[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"double-expressor-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:double-expressor-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,68,98,126],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100485408","phase-2-loncastuximab-tesirine-and-rituximab-followed-by-da-epoch-r-for-treating-patients-with-high-risk-diffuse-large-b-cell-lymphoma-100485408",false,"NCT05600686","Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma","A Phase 2 Study of Loncastuximab Tesirine and Rituximab (Lonca-R) Followed by DA-EPOCH-R in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed untreated DEL and DHL diffuse large B-cell lymphoma (DLBCL) meeting the World Health Organization (WHO) criteria for DEL - MYC greater than 40% and BCL2 greater than 50% by immunohistochemistry, or high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements (double-hit and\u002For triple-hit are included)\n* Measurable disease by CT or PET\u002FCT scan, with one or more sites of disease \\>= 1.5 cm in longest dimension\n* Age \\>= 18 years at time of consent\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Life expectancy \\>= 6 months\n* Leukocytes \\>= 2,500\u002FuL\n* Absolute neutrophil count \\>= 1,000\u002FuL\n* Platelets \\>= 100,000\u002FuL\n* Hemoglobin \\>= 8 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\\\u003C 3 x ULN may be enrolled)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x ULN (AST and\u002For ALT =\\\u003C 5 x ULN for patients with liver involvement)\n* Alkaline phosphatase =\\\u003C 2.5 x ULN (=\\\u003C 5 x ULN for patients with documented liver involvement or bone metastases)\n* Creatinine clearance \\>= 30 mL\u002Fmin by Cockcroft-Gault\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose)\n* Transthoracic echocardiography (TTE) or multigated acquisition scan (MUGA) ejection fraction greater than 40%\n* Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 7 months after the last dose of study drug\n* Ability to understand and the willingness to sign a written informed consent document\n* Human immunodeficiency virus (HIV) infected patients:\n\n  * No history of acquired immunodeficiency syndrome (AIDS)-defining conditions other than lymphoma or history of CD4+ T-cells below 200\u002Fmm\\^3 prior to beginning combination anti-retroviral therapy (ART)\n  * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n  * At time of study entry CD4+ T-cells must have recovered from prior lymphoma therapy to \\>= 250\u002Fmm\\^3\n  * At the time of study entry, the HIV viral load must be undetectable by standard laboratory assay\n  * During prior lymphoma therapy, patients must not have experienced documented infections attributed to the HIV positive (+) status\n  * No history of non-adherence to ART and willing to adhere to ART while on study\n  * Antiretroviral drugs with overlapping or similar toxicity profiles as study agents not allowed\n\nExclusion Criteria:\n\n* Current\u002F prior use of:\n\n  * Lymphoma treatment, except for:\n\n    * 1 cycle of DA-EPOCH-R or rituximab, cyclophosphamide, doxorubicin (Adriamycin) vincristine (Oncovin) and prednisolone (R-CHOP)\n    * Radiotherapy \\> 2 weeks of initiating study treatment\n    * Nitrosoureas or mitomycin C \\> 6 weeks of initiating study treatment\n    * Steroid treatment for DLBCL or steroid monotherapy to stabilize disease while awaiting fluorescence in situ hybridization (FISH)\n    * Other cancer therapies (e.g., prostate, breast hormonal-based therapy) per the principal investigator's discretion\n  * Anthracycline greater than 50 mg\u002Fm\\^2 (total lifetime) for a prior malignancy\n  * Complementary and alternative medications (CAM) within 1 week prior to initiating study treatment\n  * Treatment with any other investigational agent for any indication within 3 weeks prior to initiating study treatment\n  * Loncastuximab tesirine or rituximab with progression within 6 months of initiating study treatment\n  * Oral or intravenous (IV) antibiotics within 2 weeks prior to initiating study treatment. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible\n  * Live, attenuated influenza vaccine within 4 weeks prior to initiating study treatment\n* Immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor, such as anti-tumor necrosis factor \\[TNF\\] agents) within 14 days prior to initiating study treatment. The following are exceptions to this criterion:\n\n  * Steroids\n  * Bisphosphonate therapy for symptomatic hypercalcemia or for other reasons (e.g., bone metastasis or osteoporosis)\n* Known uncontrolled central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement\n* History of hypersensitivity to anti-CD19 antibodies, loncastuximab tesirine, or any agents used in DA-EPOCH-R\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in study\n* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)\n* Breastfeeding or pregnancy\n* Clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; or inherited liver disease\n\n  * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \\[HbsAg\\] test and a positive anti-HBc \\[antibody to hepatitis B core antigen\\] antibody test) are eligible\n  * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\n* Documented eczema, psoriasis, or lichen simplex chronicus of vitiligo with dermatologic manifestations (e.g., patients with psoriatic arthritis would be excluded), unless the following apply:\n\n  * Affected skin covers less than 10% of body surface area (BSA)\n  * Disease is well controlled at baseline and only requires low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\n  * No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)\n* Known active tuberculosis (TB)\n* Severe infections within 4 weeks prior to initiating study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Major surgical procedure within 28 days prior to initiating study treatment or anticipation of need for a major surgical procedure during the course of the study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial evaluates whether loncastuximab tesirine and rituximab followed by dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone works to treat patients with high risk diffuse large B-cell lymphoma. Loncastuximab tesirine is a monoclonal antibody called loncastuximab, linked to a drug called tesirine. It is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs such as doxorubicin, vincristine, and cyclophosphamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving loncastuximab tesirine and rituximab in combination with dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone may be more effective at treating high risk diffuse large B-cell lymphoma patients than standard treatments.",[26,27,28,29],"Double-Expressor Lymphoma","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements","RECRUITING","2026-06-25",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2023-05-24",{"date":38,"type":20},"2027-12-15",{"name":40,"class":41},"University of California, Davis","OTHER",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100598300","phase-1-testing-the-safety-of-anti-cancer-drug-cx-5461-pidnarulex-in-treating-lymphoma-with-specific-changes-in-the-myc-gene-100598300","NCT07069699","Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene","Phase 1b\u002F2 Trial of Pidnarulex in MYC Aberrant Lymphoma","Inclusion Criteria:\n\n* Patients must have one of the following subtypes of aggressive B-cell non-Hodgkin lymphomas: double-expressor lymphoma (DEL), high-grade B-cell lymphoma (HGBL) with MYC and BCL2 and\u002For BCL6 rearrangement, or Burkitt lymphoma (BL). Eligible patients must have received at least two prior lines of treatment for diffuse large B-cell lymphoma (DLBCL) or at least one prior line of therapy for Burkitt Lymphoma and must have disease for which no standard curative or palliative treatment options exist or remain effective (Quin et al., 2016)\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of CX-5461 (Pidnarulex) in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%). ECOG 3 is allowed if directly related to lymphoma per treating provider\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 50,000\u002FmcL\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN)\n\n  * Patients with documented Gilbert's syndrome may be included if total bilirubin is ≤ 3 × ULN and direct bilirubin is within normal limits\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional upper limit of normal (ULN)\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F, calculated by multiplying the estimated (e)GFR (mL\u002Fmin\u002F1.73 m\\^2) by the individual's body surface area (BSA, calculated using an accepted formula) and dividing by 1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patients with cytopenia related to abnormal bone marrow function in the setting of bone marrow involvement with lymphoma or post chimeric antigen receptor (CAR) T-cell are allowed to enroll if deemed safe by treating provider\n* Patients without clinical evidence of central nervous system (CNS) lymphoma\n* The effects of CX-5461 (Pidnarulex) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) 14 days prior to study entry and for the duration of study participation and for at least 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women should not breastfeed while taking CX-5461 (Pidnarulex) and for 6 months after cessation of treatment. Men treated or enrolled on this protocol must also agree to use adequate contraception 14 days prior to the study, for the duration of study participation, and 6 months after completion of CX-5461 (Pidnarulex) administration. Women of childbearing age should not donate egg(s) and men should not donate sperm for the duration of study participation and 6 months after completion of the last dose CX-5461 (Pidnarulex)\n* Willingness to provide blood and biopsy samples for research purposes\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients must have recovered from clinically significant adverse events (AEs) of their most recent cancer immunotherapy to grade 1 or less (with the exception for alopecia or lymphopenia)\n* Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity of CX-5461 (Pidnarulex) will be determined based on their potential to interact with the CYP3A4 isozyme. Specifically, subjects taking strong CYP3A4 inhibitors or strong CYP3A4 inducers will be excluded from participation in the trial. For medications or substances not listed, or in cases of uncertainty, the Principal Investigator may consult with a medical expert or a pharmacologist to make an informed decision regarding eligibility\n* Patients with a baseline corrected QT (QTc) interval \\> 480 msec\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CX-5461 (Pidnarulex)\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because CX-5461 (Pidnarulex) is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with CX-5461 (Pidnarulex), breastfeeding should be discontinued if the mother is treated with CX-5461 (Pidnarulex)",{"count":51,"type":20},50,[53,23],"PHASE1","This phase Ib\u002FII trial tests the safety, side effects, best dose and how well giving CX-5461 works for the treatment of patients with B-cell non-Hodgkin lymphoma. CX-5461 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CX-5461 may be safe, tolerable and\u002For effective in treating patients with B-cell non-Hodgkin lymphoma.",[56,26,27],"Burkitt Lymphoma","2026-05-12",{"date":59,"type":34},"2026-05-13",{"date":61,"type":20},"2026-10-13",{"date":63,"type":20},"2030-01-31",{"name":65,"class":66},"National Cancer Institute (NCI)","NIH",4,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100632240","phase-3-a-study-comparing-c-pola-r-chpx-with-cr-chop-in-the-treatment-of-previously-untreated-del-under-the-guidance-of-genotyping-100632240","NCT07511114","A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyping","A Prospective, Open-label, Multicenter, Randomized Controlled Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated Double-expression Diffuse Large B-cell Lymphoma Under the Guidance of Genotyping","Inclusion Criteria:\n\n* 1\\. Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;\n* 2\\. Simultaneous expression of MYC and BCL2, according to the WHO standard for immunohistochemistry: MYC ≥ 40%, BCL2 ≥ 50%\n* 3\\. Age ≥ 18 years old and ≤ 75 years old;\n* 4\\. ECOG performance status score of 0, 1, or 2;\n* 5\\. International Prognostic Index (IPI) \\> 1\n* 6\\. No history of malignant tumor; no concurrent occurrence of other tumors;\n* 7\\. Patients with an expected lifespan of at least 6 months, as determined by the researcher;\n* 8\\. The patient or their legal representative must provide written informed consent before undergoing any special examinations or procedures in the study.\n\nExclusion Criteria:\n\n* 1\\. Have previously received systemic or local treatments, including chemotherapy;\n* 2\\. Have previously undergone autologous stem cell transplantation;\n* 3\\. Previously had a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;\n* 4\\. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;\n* 5\\. Primary central nervous system lymphoma;\n* 6\\. Left ventricular ejection fraction (LVEF) is less than or equal to 50%;\n* 7\\. Laboratory test values during screening: (unless caused by lymphoma); A. Neutrophil count \\\u003C1.5\\*10\\^9\u002FL; B. Platelet count \\\u003C 75 x 10\\^9\u002FL; C. ALT or AST is 2 times higher than the upper limit of normal, and AKP and bilirubin are 1.5 times higher than the upper limit of normal; D. Creatinine level is higher than 1.5 times the upper limit of normal;\n* 8\\. Other concurrent and uncontrolled medical conditions that the researcher believes will affect the patient's 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\\. Individuals infected with HIV.\n* 12\\. Patients with positive HBsAg test results must undergo HBV DNA testing and can only be enrolled after becoming negative. Additionally, if the HBsAg test result is negative but the HBcAb test result is positive (regardless of the HBsAb status), HBV DNA testing is also required. If the result is positive, treatment must be administered until becoming negative before enrollment;","75 Years",{"count":77,"type":20},156,[79],"PHASE3","Evaluate the efficacy and safety of C Pola R-CHP+X compared to CR-CHOP in the treatment of previously untreated patients with DEL",[82,83],"DLBCL - Diffuse Large B Cell Lymphoma","Double Expressor Lymphoma",[85,86,87],"DLBCL","DEL","Chidamide","NOT_YET_RECRUITING","2026-03-31",{"date":91,"type":34},"2026-04-06",{"date":89,"type":20},{"date":94,"type":20},"2030-03-31",{"name":96,"class":41},"Ruijin Hospital",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":97},"100567892","phase-2-rlc-followed-by-cr-chop-in-elderly-patients-with-newly-diagnosed-del-100567892","NCT06674096","RLC Followed by CR-CHOP in Elderly Patients with Newly-diagnosed DEL","Rituximab，Lenalidomide and Chidamide Followed by CR-CHOP in Elderly Patients with Newly-diagnosed Double-expressor Lymphoma","Inclusion Criteria:\n\n* 1\\. Untreated DLBCL patients confirmed by histopathology 2. Immunohistochemistry showed positive expression of MYC and BCL2 protein (double expressor lymphoma, MYC≥40%, BCL2≥50%) 3. age over 70 years old or age ≥65 years old and ECOG score ≥2 points, both male and female 4. Having at least one evaluable lesion, defined as having at least one lymphadenopathy with a maximum diameter \\> 1.5 cm, or at least one extranodal lesion with a maximum diameter \\> 1.0 cm, and at least two vertical diameters that can be accurately measured.\n\n  5\\. ECOG PS≤3 6. Expected survival time ≥3 months 7. voluntary participation in clinical research; Fully understand and understand the study and sign the informed consent; Willingness to follow and ability to complete all research steps.\n\nExclusion Criteria:\n\n* 1\\. The pathological subtypes were PCNSL, PMBCL, EBV-positive DLBCL and HGBL 2. Hemophagocytic syndrome accompanied the diagnosis 3. Central nervous system involvement is secondary to lymphoma 4. Are participating in other clinical studies, or the first study drug is administered less than 4 weeks after the end of treatment in the previous clinical study 5. HIV infection 6. Major surgery was performed within 28 days prior to study start 7. Any active infection that required systematic anti-infective therapy developed within 14 days prior to study initiation 8. The patients considered by the investigator to be unsuitable for participating in this study","65 Years",{"count":107,"type":20},44,[23],"This is a prospective, single-arm, multicenter clinical study to evaluate the efficacy and safety of chidamide, rituximab combined with lenalidomide sequential immunochemotherapy in the treatment of newly diagnosed elderly double-expressor diffuse large B-cell lymphoma.",[111],"Double-expressor Lymphoma",[85,86,113,114,115,116],"rituximab","lenalidomide","chidamide","chemo-free","2024-11-15",{"date":119,"type":34},"2024-11-18",{"date":121,"type":20},"2024-11-06",{"date":123,"type":20},"2030-06-30",{"name":125,"class":41},"Zhejiang Cancer Hospital",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100566205","mechanism-investigation-of-r-chop-regimen-or-tucidinostat-plus-r-chop-cr-chop-regimen-in-the-treatment-of-bcl2myc-protein-double-expressor-lymphoma-100566205","NCT06652152","Mechanism Investigation of R-CHOP Regimen or Tucidinostat Plus R-CHOP (CR-CHOP) Regimen in the Treatment of BCL2\u002FMYC Protein Double Expressor Lymphoma","Mechanism Investigation of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) Regimen or Tucidinostat Plus R-CHOP (CR-CHOP) Regimen in the Treatment of BCL2\u002FMYC Protein Double Expressor Lymphoma","DEL Biomarker","Inclusion Criteria:\n\n* Each potential subject must satisfy all of the following criteria to be enrolled in the study.\n\nMale or female, age ≥ 18 years and ≤80 years. No prior treatment for diffuse large B cell lymphoma(DLBCL), including hemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy) Histological or cytological confirmation of DLBCL CD20-positive DLBCL; Myc≥40% as well as Bcl-2≥50% through immunohistochemistry; Not with double (BCL-2 and c-MYC gene rearrangement) or triple (BCL-2, BCL-6, and c-MYC gene rearrangement) hit by FISH.\n\nThe verification of DLBCL will be based on local pathology report.15-20 unstained slides must be sent to the central laboratory for retrospective confirmation.\n\n4.At least one positive lesion according to the Lugano Classification by fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography(CT).\n\n5.Lymphoma International PrognosisIndex (IPI) score of 2,3,4. 6.Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2. 7.Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry):\n\n(1)Hematology values:Hemoglobin (Hb)≥90g\u002FL ; Absolute neutrophil count (ANC) ≥1.5×109\u002FL ; platelets ≥90×109\u002FL (2)Biochemical values: Serum creatinine ≤1.5×upper limit of normal(ULN); Total bilirubin ≤1.5 × ULN; Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤2.5×ULN(ALT,AST≦5×ULN if liver involved).\n\n8.Expected survival≥6 months. 9.All patients must have signed an informed consent document.\n\nExclusion Criteria:\n\n* Any potential subject who meets any of the following criteria will be excluded from participating in the study.\n\nPresence of CNS involvement. Patients with primary DLBCL of the central nervous system (CNS),or secondary lymphoma of the central nervous system, or Primary mediastinal (thymic) large B-cell lymphoma, or Primary effusion lymphoma, or B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma, or Primary cutaneous DLBCL, leg type, or indolent lymphoma, or Burkitt lymphoma, or EBV-positive mucocutaneous ulcer, or DLBCL associated with chronic inflammation, or Lymphomatoid granulomatosis, or Intravascular large B-cell lymphoma, or ALK-positive large B-cell lymphoma, or Plasmablastic lymphoma, or HHV8-positive DLBCL, NOS, or primary testicular DLBCL.\n\nPatients with transformed lymphoma. History of organ transplantation or hematopoietic stem cell transplantation. Patients planned for autologous or allogeneic transplant as consolidation in first line.\n\nPatients with any other malignancy, except patients with a history of curatively treated basal or squamous cell carcinoma or in situ carcinoma of the cervix at any time prior to the study are eligible.\n\nPrior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody within 5 years of the start of Cycle 1.\n\nPrior use of any monoclonal antibody within 3 months of the start of Cycle 1. Any investigational therapy within 3 months prior to the start of Cycle 1. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.\n\nContraindication to any of the individual components of CHOP.\n\nCorticosteroid use \\> 30 mg\u002Fday of prednisone or equivalent, for purposes other than lymphoma symptom control:\n\nPatients receiving corticosteroid treatment with ≤ 30 mg\u002Fday of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to randomization (Cycle 1, Day 1).\n\nIf glucocorticoid treatment is urgently required for lymphoma symptom control prior to the start of study treatment, prednisone 100 mg or equivalent could be given for a maximum of 5 days, but all tumor assessments must be completed prior to start of glucocorticoid treatment.\n\n13.Ongoing serious central nervous system disease or peripheral neuropathy, such as progressive multifocal leukoencephalopathy.\n\n14.Have uncontrolled or significant cardiovascular disease, including: Grade II or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (New York Heart Association Functional Classification ) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% during screening stage.\n\nPrimary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al).\n\nHistory of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male), QTc≥470ms（female）at screening.\n\nSymptomatic coronary heart disease requiring treatment. Any other cardiovascular disease which is inappropriate for the study according to investigators' judgment.\n\n15.History of interstitial lung disease(ILD), or with ongoing signs and symptoms by CT or MRI at the time of screening.\n\n16.Patients with factors that could affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy.\n\n17.History of deep vein thrombosis or pulmonary embolism. 18.History of active bleeding within 2 months prior to the start of Cycle 1;or patients receiving anticoagulation therapy; or patients with evidence of bleeding potential according to investigators' judgment ( esophageal varices, active ulcer, or fecal occult blood test positive etc. ). Patients with bleeding led by lymphoma according to investigators' judgment are eligible.\n\n19.6 weeks or less from the last major surgery that involved crucial organs, or with any other factors impede postoperative recovery according to investigators' judgment.\n\n20.Known active infection, or active and uncontrolled hepatitis B infection(HBV), hepatitis C Virus(HCV), human immunodeficiency virus (HIV)\u002FAIDS (Acquired Immune Deficiency Syndrome), or any other serious infection. (active infection defined as any major episode of infection requiring systemic treatment; Patients with occult or prior HBV may be included if HBV DNA is undetectable.) 21.Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or limit compliance with study requirements\u002F treatment.\n\n22.Drug or alcohol abuse. 23.Women of childbearing potential and men who are sexually active not willing to practice a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials.These restrictions apply for 12 months after the last dose of rituximab or 12 weeks after the last dose of study drug, whichever is later. Pregnancy or lactation.\n\n24.Any other condition which is inappropriate for the study according to investigators' judgment.","80 Years",{"count":136,"type":20},400,"OBSERVATIONAL","This study is trying to explore the mechanism of R-CHOP regimen or tucidinostat plus R-CHOP (CR-CHOP) regimen in the treatment of BCL2\u002FMYC protein double expressor lymphoma.",[140,83],"Diffuse Large B Cell Lymphoma (DLBCL)",[142,143,144,145,146,147],"diffuse large B cell lymphoma","double expressor lymphoma","BCL2","MYC","tucidinostat","biomarker","2024-10-21",{"date":150,"type":34},"2024-10-22",{"date":152,"type":20},"2024-10-30",{"date":154,"type":20},"2025-12-30",{"name":96,"class":41}]