Patients with Philadelphia chromosome-positive ALL or CML in lymphoid blast crisis must have exhibited persistent disease following therapy with a second- or third-generation tyrosine kinase inhibitor iii. Patients must have ≥5% bone marrow involvement and\u002For at least one FDG-avid (PET-avid) measurable extramedullary lesion iv. For patients who have received treatment for confirmed relapsed or refractory disease otherwise meeting criteria b.i.-b.iii. as above, within 6 weeks of study enrollment, active disease does not need to be re-confirmed or present immediately prior to Screening A for the patient to be eligible for leukapheresis. However, detectable evidence of residual malignancy must be present at Screening B in order for the patient to be eligible for 131-I apamistamab and CAR T-cell therapy.\n\n* While prior CD19-targeted therapies, including CAR T-cell therapy, do not exclude participation, CD19 expression by immunohistochemical staining or flow cytometry must be confirmed prior to enrollment.\n* Age ≥ 18 years of age\n* Creatinine clearance ≥50 mL\u002Fmin as calculated by the Cockroft-Gault formula\n* Direct bilirubin ≤2.0 mg\u002FdL, AST and ALT ≤3.0x upper limit of normal (ULN), unless liver dysfunction is thought to be related to underlying malignancy\n* Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.\n* Adequate bone marrow function meeting the following criteria as defined below, without requiring blood product or granulocyte-colony stimulating factor support in the past 7 days, unless cytopenias are attributed to underlying malignancy in the opinion of the investigator:\n\n  1. Absolute neutrophil count ≥0.5k\u002FµL,\n  2. Platelets ≥30k\u002FµL,\n  3. Hemoglobin ≥7g\u002FdL.\n* ECOG performance status 0-2.\n\nParticipant Exclusion Criteria:\n\n* ECOG performance status ≥3.\n* Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.\n* Impaired cardiac function (LVEF \\\u003C40%) as assessed by echocardiogram or MUGA scan during screening\n* Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T-cell suppressive therapy are ineligible\n* Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible\n* Patients with following cardiac conditions will be excluded:\n\n  1. New York Heart Association (NYHA) stage III or IV congestive heart failure\n  2. Myocardial infarction ≤6 months prior to enrollment\n  3. Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n  4. Any history of severe non-ischemic cardiomyopathy with LVEF ≤20%\n* Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions:\n\n  1. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded.\n  2. Subjects who have antibodies to HCV or who have hepatitis B core antibody, with undetectable viremia by PCR, and with adequate organ function as defined in the protocol, are not excluded.\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible.\n* Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.\n* Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.\n* Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.\n* Patients with circulating human anti-mouse antibodies to BC8 noted on initial screening (see Appendix III)\n\nSubject Inclusion Criteria for 131-I Apamistamab Infusion Patients should meet performance status and organ function parameters as specified, without known development of an exclusion criterion, prior to proceeding to 131-I apamistamab infusion. See Section 9.2 re: screening for treatment.",{"count":225,"type":20},12,[227],"EARLY_PHASE1","This is a pilot study; patients will receive 131-I apamistamab prior to CAR T-cell infusion in order to determine the maximum tolerated dose of 131-I apamistamab is exceeded at 75 mCi, and if so, to assess the safety of a step-down dose of 50 mCi.",[230,28,231,232,233,234,235,236,237,238,239],"B-ALL","B ALL","Dlbcl-Ci","DLBCL Unclassifiable","DLBCL, Nos Genetic Subtypes","DLBCL Activated B-Cell Type","DLBCL Germinal Center B-Cell Type","Diffuse Large B-cell Lymphoma","HGBL","HGBL, Nos",[241,242,243,244],"CD19+ B-cell malignancy","131-I apamistamab","B-cell malignancy","Memorial Sloan Kettering Cancer Center","2026-02-13",{"date":247,"type":39},"2026-02-17",{"date":249,"type":39},"2021-02-02",{"date":251,"type":20},"2027-01",{"name":244,"class":95},7,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":285,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":156},"100481055","phase-1-study-of-sgr-1505-in-mature-b-cell-neoplasms-100481055","NCT05544019","Study of SGR-1505 in Mature B-Cell Neoplasms","A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies","Inclusion Criteria:\n\n* Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.\n* Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n* The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).\n* Subject has previous invasive malignancy in the last 2 years.\n* Subject has a known allergy to SGR-1505 or excipients of SGR-1505.\n* Subject has symptomatic or active CNS involvement of disease.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.",{"count":262,"type":20},98,[82],"The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and\u002For recommended dose (RD) of SGR-1505.",[266,267,28,183,268,167,269,270,271,272,273,171,274,275,162,236,276,174,277,278,279,280,281,282,283,284],"Mature B-Cell Neoplasm","Non Hodgkin Lymphoma","MALT Lymphoma","Pediatric-Type Follicular Lymphoma","IRF4 Gene Rearrangement","EBV-Positive DLBCL, Nos","Burkitt Lymphoma","Plasmablastic Lymphoma","Primary Cutaneous Follicle Center Lymphoma","Primary Effusion Lymphoma","Primary Mediastinal Large B Cell Lymphoma","ALK-Positive Large B-Cell Lymphoma","Primary Cutaneous Diffuse Large B-Cell Lymphoma","Splenic Marginal Zone Lymphoma","Chronic Lymphocytic Leukemia","Nodal Marginal Zone Lymphoma","HHV8-Positive DLBCL, Nos","Lymphoplasmacytic Lymphoma","Duodenal-Type Follicular Lymphoma",[286,287,183],"MALT1","NF-kB","2026-02-11",{"date":245,"type":39},{"date":291,"type":39},"2023-04-10",{"date":293,"type":20},"2027-11",{"name":295,"class":70},"Schrödinger, Inc.",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":21,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":47},"100344002","phase-2-a-study-of-pet-adapted-therapy-and-non-invasive-monitoring-for-previously-untreated-limited-stage-diffuse-large-b-cell-lymphoma-100344002","NCT03758989","A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma","A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma","Inclusion Criteria:\n\n* Previously untreated limited stage non bulky DLBCL; defined as limited stage by routine staging criteria in lymphoma involving FDG-PET and bone marrow biopsies (the Lugano criteria)\\[21\\]\n* Patients with grade 3B follicular lymphoma and transformed indolent lymphoma are included\n* Ages ≥ 18\n* Measurable disease, assessable by radiographic examination with FDG-PET showing involvement\n* Access to archived or fresh\u002Ffrozen tumor biopsies\n* No uncontrolled medical comorbidities\n* Adequate cardiac function (EF \\> or equal to 50%), no unstable angina\n* Adequate renal function (GFR \\> 60)\n* Adequate liver function (liver function tests should be no greater than 2 x upper limit of normal) including normal bilirubin levels, no greater than 2 x upper limit of normal unless patient has a history of Gilbert's disease\n* Adequate marrow reserves as indicated by complete blood count in the judgment of the treating investigator\n\nExclusion Criteria:\n\n* Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding\n* Bulky disease greater than 10 cm in any dimension",{"count":304,"type":20},40,[23],"The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.",[28],"2026-02-04",{"date":310,"type":39},"2026-02-09",{"date":312,"type":39},"2019-05-08",{"date":314,"type":20},"2027-06-01",{"name":316,"class":95},"University of Rochester",{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":325,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":47},"100618707","a-real-world-data-and-sample-compendium-of-frail-andor-multiply-treated-large-b-cell-lymphoma-100618707","NCT07335120","A Real-world Data and Sample Compendium of Frail and\u002For Multiply Treated Large B-cell Lymphoma","A reaL-world Data and Sample coMpendium of frAil aNd\u002For Multiply treAted Patients With Large B-Cell Lymphoma","ALMANAC","Inclusion Criteria:\n\n* Males and female subjects ≥16 years of age at the time of enrolment.\n* Ability to understand and sign written informed consent.\n* Previously untreated histologically proven Large B-cell non-Hodgkin's lymphoma (LBCL) according to the current World Health Organisation 2016 classification including all morphological variants.\n\nCohort A:\n\n* Large B-cell lymphomas i) Diffuse large B-cell lymphoma, NOS ii) T-cell\u002Fhistiocyte-rich large B-cell lymphoma iii) Diffuse large B-cell lymphoma\u002F high grade B-cell lymphoma with MYC and BCL2 re-arrangements. iv) High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements v) ALK-positive large B-cell lymphoma vi) Large B-cell lymphoma with IRF4 rearrangement vii) High-grade B-cell lymphoma with 11q aberrations or Burkitt-like lymphoma with 11q aberration viii) EBV-positive diffuse large B-cell lymphoma EBV-positive diffuse large B-cell lymphoma, NOS ix) Diffuse large B-cell lymphoma associated with chronic inflammation x) Fibrin-associated large B-cell lymphoma xi) Plasmablastic lymphoma xii) Primary large B-cell lymphoma of immune-privileged sites (vitro-retinal and testis but not CNS) and Intravascular large B-cell lymphoma xiii) Primary mediastinal large B-cell lymphoma xiv) Mediastinal grey zone lymphoma B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classic Hodgkin lymphoma xv) High-grade B-cell lymphoma, NOS xvi) HIV or KSHV\u002FHHV8-positive diffuse large B-cell lymphoma\n* De novo presentations of transformed indolent B-cell lymphomas.\n* LBCL patients with de novo disease unfit for full dose R-CHOP\u002FPola-R-CHP OR\n\nCohort B:\n\n* LBCL patients (as in Cohort A) with relapsed\u002Frefractory disease (including de novo transformed indolent B-cell lymphomas) following frontline (one previous line of chemo-immunotherapy) including any line CAR-T therapy.\n* Patients fulfilling the above criteria who are on other trials\u002Fstudies are eligible for recruitment.\n* Patients previously registered into Cohort A with subsequent relapsed\u002Frefractory disease. Such patients can be registered into cohort B and will be given a new study number that is linked to their study number for cohort A.\n* Data for patients commencing treatment \\\u003C6 months prior to enrolment and with ongoing follow-up can be entered retrospectively.\n\nExclusion Criteria:\n\n1. Patients treated \\>6 months prior to trial enrolment (Cohort B).\n2. Patients eligible for full dose R-CHOP\u002FPola-R-CHP (Cohort A)\n3. Patients with CNS lymphoma\n4. Lymphoid proliferations and lymphomas associated with immune suppression and dysregulation. (e.g., Post-Transplant Lymphoproliferative Disorders)","17 Years",{"count":327,"type":20},800,"LBCL is a cancer of the lymphatic system where B-cells (a type of white blood cell) experience uncontrolled growth. The standard treatment for LBCL is a combination of chemotherapy and immunotherapy, referred to as chemo-immunotherapy. Currently, the best results in the treatment of LBCL is with a chemo-immunotherapy combination called R-CHOP or Pola-R-CHP. Full doses of treatment are not suitable for elderly or frail patients due to potential to cause side effects and heart problems. Such patients either receive a reduced dose called mini-R-CHOP or receive alternatives (e.g. R-GCVP or R-CEOP). Additionally, some patients treated with R-CHOP or Pola-R-CHP may not respond or may respond initially before relapsing. For these patients, treatment is not standardised, and practice varies between hospitals. ALMANAC aims to collect data about the management and outcomes of patients with LBCL who are unsuitable for standard treatments because they are not well enough to tolerate the side effects or because they have not responded or relapsed following initial treatment. In doing so, it will guide research into LBCL leading to a better understanding of this condition and better outcomes.",[28],"2026-01-05",{"date":332,"type":39},"2026-01-12",{"date":334,"type":39},"2024-10-30",{"date":336,"type":20},"2028-10-30",{"name":338,"class":95},"The Clatterbridge Cancer Centre NHS Foundation Trust",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":47},"100605399","early-phase-1-safety-and-efficacy-of-anti-ebv-autologous-tcr-t-cell-injection-in-relapsedrefractory-ebv-positive-lymphoma-100605399","NCT07162012","Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed\u002FRefractory EBV-Positive Lymphoma","The Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection for Treating Relapsed\u002FRefractory EBV-positive Lymphoma Patients With HLA-A11:01","Anti-EBV TCR-T","Inclusion Criteria:\n\n1. Age 18-70 years, male or female.\n2. HLA genotype at locus A is 11:01.\n3. Disease diagnosis and status:\n\n   1. Histologically or cytologically confirmed EBV-positive lymphoma (tumor tissue must be EBER-positive as confirmed by in situ hybridization \\[ISH\\] or fluorescence in situ hybridization \\[FISH\\]), with peripheral blood EBV viral load \\>10³ copies\u002FmL by quantitative real-time PCR.\n   2. Disease types include but are not limited to:\n\n      NK\u002FT-cell lymphoma (NK\u002FTCL); Peripheral T-cell lymphoma (PTCL); Other types.\n   3. Definition of relapse: appearance of new lesions at the primary site or other sites after achieving complete remission (CR).\n   4. Definition of refractory disease (meeting any of the following):\n\n   No partial remission (PR) after ≥4 cycles of standard therapy; No complete remission (CR) after ≥6 cycles of therapy; Failure to achieve CR after autologous hematopoietic stem cell transplantation; If best response is progressive disease (PD) or treatment is discontinued due to PD, no minimum cycle requirement applies.\n4. Prior treatment requirements:\n\n   a) For relapsed\u002Frefractory PTCL or NK\u002FTCL, patients must have received at least one prior line of systemic therapy. For relapsed\u002Frefractory NK\u002FTCL, patients must have received an asparaginase-containing regimen (patients with stage I\u002FII nasal NK\u002FTCL according to the CA staging system must have also received radiotherapy).\n5. Measurable disease: At least one measurable lesion according to the 2014 Lymphoma Response Evaluation Criteria:\n\n   1. Nodal lesions: longest diameter \\>15 mm on contrast-enhanced CT, MRI, or PET-CT;\n   2. Extranodal lesions: longest diameter \\>10 mm. For patients with bone-marrow-only involvement who have no measurable lesions on imaging, the presence of ≥5% lymphoma cells in bone marrow biopsy or flow cytometry can be considered an evaluable lesion.\n6. Adequate organ function, defined as:\n\n   1. Hematologic: absolute neutrophil count ≥1×10⁹\u002FL; hemoglobin ≥70 g\u002FL; platelet count ≥50×10⁹\u002FL;\n   2. Hepatic: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × the upper limit of normal (ULN), and total bilirubin (TBIL) ≤ 1.5 × ULN (except when liver function abnormalities are attributable to the underlying disease);\n   3. Renal: serum creatinine ≤1.5× ULN;\n   4. Cardiac: left ventricular ejection fraction (LVEF) ≥50%;\n   5. Coagulation: fibrinogen ≥1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤1.5× ULN; prothrombin time (PT) ≤1.5× ULN.\n7. Expected survival \\>3 months.\n8. ECOG performance status \\\u003C3.\n9. Contraception requirements:\n\n   1. No pregnancy planned during the treatment period;\n   2. Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 4 months after the end of treatment.\n10. Willingness to participate in the study, ability to sign informed consent, comply with the study protocol, and availability of peripheral venous access for lymphocyte collection.\n\nExclusion Criteria:\n\nSubjects meeting any of the following conditions will not be eligible for enrollment:\n\n1. History of other malignancies, except for:\n\n   1. Basal cell carcinoma of the skin;\n   2. Squamous cell carcinoma of the skin;\n   3. Superficial bladder cancer;\n   4. Carcinoma in situ of the cervix;\n   5. Gastrointestinal mucosal carcinoma in situ;\n   6. Other malignancies considered acceptable by the investigator (must have received curative treatment with no recurrence within the past 5 years).\n2. Recent anti-tumor therapy: less than 4 weeks since last anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local therapy), or less than 2 weeks since palliative radiotherapy.\n3. Pregnant or breastfeeding women.\n4. Presence of severe medical conditions such as intracranial hypertension, impaired consciousness, respiratory failure, or disseminated intravascular coagulation (DIC).\n5. Severe organ dysfunction, including:\n\n   NYHA class IV cardiac function; Child-Pugh class C liver function; Creatinine clearance \\\u003C60 mL\u002Fmin (by Cockcroft-Gault formula); Baseline oxygen saturation \\\u003C92%.\n6. Known active infections or positive screening results for:\n\n   1. Hepatitis B virus (HBV): HBsAg positive, or HBcAb positive with HBV-DNA above the detection limit of the study center;\n   2. Hepatitis C virus (HCV): HCV antibody positive and HCV RNA ≥ upper limit of normal (ULN);\n   3. Human immunodeficiency virus (HIV) or Treponema pallidum (syphilis) antibody positive;\n   4. Active tuberculosis (TB) (must be excluded by chest X-ray, sputum test, and clinical symptoms) or history of active TB;\n   5. Severe acute or chronic infections requiring systemic treatment.\n7. Active central nervous system (CNS) disease (e.g., tumor metastasis, infection, demyelinating disease), including untreated lesions, progressive disease on imaging or symptoms requiring urgent intervention, or requiring high-dose immunosuppressive therapy for control.\n8. Receiving systemic corticosteroid therapy prior to screening and judged by the investigator to require long-term systemic corticosteroid treatment during the study (excluding inhaled or topical use); or receiving systemic corticosteroid treatment within 72 hours before cell infusion (excluding inhaled or topical use).\n9. Presence of graft-versus-host disease (GVHD), defined as grade ≥2 acute GVHD or moderate\u002Fsevere chronic GVHD, or current use of immunosuppressive therapy.\n10. History of severe allergic reactions to drugs or excipients required in this study, or history of allergy to tocilizumab.\n11. Any condition that, in the opinion of the investigator, makes the subject unsuitable for study participation.","70 Years",{"count":349,"type":20},24,[227],"This study will test whether anti-EBV autologous TCR-T cell injection is safe and effective for patients with relapsed or refractory EBV-positive lymphoma who have HLA-A11:01. Researchers will look at safety, tolerability, and the maximum tolerated dose or recommended dose for future studies.\n\nThe study will also measure how the infused TCR-T cells expand and persist in the body, changes in EBV DNA levels and T-cell subgroups in the blood, and whether the treatment shows early signs of clinical benefit. Researchers will also explore whether the treatment causes an immune response against the infused cells.",[353,354,28],"NK\u002FT-cell Lymphoma","Peripheral T-cell Lymphoma (PTCL)",{"date":356,"type":39},"2025-12-02",{"date":358,"type":39},"2025-09-20",{"date":360,"type":20},"2029-09",{"name":362,"class":95},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":372,"conditions":373,"keywords":374,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":47},"100598373","study-on-predicting-response-to-standard-first-line-treatment-in-diffuse-large-b-cell-lymphoma-dlbcl-patients-using-ctdna-combined-with-pet-100598373","NCT07070648","Study on Predicting Response to Standard First-Line Treatment in Diffuse Large B-Cell Lymphoma (DLBCL) Patients Using ctDNA Combined With PET","Study on Predicting Response to Standard First-Line Treatment in Diffuse Large B-Cell Lymphoma (DLBCL) Patients Using ctDNA Combined With PET: A Prospective, Multicenter, Multicohort Investigation","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Previously untreated CD20-positive DLBCL patients, including the following types according to the 2016 WHO classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS) including germinal center B-cell type and activated B-cell type; T-cell\u002Fhistiocyte-rich large B-cell lymphoma; Epstein - Barr virus-positive DLBCL, NOS; ALK-positive large B-cell lymphoma; HHV8-positive DLBCL, NOS; high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements (double-hit or triple-hit lymphoma); high-grade B-cell lymphoma, NOS.\n* Signed informed consent form (ICF).\n* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2, with an expected survival greater than 12 months.\n* Have at least one measurable two-dimensional lesion determined by clinical examination, CT scan, or MRI: ① lymph nodes \\> 1.5 cm; ② other non-lymph node lesions ≥ 1.0 cm.\n* Good function of major organs: Hematological function: absolute neutrophil count ≥ 1,000\u002Fmm³, platelet count ≥ 75,000\u002Fmm³; Liver function: ALT\u002FAST \\\u003C 3 times the upper limit of normal (ULN) and total bilirubin ≤ 1.5× ULN (for patients with Gilbert syndrome, hilar compressive adenopathy-induced cholestasis, liver involvement or lymphoma-induced biliary obstruction \\\u003C 5 times ULN); Renal function: creatinine clearance \\> 30 mL\u002Fmin, creatinine ≤ 1.5× ULN; Pulmonary function: indoor oxygen saturation ≥ 95%; Cardiac function: no obvious cardiac insufficiency or cardiovascular disease.\n* Fertile patients must be willing to take highly effective contraceptive measures during the study and within 120 days after the last administration of treatment.\n\nExclusion Criteria:\n\n* Patients planned to receive short-cycle chemotherapy and radiotherapy.\n* Subjects judged by the investigator to have any factors affecting compliance with the protocol, including uncontrollable medical, psychological, family, sociological or geographical conditions; or unwilling or unable to comply with the procedures required in the study protocol.\n* Known human immunodeficiency virus (HIV) infection or positive immunassay.\n* Viral infections that cannot be controlled by antiviral drugs, such as herpesvirus active infection, acute or chronic active hepatitis B, acute or chronic active hepatitis C, etc. (Note: Chronic HBV carriers or inactive HBsAg-positive subjects with HBV-DNA below the detection limit can be enrolled, requiring clinical evaluation, and if appropriate, preventive antiviral treatment is required; HCV antibody-negative subjects can be enrolled, and HCV antibody-positive patients need to be tested for HCV-RNA, and if negative, they can be enrolled).\n* Patients with uncontrolled lymphoma central nervous system infiltration (central nervous system diseases diagnosed at the initial diagnosis are allowed, provided that complete remission of central nervous system diseases is achieved and maintained and there is no central nervous system disease at recurrence).\n* Pregnant or lactating patients.\n* Other concurrent serious diseases or medical conditions that would interfere with participation in the study.",{"count":371,"type":20},300,"This is a prospective, multicenter, multi-cohort study of ctDNA combined with PET for predicting the efficacy of standard first-line therapy for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).",[27,28],[27,375,376],"ctDNA","PET-CT","2025-07-08",{"date":379,"type":39},"2025-07-17",{"date":381,"type":39},"2025-05-09",{"date":383,"type":20},"2027-12-30",{"name":385,"class":95},"Fudan University",{"id":387,"slug":388,"hasResults":11,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":16,"minAge":347,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":21,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":47},"100574342","phase-2-clinical-study-of-hirx-therapy-for-newly-diagnosed-elderly-patients-with-dlbcl-intolerant-to-chemotherapy-100574342","NCT06758037","Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy","A Single-arm, Multicenter Phase II Clinical Study of HiR+X Therapy for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy, Guided by Molecular Subtyping and Clinical Characteristics.","HiR+X","Inclusion Criteria:\n\n1. Age ≥ 70 years;\n2. ECOG score 0-3;\n3. Rated as \"unfit\" or \"frail\" on the simplified geriatric assessment (sGA);\n4. Histologically confirmed CD20-positive diffuse large B-cell lymphoma \\[diagnostic criteria according to WHO 2016\\], excluding transformed type 2 DLBCL;\n5. Previously untreated, newly diagnosed patients;\n6. Cardiac, hepatic, and renal function: creatinine \\\u003C 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase) \u002F AST (aspartate aminotransferase) \\\u003C 2.5 x ULN; total bilirubin \\\u003C 2 x ULN;\n7. At least one measurable lesion;\n8. Intolerance to standard CHOP chemotherapy regimen or unwillingness to receive chemotherapy;\n9. Sufficient understanding and voluntary signing of the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with central nervous system involvement at the onset of the disease;\n2. Known human immunodeficiency virus (HIV) infection;\n3. Pregnant or lactating women;\n4. Other tumors requiring treatment;\n5. Uncontrolled active infection;\n6. Active hepatitis with HBV-DNA copy number unable to be controlled within 2000\u002FmL despite antiviral treatment;\n7. Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.","100 Years",{"count":396,"type":20},50,[23],"To explore the application of HiR (Zebtorizumab, Lenalidomide) + X (targeted drug) guided by NGS molecular typing, the aim is to assess the therapeutic efficacy and safety in newly diagnosed unfit or frail elderly patients with DLBCL aged ≥70 years, and to investigate the genetic subtypes that may benefit from HiR-X.",[28,27],[28,401,402,403,404],"genetic subtypes","Zebtorizumab","Lenalidomide","unfit","2025-03-16",{"date":407,"type":39},"2025-03-18",{"date":409,"type":39},"2025-01-15",{"date":411,"type":20},"2027-06-30",{"name":413,"class":414},"First Affiliated Hospital of Ningbo University","NETWORK",{"id":416,"slug":417,"hasResults":11,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":21,"phases":424,"briefSummary":425,"conditions":426,"keywords":428,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":194},"100476686","phase-1-a-study-of-rnk05047-in-subjects-with-advanced-solid-tumorsdiffuse-large-b-cell-lymphoma-champ-1-100476686","NCT05487170","A Study of RNK05047 in Subjects With Advanced Solid Tumors\u002FDiffuse Large B-cell Lymphoma (CHAMP-1)","A Phase 1\u002F2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1)","Inclusion Criteria:\n\n* Pathologically documented locally advanced or metastatic solid tumor\n* Refractory or intolerant to all available standard-of-care therapies for advanced disease\n* Measurable disease\n* Archived tumor tissue collected\n* ECOG Performance Status of 0 or 1\n* BMI ≥ 18 kg\u002Fm2\n* Adequate liver, renal, hematologic, and coagulation parameters\n* Negative serum pregnancy test (for women of childbearing potential) at Screening and a negative urine or serum pregnancy test on Day 1 prior to the first infusion\n* Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 4 months after the last dose of study treatment.\n* Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.\n\nExclusion Criteria:\n\n* Concurrent anticancer therapy: Radiotherapy, chemotherapy, biological therapy, or other anticancer investigational agents NOTE: at least 5 half-lives must have been ensued for any prior systemic cancer therapy agent before subject received the study drug on Day 1\n* Unresolved toxicities from prior anticancer therapy, defined as not having resolved according to CTCAE version 5.0 Grade ≤ 1, excluding Grade 1 alopecia\n* Presence or suspicion of active central nervous system (CNS) metastases and\u002For leptomeningeal carcinomatosis\n* Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0\n* Known active infection with HIV, HTLV-1, hepatitis B or C\n* Women who are pregnant or breastfeeding\n* History of another malignancy unless the subject has been treated with curative intent for this malignancy",{"count":423,"type":20},32,[82,23],"This is a first in human, Phase 1\u002F2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability, PK, PD and efficacy of RNK05047 when administered an intravenous (IV) infusion to subjects with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL).\n\nThis is a 2-part study (dose escalation, cohort expansion) with sequential enrollment.",[427,28],"Advanced Solid Tumor",[429],"protein degrader","2025-02-27",{"date":432,"type":39},"2025-03-04",{"date":434,"type":39},"2022-07-12",{"date":436,"type":20},"2025-09-01",{"name":438,"class":70},"Ranok Therapeutics (Hangzhou) Co., Ltd.",{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":448,"conditions":449,"keywords":450,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":47},"100575988","a-multicenter-prospective-real-world-study-of-a-regimen-containing-tucidinostat-for-primary-treatment-of-dlbcl-100575988","NCT06779435","A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL","A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* 1\\. Age ≥18 years old, male or female;\n* 2\\. No previous treatment for DLBCL, including chemotherapy, targeted therapy and immunotherapy;\n* 3\\. DEL \\[Diffuse large B-cell lymphoma with double expression of MYC and BCL2 (immunohistochemical MYC≥40%, BCL2≥50%)\\] was confirmed by pathology; Or non-double expression but at least one of the following:;\n\n  1. TP53 or other epigenetic gene mutations (as in: ACTB, BCL6, BCOR, CREBBP, EP300, EZH2, HIST1H1C, HIST1H1E, HIST1H2BK, HIST2H2AB, IRF4, KMT2A, KMT2C, KMT2D, MYC, MYD88, NSD2, RAG1, SETD1B SF3B1, SIN3A, TBL1XR1, TET2, TOX, TP53, TRIP12, TRRAP, UBE2A)\n  2. MYC and BCL2 double hit\n* 4\\. Plan to receive or are receiving a treatment regimen containing tucidinostat (if it is permitted to start using tucidinostat after obtaining specific test results due to pending genetic sequencing results);\n* 5\\. Voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* 1\\. Patients currently enrolled or planning to participate in any interventional clinical trial;\n* 2\\. The expected survival time is less than 6 months;\n* 3\\. There are any other reasons that the investigators believe are not suitable for patients to participate in this study.",{"count":447,"type":20},400,"This is a prospective, observational, multicenter, cohort study with 400 newly treated DLBCL patients. To evaluate the clinical efficacy and safety of tucidinostat in the real-world treatment of primary diffuse large B-cell lymphoma",[28],[451,28],"Tucidinostat","2025-02-17",{"date":454,"type":39},"2025-02-19",{"date":456,"type":39},"2025-01-01",{"date":458,"type":20},"2028-06-30",{"name":460,"class":95},"Ruijin Hospital",{"id":462,"slug":463,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":468,"targetDuration":4,"studyType":21,"phases":470,"briefSummary":471,"conditions":472,"keywords":473,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":47},"100569985","phase-2-cr-chopx-in-previously-untreated-del-100569985","NCT06701357","CR-CHOP+X in Previously Untreated DEL","A Prospective, Open-label Phase II Study of Chidamide Plus R-CHOP + X in Previously Untreated Diffuse Large B-cell Lymphoma with Double Expression of MYC and BCL2.","Inclusion Criteria:\n\n* 1\\. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive;\n* 2\\. MYC and BCL2 are expressed simultaneously, WHO immunohistochemical standards: MYC≥40%, BCL2 ≥50%;\n* 3\\. Age ≥ 18 years old, ≦75 years old;\n* 4\\. ECOG physical status score of 0, 1 or 2;\n* 5\\. No previous history of malignant tumors; No other tumors occurred simultaneously;\n* 6\\. Patients judged by the investigator to have a life expectancy of at least 6 months;\n* 7\\. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure;\n* 8\\. International prognostic Index (IPI) \\>1 score.\n\nExclusion Criteria:\n\n* 1\\. Have previously received systemic or local treatment including chemotherapy;\n* 2\\. Previously received autologous stem cell transplantation;\n* 3\\. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;\n* 4\\. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases;\n* 5\\. Primary central nervous system lymphoma;\n* 6\\. Left ventricular ejection fraction ≤ 50%;\n* 7\\. Laboratory test values at the time of screening (unless due to lymphoma): A. Neutrophils \\\u003C1.5\\*109\u002FL; B. Platelet \\\u003C75\\*109\u002FL; C. ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal; D. Creatinine levels higher than 1.5 times the upper limit of normal;\n* 8\\. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study;\n* 9\\. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;\n* 10\\. Pregnant or lactating women;\n* 11\\. People living with HIV;\n* 12\\. Patients with positive HbsAg test results need to undergo HBV DNA test, and can be enrolled before turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV DNA test should also be performed. If the result is positive, the treatment should also be negative before admission.",{"count":469,"type":20},49,[23],"This is a prospective, single-arm, open-label phase II clinical trial that evaluates the efficacy and safety of CR-CHOP regimen combined with different targeted drugs based on different molecular subtypes in newly diagnosed DEL patients.",[28],[28,474,475],"double-expression","chidamide","2024-12-26",{"date":478,"type":39},"2024-12-30",{"date":480,"type":39},"2024-12-10",{"date":482,"type":20},"2028-12-01",{"name":460,"class":95},{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":491,"targetDuration":4,"studyType":21,"phases":493,"briefSummary":494,"conditions":495,"keywords":496,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":505,"locationsCount":47},"100573800","phase-2-cd-rchop-in-nd-dlbcl-with-a-combination-of-tp53-mutation-and-del17p-100573800","NCT06750991","CD-RCHOP in ND DLBCL With a Combination of TP53 Mutation and Del(17p)","A Prospective, Open-label Phase II Study of Chidamide, Decitabine Plus R-CHOP in Previously Untreated Diffuse Large B-cell Lymphoma With a Combination of TP53 Mutation and Del(17p)","Inclusion Criteria:\n\n* 1\\. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive;\n* 2\\. Pathologically confirmed a combination of TP53 mutation and del(17p);\n* 3\\. Age ≥ 18 years old, ≦75 years old;\n* 4\\. ECOG physical status score of 0, 1 or 2;\n* 5\\. No previous history of malignant tumors; No other tumors occurred simultaneously;\n* 6\\. Patients judged by the investigator to have a life expectancy of at least 6 months;\n* 7\\. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure.\n* 8\\. International prognostic Index (IPI) \\>1 score.\n\nExclusion Criteria:\n\n* 1\\. Have previously received systemic or local treatment including chemotherapy;\n* 2\\. Previously received autologous stem cell transplantation;\n* 3\\. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;\n* 4\\. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases;\n* 5\\. Primary central nervous system lymphoma;\n* 6\\. Left ventricular ejection fraction ≤ 50%;\n* 7\\. Laboratory test values at the time of screening (unless due to lymphoma); A. Neutrophils \\\u003C1.5\\*109\u002FL; B. Platelet \\\u003C75\\*109\u002FL; C. ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal.\n\nD. Creatinine levels higher than 1.5 times the upper limit of normal\n\n* 8\\. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study.\n* 9\\. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;\n* 10\\. Pregnant or lactating women;\n* 11\\. People living with HIV.\n* 12\\. Patients with positive HbsAg test results need to undergo HBV DNA test, and can be enrolled before turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV DNA test should also be performed. If the result is positive, the treatment should also be negative before admission.",{"count":492,"type":20},34,[23],"This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI\\>1. Participants who met the inclusion\u002Fexclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen.",[28],[28,497,498],"TP53","Chidamide","2024-12-20",{"date":501,"type":39},"2024-12-27",{"date":503,"type":20},"2024-12-31",{"date":482,"type":20},{"name":460,"class":95},{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":513,"enrollmentInfo":514,"targetDuration":4,"studyType":21,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":523,"leadSponsor":525,"locationsCount":4},"100566206","phase-2-zanubrutinib-combined-with-beam-for-asct-in-relapsed-and-refractory-dlbcl-100566206","NCT06652165","Zanubrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL","A Single-center, Randomized Controlled Clinical Study of Zanubrutinib Combined With Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preconditioning Regimen for ASCT in Relapsed and Refractory DLBCL","Inclusion Criteria:\n\n1. According to world Health Organization (WHO) classification of disease, diffuse large B-cell lymphoma was confirmed by histology, CR or PR after second-line and above treatment;\n2. 18≤ age ≤65 years old, male or female;\n3. ECOG score 0-2;\n4. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :\n\n   1. White blood cell count ≥3.0×109\u002FL, absolute neutrophil count ≥1.5×109\u002FL, Hemoglobin ≥90g\u002FL, platelet ≥75×109\u002FL;\n   2. Total bilirubin ≤1.5× upper normal value (ULN);\n   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; Bilirubin ≤1.5× ULN\n   4. Creatinine clearance was 44-133 mmol\u002FL;\n5. No cardiac dysfunction;\n6. Life expectancy over 3 months;\n7. The subject or his\u002Fher legal representative must provide written informed consent prior to conducting a special study examination or procedure.\n\nExclusion Criteria:\n\n1. Previously received autologous hematopoietic stem cell transplantation;\n2. Suffering from serious complications or severe infection;\n3. Previous treatment with selinexor;\n4. Central nervous system lymphoma was excluded;\n5. A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;\n6. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;\n7. HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA\u002FRNA testing must be negative;\n8. Left ventricular ejection fraction ≦ 50%;\n9. Laboratory test value during screening;\n\n   ① Neutrophils \\\u003C1.5×109\u002FL; Platelet \\\u003C75×109\u002FL;\n\n   ② Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit;\n\n   ③ The creatinine level is higher than 1.5 times the upper limit of normal value;\n10. Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;\n11. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;\n12. Pregnant or lactating women;\n13. The researcher judged that the patients were not suitable for this study.","65 Years",{"count":515,"type":20},66,[23],"This trial is a prospective, single-center, randomized controlled clinical research. The intention is to evaluate the efficacy and safety of zanubrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients through prospective clinical studies.",[28],"2024-10-21",{"date":521,"type":39},"2024-10-22",{"date":189,"type":20},{"date":524,"type":20},"2028-11-01",{"name":460,"class":95},{"id":527,"slug":528,"hasResults":11,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":21,"phases":535,"briefSummary":536,"conditions":537,"keywords":538,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":548},"100388057","phase-3-a-randomized-multicenter-phase-iii-trial-comparing-treatment-with-r-mini-chop-with-r-mini-chp--polatuzumab-vedotin-in-patients-with-diffuse-large-cell-b-cell-lymphoma-100388057","NCT04332822","A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma","R-MINI-CHOP Versus R-MINI-CHP in Combination With Polatuzumab-vedotin, as Primary Treatment for Patients With Diffuse Large B-cell Lymphoma, ≥80 Years, or Frail ≥75 Years - an Open Label Randomized Nordic Lymphoma Group Phase III Trial","POLAR BEAR","Inclusion Criteria:\n\n* Age ≥80 years or frail ≥75 years, according to simplified comprehensive geriatric assessment\n* Histologically confirmed lymphoma belonging to one of the following subtypes:\n\n  1. diffuse large B-cell lymphoma, including transformation from an indolent lymphoma\n  2. follicular lymphoma grade 3B\n  3. T-cell\u002Fhistiocyte-rich LBCL\n  4. primary cutaneous DLBCL, leg type\n  5. EBV-positive DLBCL, NOS\n  6. primary mediastinal LBCL\n  7. high grade B-cell lymphoma with MYC\u002FBCL2 rearrangement\n* Stage II-IV disease\n* At least 1 measurable site of disease (\\>1.5 cm long axis)\n* No previous treatment for lymphoma\n* WHO performance status 0 - 3 (Grade 3 if related to DLBCL)\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe cardiac disease: NYHA grade 3-4\n* CNS involvement at diagnosis\n* Uncontrolled serious infection\n* Impaired liver (transaminases \\> 3x normal upper limit or bilirubin \\> 1.5 x normal upper limit, unless due to Gilbert´s syndrome) , renal (GFR\\\u003C30ml\u002Fmin) or other organ function not caused by lymphoma, which will interfere with the treatment.\n* Absolute neutrophil count (ANC) \\\u003C1000 cells\u002FµL or platelets \\\u003C100,000 cells\u002FµL, unless due to lymphoma\n* Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment\n* Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study\n* Known hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, vincristine or doxorubicin, or HACA against rituximab\n* Peripheral neuropathy grade ≥ 2",{"count":371,"type":20},[58],"This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2027.",[28,172],[28,172],"2024-09-10",{"date":541,"type":39},"2024-09-19",{"date":543,"type":39},"2020-08-19",{"date":545,"type":20},"2028-12-28",{"name":547,"class":414},"Nordic Lymphoma Group",69,{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":21,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":47},"100559849","phase-2-a-study-of-trilaciclib-combined-with-chemotherapy-in-the-treatment-of-diffuse-large-b-cell-lymphoma-patients-100559849","NCT06569485","A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients","Phase 2 Study Evaluating Efficacy and Safety of Trilaciclib In Diffuse Large B-Cell Lymphoma Patients Receiving The Standard Chemotherapy R-CHOP.","Inclusion Criteria:\n\n1. Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);\n2. Age above 18 years old (including 18 years old)，regardless of gender;\n3. Treatment-naive, histologically confirmed DLBCL, at least one tumor lesion that could be measured accurately at baseline according to RECIST1.1 criteria;\n4. IPI score 0-2;\n5. ECOG score of 0-2；\n6. No prophylactic G-CSF, TPO, IL-11, ESA, iron within 1 week of screening hematology test, and no platelet transfusion or blood transfusion；\n7. Estimated survival greater than 3 months；\n8. Adequate organ function；\n9. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;\n10. Women of childbearing potential must undergo a serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female patients of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 3 months after the last dose of study drug.\n\nExclusion Criteria:\n\n1. The subject is participating in other interventional clinical studies;\n2. The subject has previous or concurrent other malignancies;\n3. Lymphoma bone marrow invasion;\n4. The presence of symptomatic brain metastases requiring immediate radiotherapy or steroid therapy;\n5. Known hypersensitivity to the applied drugs or any excipients；\n6. Previous hematopoietic stem cell or bone marrow transplantation；\n7. Active infection requiring systemic treatment;\n8. Patients with uncontrolled cardiac clinical symptoms or diseases;\n9. The subject has severe active infection or unexplained fever \\> 38.5 degrees during screening or before the first dose (the subject can be enrolled due to tumor fever as judged by the investigator);\n10. Radiotherapy or radiotherapy at any site within 2 weeks before study medication;\n11. Any investigational drug within 4 weeks before study medication;\n12. Live attenuated vaccine within 4 weeks before study medication or possibly during the study period, influenza vaccine can be administered during the influenza season;\n13. Pregnant or lactating women;\n14. Any reasons that the investigator believes that it should be excluded from this study.",{"count":557,"type":20},38,[23],"This is a prospective, single-arm, multi-center, phase II clinical study to evaluate the efficacy and safety of Trilaciclib in DLBCL patients treated with R-CHOP.",[28],"2024-08-23",{"date":563,"type":39},"2024-08-26",{"date":565,"type":39},"2024-05-23",{"date":567,"type":20},"2027-12-01",{"name":569,"class":95},"Sun Yat-sen University",{"id":571,"slug":572,"hasResults":11,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":21,"phases":579,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":105},"100556143","phase-3-evaluate-the-safety-and-efficacy-of-tafasitamab-and-lenalidomide-in-combination-with-gemcitabine-and-oxaliplatin-versus-rituximab-in-combination-with-gemcitabine-and-oxaliplatin-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100556143","NCT06521255","Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. 18 Years and older.\n2. One of the histologies of DLBCL confirmed by participated sites below with，not otherwise specified;T-cell\u002Fhistiocyte-rich large B-cell lymphoma;Epstein-Barr virus (EBV) positive DLBCL (EBV-positive DLBCL); Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse; Disease transformed from an earlier diagnosis of low-grade lymphoma into DLBCL with DLBCL treatment failure.\n3. Availability of tumor tissue biopsied post last line of therapy and prior to current study treatment for the patients enrolled in safety and tolerability stage.\n4. Relapsed\u002Frefractory (R\u002FR) DLBCL, at least one (≥1) but no more than three (≤3) line of prior systemic therapies.\n5. Patients who have not received high dose therapy\u002Fstem cell transplantation (HDT\u002FSCT) must be ineligible for HDT\u002FSCT.\n6. At least one measurable site of disease per CT or magnetic resonance imaging (the longest axis of the lymph node lesion is \\> 1.5 cm, and the longest diameter of the extra-nodal lesion is \\> 1.0 cm).\n7. ECOG PS score of 0 to 2.\n8. Subject must have adequate organ functions, and the laboratory values comply with the protocol requirements.\n9. Life expectancy of ≥ 3 months.\n10. Informed consent before screening and can understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Existing or prior history of other malignant tumor within 3 years, except for those who have received curative treatment.\n2. Current or history of central nervous system (CNS) lymphoma.\n3. Known high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements.\n4. Primary mediastinal B-cell lymphoma.\n5. History of allogeneic stem-cell transplantation.\n6. Prior exposure to anti-CD19 treatment, and (or) failed with gemcitabine plus platinum-based agent combination therapy.\n7. Current toxicity of ≥ Grade 2 from prior anti-cancer therapy (except for alopecia, neutrophil, hemoglobin and platelets).\n8. Clinically significant cardiovascular disease or nervous system disease.\n9. History of deep venous thrombosis\u002Fembolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing\u002Fable to take venous thromboembolic event prophylaxis during the entire treatment period.\n10. Uncontrolled systemic infection requiring parenteral intravenous anti-infective therapy.\n11. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B or C infection.",{"count":578,"type":20},244,[58],"This is a Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination with Gemcitabine and Oxaliplatin versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed\u002FRefractory Diffuse Large B-Cell Lymphom",[28],"2024-07-24",{"date":584,"type":39},"2024-07-25",{"date":586,"type":39},"2024-05-07",{"date":588,"type":20},"2029-12",{"name":590,"class":70},"Beijing InnoCare Pharma Tech Co., Ltd.",{"id":592,"slug":593,"hasResults":11,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":21,"phases":599,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":47},"100481740","phase-2-evaluate-the-safety-and-efficacy-of-tafasitamab-combined-with-lenalidomide-in-patients-with-relapsed-or-refractory-dlbcl-100481740","NCT05552937","Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory DLBCL","A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Histologically confirmed diagnosis of DLBCL not otherwise specified (NOS); T cell\u002Fhistiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma, Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma\u002FWorld Health Organization (REAL\u002FWHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia) into DLBCL with a subsequent DLBCL relapse are also eligible.\n3. Patients received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy.\n4. Patients must meet the following laboratory criteria at screening.\n5. Patients must use an effective barrier method of contraception.\n6. In the opinion of the investigator the patients must be able and willing to receive adequate prophylaxis and\u002For therapy for thromboembolic events; be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.\n\nExclusion Criteria:\n\n1. Patients who have other histological type of lymphoma，primary refractory DLBCL，a history of \"double\u002Ftriple hit\" genetics.\n2. Patients who have, within 14 days prior to Day 1 dosing:\n\n   1. not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy.\n   2. undergone major surgery or suffered from significant traumatic injury.\n   3. received live vaccines.\n   4. required parenteral antimicrobial therapy for active, intercurrent infections.\n3. Patients who:\n\n   1. were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN).\n   2. have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.\n   3. have undergone previous allogenic stem cell transplantation.\n   4. have a history of deep venous thrombosis\u002Fembolism and who are not willing\u002Fable to take venous thromboembolic event prophylaxis during the entire treatment period.\n   5. concurrently use other anticancer or experimental treatments.\n4. Prior history of malignancies other than DLBCL.\n5. Patients with:\n\n   1. positive hepatitis B and\u002For C serology.\n   2. known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).\n   3. CNS lymphoma involvement.\n   4. history or evidence of clinically significant cardiovascular, CNS and\u002For other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent.\n   5. history or evidence of severe hepatic impairment (total serum bilirubin \\> 3 mg\u002FdL).",{"count":396,"type":20},[23],"This is a A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma",[28],"2022-09-21",{"date":604,"type":39},"2022-09-23",{"date":606,"type":39},"2021-09-06",{"date":608,"type":20},"2027-04",{"name":590,"class":70},{"id":611,"slug":612,"hasResults":11,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":616,"eligibilityCriteria":617,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":21,"phases":620,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":47},"100313100","phase-1-phase-i-ii-study-in-cd30-positive-diffuse-large-b-cell-lymphoma-patients-refractory-to-first-line-chemotherapy-or-in-first-relapse-100313100","NCT03356054","Phase I-II Study in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse","Phase I-II Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (R-DHAP) in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse Who Are Eligible for High Dose Treatment Followed by Autologous Stem Cell Transplantation","HOVON 136 NHL","Inclusion Criteria:\n\n* CD30 positive DLBCL, i.e. more than 1% of DLBCL cells CD30 positive(central pathology review results not required to enter patient into the study), according to the WHO classification 2008:\n\n  * CD30 positive DLBCL, including EBV positive DLBCL\n  * CD30 positive primary mediastinal B-cell lymphoma\n* Primary refractory to or in first relapse after first line therapy with R-CHOP or R-CHOP-like therapy\n\n  * Relapse is defined as biopsy confirmed CD30 positive DLBCL after a complete response. The relapse must be histologically confirmed. In case a surgical biopsy is not possible, at least confirmation by FNA biopsy is required\n  * Refractory disease is defined as:\n\n    1. progressive disease during first line therapy, In this case biopsy confirmation of CD30 positive DLBCL is preferred but not required\n    2. stable disease after at least 3 cycles of first line therapy, In this case biopsy confirmation of CD30 positive DLBCL is preferred but not required\n    3. PR after at least 6 cycles of first line therapy, or in the case of stage I-II disease after at least 3 cycles of therapy and definitive involved field radiotherapy. In this case refractory disease must be histologically confirmed\n* Age ≥ 18 years (upper age limit for ASCT at the discretion of the participating center)\n* Measurable disease: on CT scan at least 1 lesion\u002Fnode with a long axis of \\> 1.5 cm and at least one positive lesion on 18F-FDG PET scan\n* WHO performance status 0-2, status 3 only if disease related (see appendix C)\n* Adequate hepatic function: total bilirubin ≤ 1.5 times ULN (unless due to lymphoma involvement of the liver or a known history of Gilbert's syndrome as defined by \\> 80% unconjugated bilirubin) and ALAT\u002FASAT ≤ 3 times ULN (unless due to lymphoma involvement of the liver; in that case ALAT\u002FASAT may be elevated up to 5 times ULN)\n* Adequate renal function: GFR \\> 60 ml\u002Fmin as estimated by the Cockroft\\&Gault formula at rehydration: CrCL = (140-age \\[in years\\] x weight \\[kg\\] (x 0.85 for females) \u002F (0.815 x serum creatinine \\[μmol\u002FL\\])\n* Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5x109\u002FL and platelet count ≥ 100 x 109\u002FL, unless caused by diffuse bone marrow infiltration by the NHL\n* Hemoglobin must be ≥ 8 g\u002FdL (5.0 mmol\u002FL), transfusion is allowed\n* Eligible for high-dose chemotherapy and ASCT\n* Resolution of relevant toxicities from first-line therapy\n* Life expectancy of \\> 3 months with treatment\n* Negative pregnancy test at study entry, if applicable\n* Female patient is either post-menopausal for at least 1 year before screening visit or surgically sterile or if of childbearing potential, agrees to practice 2 effective methods of contraception, at the same time, or agrees to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months after the last dose of study drug\n* Male patients, even if surgically sterilized, (i.e. status post vasectomy) agree to practice effective barrier contraception, or agrees to completely abstain from heterosexual intercourse, during the entire study period and through 12 months after the last dose of study drug\n* Written informed consent\n* Patient is capable of giving informed consent\n\nExclusion Criteria:\n\n* Peripheral sensory or motor neuropathy grade ≥ 2\n* Known cerebral or meningeal disease (NHL or any other etiology), including signs and symptoms of progressive multifocal leukoencephalopathy (PML)\n* Symptomatic neurological disease compromising normal activities of daily living or requiring medications\n* Transformed lymphoma\n* DLBCL after organ transplantation\n* Immunodeficiency-associated B-cell lymphoproliferative disease\n* Use of other investigational agents within at least 5 half-lives of the most recent agent used prior to study entry\n* Treatment with myelosuppressive chemotherapy or biological therapy ≤ 4 weeks before study entry\n* Female patients who are breast feeding\n* History of another malignancy less than 3 years before study inclusion, or previously diagnosed with another malignancy and have evidence of residual disease, with the exception of non-melanoma skin cancer, completely resected melanoma TNMpT1 and carcinoma in situ of the uterine cervix\n* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin\n* Active hepatitis B or C infection as defined by positive serology and transaminitis. Non-active hepatitis B carriers or anti-HBc positive patients may be included if protected with lamuvidine or entecavir (see 9.4)\n* HIV positivity\n* Radiation therapy within 8 weeks prior to start of protocol treatment. Emergency radiation therapy is allowed, as long as measurable disease (at non-irradiated sites) persists\n* Patients with a serious psychiatric disorder that could, in the investigator's opinion, potentially interfere with the completion of treatment according to protocol\n* Major organ dysfunction, unless NHL-related\n* Patients who have any severe and\u002For uncontrolled medical condition or other conditions that could affect their participation in the study such as:\n\n  * Known history of symptomatic congestive heart failure (NYHA III, IV, appendix E), myocardial infarction ≤ 6 months prior to first study drug\n  * Evidence of current serious uncontrolled cardiac arrhythmia, angina pectoris, electrocardiographic evidence of acute ischemia or active conduction system abnormalities\n  * Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction \\\u003C45%\n  * Severely impaired pulmonary function as defined as spirometry and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% or less of the normal predicted value and\u002For O2 saturation that is 90% or less at rest on room air\n* Thyroid abnormalities when thyroid function cannot be maintained in the normal range by medication\n* Current participation in another clinical trial interfering with this trial\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Claustrophobia to the extent that PET-CT is impossible",{"count":619,"type":20},37,[82,23],"Patients with CD30 positive DLBCL, primary refractory or in first relapse after R-CHOP or R-CHOP-like therapy will receive brentuximab vedotin in combination with R-DHAP, followed in responsive patients by high dose chemotherapy and ASCT.",[28],"2020-12-09",{"date":625,"type":39},"2020-12-10",{"date":627,"type":39},"2018-03-05",{"date":629,"type":20},"2027-02",{"name":631,"class":95},"Stichting Hemato-Oncologie voor Volwassenen Nederland",{"id":633,"slug":634,"hasResults":11,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":639,"enrollmentInfo":640,"targetDuration":4,"studyType":21,"phases":642,"briefSummary":643,"conditions":644,"keywords":647,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":47},"100395716","phase-1-lenalidomide-in-combination-with-r-da-epoch-in-patients-with-untreated-dlbcl-with-myc-rearrangement-100395716","NCT04432714","Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement","A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement","Inclusion Criteria:\n\n1. Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma.\n2. ECOG PS 0-2\n3. Age 18-60 years old\n4. Expected survival ≥ 12 weeks\n5. A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)\n6. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures\n2. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons\n3. Previous exposure to any anti-tumor therapy\n4. Poor hepatic and\u002For renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr# 50 mL\u002Fmin unless these abnormalities were related to the lymphoma\n5. History of DVT or PE within past 12 months\n6. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109\u002FL or platelet count less than 75×109\u002FL, unless caused by bone marrow infiltration\n7. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia\n8. CNS or meningeal involvement\n9. Known sensitivity or allergy to investigational product\n10. Major surgery within three weeks\n11. Patients receiving organ transplantation\n12. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer\n13. Presence of Grade III nervous toxicity within past two weeks\n14. Active and severe infectious diseases\n15. Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment\n16. In any conditions which investigator considered ineligible for this study\n17. Patients with histological transformation.","60 Years",{"count":641,"type":20},81,[82,23],"The prognosis of DLBCL with MYC rearrangement is dismal. Previous study showed that lenalidomide in combination with R-CHOP showed promising therapeutic activity and that R-DA EPOCH was superior compared to R-CHOP regimen in this cohort of patients. The investigators therefore design this phase I\u002FII study to investigate the safety and efficacy of lenalidomide in combination with R-DA EPOCH in patients with untreated MYC-rearranged DLBCL.",[28,645,646],"Untreated","MYC Gene Rearrangement",[28,648,403,649],"MYC Gene rearrangement","R-DA EPOCH","2020-06-13",{"date":652,"type":39},"2020-06-16",{"date":654,"type":20},"2020-06-09",{"date":656,"type":20},"2026-12-31",{"name":94,"class":95}]