[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"newly-diagnosed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:newly-diagnosed":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,78,106,127,156,175,197,219],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100636146","phase-4-study-of-the-effectiveness-and-safety-of-daunorubicin-idarubicin--silibinin-in-treating-newly-diagnosed-aml-non-m3-100636146",false,"NCT07561892","Study of the Effectiveness and Safety of Daunorubicin \u002FIdarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3).","Prospective Randomized Study of the Effectiveness and Safety of Chemotherapy Protocols Containing Daunorubicin \u002FIdarubicin ± Silibinin in Treating Newly Diagnosed AML (Non-M3)","AML","Inclusion Criteria:\n\n1. Newly diagnosed acute leukemia(non-M3)confirmed according to the 2018 WHO classification criteria for the diagnosis and classification of acute leukemia;\n2. Suitable for standard chemotherapy regimens containing idarubicin\u002Fdaunorubicin;\n3. Patients with an expected survival time of at least 3 months as determined by the investigator;\n4. Voluntarily agree to participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. History of other malignant tumors concurrently or previously diagnosed malignancies not under control;\n2. Participation in other clinical trials within one month prior to screening;\n3. Presence of uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases, or other such conditions;\n4. Other uncontrolled diseases that the investigator considers inappropriate for inclusion;\n5. Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol;\n6. Pregnant or breastfeeding women;\n7. History of liver cirrhosis, or current active liver disease or biliary disease;\n8. HIV-positive individuals;\n9. Any other conditions that, in the investigator's judgment, may prevent the subject from completing the study or pose significant risk to the subject.","ALL","18 Years","65 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Silibinin is the major active component of silymarin, a commonly used hepatoprotective agent. It stabilizes hepatocyte membranes, preserves cellular integrity, and accelerates DNA synthesis in liver cells. Clinically, it is widely used in the treatment of chronic persistent hepatitis, chronic active hepatitis, early-stage liver cirrhosis, and hepatotoxicity. Moreover, it has been reported to inhibit the growth and differentiation of various cancer cells, including hepatocellular carcinoma, prostate cancer, breast cancer, and cervical cancer.\n\nBased on these preclinical findings, we aim to evaluate the efficacy and safety of combining silybinin with the standard first-line idarubicin\u002Fdaunorubicin-based regimen in the treatment of newly diagnosed acute leukemia(non-M3)in a clinical setting.",[28,29,30],"Acute Myeloid Leukemia","Newly Diagnosed","Chemotherapy Effect",[15,32,33,34,35],"newly diagnosed","Silybin","daunorubicin","Idarubicin","RECRUITING","2026-04-27",{"date":39,"type":40},"2026-05-01","ACTUAL",{"date":42,"type":40},"2022-04-01",{"date":44,"type":22},"2026-12-31",{"name":46,"class":47},"Fujian Medical University Union Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100261018","identify-barriers-to-allogeneic-hematopoietic-stem-cell-transplantation-in-patients-with-newly-diagnosed-and-relapsed-acute-leukemia-100261018","NCT02677064","Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia","Observational Study to Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia, Myelodysplastic Syndrome and Myelproliferative Neoplasms","Inclusion Criteria:\n\n* Patients with newly diagnosed or relapsed acute leukemia. Patients undergoing reinduction due to primary induction failure are also eligible. Patients with acute leukemia will be enrolled to Arm A\n* Patients with diagnosis of MDS, MPN and MDS\u002FMPN overlap who meet any of the following criteria (based on NCCN guidelines):\n* Clinically significant cytopenia of at least 2 cell lines affected; Hgb\\\u003C10,\n* Platelet\\\u003C100,000, absolute neutrophil count\\\u003C1000\n* Bone marrow blasts \\>5% and any level of circulating blasts\n* Evidence of disease progression or no response to hypomethylating agents\u002Fimmunosuppressive treatment or a clinical trial.\n* IPSS Intermediate-1 and higher\n* IPSS-R intermediate and higher\n* All cases of therapy related MDS with excess blasts\n* In patients with Myelofibrosis: Low risk disease by DIPSS with either refractory, transfusion dependent anemia, circulating blasts cells greater than 2%; or adverse cytogenetics and any patient with DIPSS-intermidiate 1 and higher.\n* Patients with acute leukemia or MDS\u002FMPN who relapse after first allografts. Patients with post-transplant relapse will be enrolled to Arm C.\n* Patients 18 years of age or older and 80 years of age or younger\n* For the purposes of this protocol \"relapse\" is defined as re-emergence of the initial abnormal myeloid blast population (or blast equivalent) comprising 5% or more of marrow WBC or any amount prompting a therapeutic intervention targeting relapsed disease, including, but not limited to withdrawal of immunosuppression, targeted therapies, chemotherapy, etc.\n\nExclusion Criteria:\n\n* Patients with polycythemia vera (PV) and essential thrombocytosis (ET)","80 Years",{"count":58,"type":22},1365,"OBSERVATIONAL","The investigators are doing this research study to assess the percentage of patients receiving stem cell transplantation for the type of blood cancer you have. They want to know how many patients get a transplant and why some patients do get a transplant while others do not. Also they want to explore why some patients elect not to undergo stem cell transplantation, when it is recommended by their physicians.",[62,29,63],"Acute Leukemia","Relapsed",[65,66,67],"Allogeneic Hematopoietic Stem Cell Transplantation","Identify Barriers","16-024","2026-01-16",{"date":70,"type":40},"2026-01-20",{"date":72,"type":4},"2016-02",{"date":74,"type":22},"2027-02",{"name":76,"class":47},"Memorial Sloan Kettering Cancer Center",3,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":48},"100557010","phase-2-comparison-of-va-venetoclax-azacitidine-vacl-va-cladribine-vach-va-chidamide-and-alternating-vaclvach-in-newly-diagnosed-acute-myeloid-leukemia-100557010","NCT06532552","Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl\u002FVACh in Newly Diagnosed Acute Myeloid Leukemia","Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl\u002FVACh in Newly Diagnosed Adult Acute Myeloid Leukemia Patients Ineligible for Intensive Therapy or Declining: A Prospective, Multi-center, Randomized, Controlled Phase II Study","Inclusion Criteria:\n\nA subject will be eligible for study participation if he\u002Fshe meets the following criteria within 21 days prior to randomization.\n\n1. Subject must have confirmation of previously untreated AML by World Health Organization (WHO) criteria, and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities. Prior therapy with hydroxyurea or a total dose of cytarabine no more than 0.5g (for emergency use for stabilization) is allowed.\n2. Subject must be≥18 years of age with at least one of the following conditions:\n\n   A)≥60 years of age; B) Patients aged \\\u003C 60 years who are unsuitable for standard induction therapy（Any other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy); C) The patient refused the conventional intensive chemotherapy.\n3. Adequate organ function as defined below:\n\n   A)liver function (bilirubin≤2mg\u002FdL, aspartate transaminase (AST) and\u002For alanine transaminase (ALT)≤3 x ULN).\n\n   Unless liver enzyme abnormalities are determined by the treating MD and PI to be due to leukemic infiltration.\n\n   B)kidney function (creatinine≤1.5xULN ).\n4. ECOG performance status of ≤ 2.\n5. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n7. Patient must have a projected life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n1. Subject has a history of other malignancies prior to study entry, with the exception of:\n\n   A) Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; B) Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; C) Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n2. Subject has acute promyelocytic leukemia, subject has history of myeloproliferative neoplasm \\[MPN\\] including myelofibrosis, essential thrombocythemia, polycythemia vera, CML with or without BCR-ABL1 translocation, BCR\u002FABL positive AML.\n3. Patient has known active central nervous syster (CNS) involvement with AML.\n4. Subject has a white blood cell count\\> 25×10\\^9\u002FL. (Hydroxyurea is permitted to meet this criterion.)\n5. Prior therapy with venetoclax, Cladribine, hypomethylating agents (HMAs), Chidamide or Chimeric Antigen Receptor T cell therapy, experimental therapies for MDS or AML.\n6. Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.\n7. Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required.)\n8. Subject has received strong and\u002For moderate CYP3A inducers within 7 days prior to the initiation of study treatment.\n9. Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.\n10. Subject has a cardiovascular disability status of New York Heart Association Class≥2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.\n11. Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his\u002Fher participating in this study.\n12. Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).\n13. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months (Hepatitis B or C testing is not required). Subjects with serologic evidence of prior vaccination to HBV \\[i.e., HBs Ag-, and anti-HBs+-\\] may participate)",{"count":86,"type":22},172,[88],"PHASE2","This prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult acute myeloid leukemia (AML) patients ineligible for intensive therapy or declining. Cladribine is a purine analogue widely used in hematologic malignancies. The monocytic leukemia stem cell is selective sensitivity to Cladribine. Chidamide, a newly designed selective histone deacetylase inhibitor, could down regulate myeloid cell leukaemia 1 (MCL1) expression in Venetoclax resistant AML cells. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance.",[91,29],"Acute Myeloid Leukemia, Adult",[93,94,95,96],"Venetoclax","Azacitidine","Cladribine","Chidamide","2025-11-18",{"date":99,"type":40},"2025-11-19",{"date":101,"type":40},"2024-07-29",{"date":103,"type":22},"2028-08-01",{"name":105,"class":47},"The First Affiliated Hospital of Soochow University",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":48},"100482747","phase-2-venetoclax-and-azacitidine-combined-with-chidamide-vac-for-the-treatment-of-newly-diagnosed-acute-monocytic-leukemia-100482747","NCT05566054","Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia","A Multicenter, Randomized, Controlled Clinical Trial of Venetoclax, Azacytidine Combined With Chidamide for the Treatment of Newly Diagnosed Acute Monocytic Leukemia Patients That Are Ineligible for Intensive Chemotherapy","Inclusion Criteria:\n\nConfirmation of acute monocytic leukemia( AML-M5) diagnosis by the French-American-British (FAB) Classification and\u002For characterized for expression of monocytic and myeloid differentiation markers, have a projected life expectancy of at least 12 weeks, previously untreated, and ineligible for treatment with intensive chemotherapy.\n\nPatients must be considered ineligible for induction therapy defined by the following:\n\n1. \\>= 60 years of age\n2. \\>=18 to 59years of age with at least one of the following comorbidities:\n\n   Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy:\n\n   (A)Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3. (B)Cardiac history of congestive heart failure requiring treatment or ejection fraction \\\u003C= 50% or chronic stable angina.\n\n   (C)Diffusing capacity of the lung for carbon monoxide (DLCO) \\\u003C= 65% or forced expiratory volume during the first second (FEV1) \\\u003C= 65%.\n\n   (D)Creatinine clearance \\>= 30 mL\u002Fmin to \\\u003C 45 mL\u002Fmin. (E)Moderate hepatic impairment with total bilirubin \\> 1.5 to \\\u003C= 3.0 × upper limit of normal (ULN).\n3. Must meet the laboratory requirements per the protocol.\n4. Female participant must not be pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 90 days after the last dose of study drug.\n5. Female participants of childbearing potential must agree to use at least 1 protocol-specified method of birth control and male participants, if sexually active with female partner(s) of childbearing potential, must agree to practice the protocol-specified contraception.\n6. Did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before enrollment;\n7. Other comorbidities that are not suitable for intensive chemotherapy;\n8. The patient refused to receive intensive chemotherapy;\n9. Ability to understand and willing to sign the informed consent for this trial.\n\nExclusion Criteria:\n\n1. Patients who are allergic to the study drug or drugs with similar chemical structures\n2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception\n3. Active infection\n4. Active bleeding\n5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment\n6. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met\n7. Liver function abnormalities (total bilirubin \\> 1.5 times the upper limit of the normal range, ALT\u002FAST \\> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT\u002FAST \\> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \\> 1.5 times the upper limit of the normal value)\n8. Patients with a history of clinically significant QTc interval prolongation (male \\> 450 ms; female \\> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment\n9. Urgery on the main organs within the past six weeks\n10. Drug abuse or long-term alcohol abuse that would affect the evaluation results\n11. Patients who have received organ transplants (excepting bone marrow transplantation)\n12. Patients not suitable for the study according to the investigator's assessment",{"count":114,"type":22},92,[88],"This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy",[118,29],"Acute Monocytic Leukemia",[96,94,93],{"date":121,"type":40},"2025-11-21",{"date":123,"type":40},"2022-03-01",{"date":125,"type":22},"2026-09-30",{"name":105,"class":47},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100598395","phase-2-car-t-vs-auto-sct-which-works-better-for-new-myeloma-patients-100598395","NCT07070934","CAR-T vs. Auto-SCT: Which Works Better for New Myeloma Patients?","A Multicenter, Open-label, Randomized Controlled Trial Comparing Anti-BCMA CAR-T Cell Therapy Versus Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Patients With Newly Diagnosed Multiple Myeloma","ASCTvsCAR-T","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive);\n2. Estimated life expectancy of more than 12 weeks;\n3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;\n4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);\n5. Karnofsky Performance Status (KPS) score \\> 50%.\n6. Eligible for ASCT.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or women planning to become pregnant within the next six months;\n2. Transduction efficiency of targeted lymphocytes \\\u003C10%, or expansion fold \\\u003C5× under CD3\u002FCD28 co-stimulation, as determined by feasibility screening;\n3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);\n4. Significant dysfunction of vital organs including the heart, lungs, or brain;\n5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study","70 Years",{"count":137,"type":22},60,[88],"This is a prospective study comparing anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of newly diagnosed multiple myeloma patients.",[141,29],"Multiple Myeloma",[141,143,144,145],"Eligible for ASCT","ASCT","CAR-T","NOT_YET_RECRUITING","2025-07-08",{"date":149,"type":40},"2025-07-17",{"date":151,"type":22},"2025-07-15",{"date":153,"type":22},"2028-07-31",{"name":155,"class":47},"Xuzhou Medical University",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":145,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":135,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":173,"leadSponsor":174,"locationsCount":4},"100598397","a-study-of-anti-bcma-car-t-therapy-in-newly-diagnosed-myeloma-patients-who-are-transplant-ineligible-100598397","NCT07070960","A Study of Anti-BCMA CAR-T Therapy in Newly Diagnosed Myeloma Patients Who Are Transplant-ineligible","A Multicenter, Open-label, Single-arm Clinical Study of Anti-BCMA CAR-T Cell Therapy in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive);\n2. Estimated life expectancy of more than 12 weeks;\n3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;\n4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);\n5. Karnofsky Performance Status (KPS) score \\> 50%.\n6. Ineligible for ASCT.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or women planning to become pregnant within the next six months;\n2. Transduction efficiency of targeted lymphocytes \\\u003C10%, or expansion fold \\\u003C5× under CD3\u002FCD28 co-stimulation, as determined by feasibility screening;\n3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);\n4. Significant dysfunction of vital organs including the heart, lungs, or brain;\n5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study",{"count":164,"type":22},35,[166],"NA","This is a prospective study of anti-BCMA CAR-T in transplant-ineligible patients with newly diagnosed multiple myeloma.",[141,29],[141,170,145],"transplant-ineligible",{"date":149,"type":40},{"date":151,"type":22},{"date":153,"type":22},{"name":155,"class":47},{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":48},"100547571","phase-4-treatment-of-high-risk-newly-diagnosed-multiple-myeloma-with-minimal-residual-disease-detection-100547571","NCT06409702","Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection","A Single-arm Prospective Study of the Treatment in High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection","Inclusion Criteria:\n\n1. patients with newly diagnosed multiple myeloma（may receive up to one course of a bortezomib-containing regimen for the urgent relief of bone pain, renal insufficiency, and hypercalcemia）;\n2. age ≥ 18 years;\n3. have an evaluable lesion; serum M protein ≥ 10 g\u002FL, or urinary light chain ≥ 200 mg\u002F24h, or involved serum free light chain (FLC) ≥ 100 mg\u002FL, and an extramedullary measurable tumor SPD: The diameter of cutaneous nodules can be measured with a manual tape, and extramedullary tumor SPD of extramedullary tumors is measured on a CT scan as the product of the largest dimension of the largest pendulous diameter of the lesion (minimum diameter of 5mm or more), parosteal lesions need to be in soft tissue outside the bone cavity to meet the above criteria. MRI measures the size of an extramedullary tumor as the product of the maximum pendulous diameter at the level of the largest area of the tumor (minimum diameter of 5mm or more)\n4. ECOG physical status score ≤ 2\n5. or have a high-risk karyotype abnormality recognized in mSMART or NCCN guidelines: t(4;14), t(14;16), t(14;20), Del(17p) or -17 and\u002For TP53 mutation, Del(1p32), 1q21 gain(amp), the coexistence of two adverse karyotypes as a double hit,and triple hit similarly defined\n6. or R-ISS stage 3\n7. or combined plasma cell leukemia (defined as peripheral blood sorted clonal plasma cells ≥ 5%)\n8. bone marrow function: neutrophils ≥ 1.0 x 109 \u002FL, platelets ≥ 70 x 109 \u002FL (if bone marrow plasma cells ≥ 50%, platelets ≥ 50 x 109 \u002FL)\n9. AST, ALT, ALP ≤ 3 × upper limit of normal value, serum bilirubin ≤ 2 times upper limit of normal value;\n10. serum creatinine clearance ≥ 40mL\u002Fmin\n11. negative pregnancy test for women of childbearing age; patients and their spouses must agree to use effective contraception during the treatment period and the following one-year period;\n12. Signed informed consent for chemotherapy. A legal representative will sign the informed consent form if the subject is unable to sign it due to impaired consciousness, paralysis of the subject's upper limbs, or inability to write.\n\nExclusion Criteria:\n\n1. monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, primary light chain amyloidosis with organ involvement.\n2. diagnosed or treated for another malignancy prior to pre-registration ≤ 1 year or previously diagnosed with another malignancy with evidence of any residual disease being treated.\n3. other co-morbidities that would interfere with the subject's ability to participate in the trial, e.g., uncontrolled infections, uncompensated cardiac or pulmonary disease, other synchronized chemotherapy or any adjuvant therapy considered investigational.\n4. peripheral neuropathy ≥ grade 1-2 with pain on clinical examination within 30 days prior to pre-registration\n5. major surgery within 14 days prior to pre-registration\n6. evidence of current uncontrolled cardiovascular disease, including uncontrolled hypertension (hypertension defined as SBP ≥ 140 mmHg and\u002For DBP ≥ 90 mmHg on 3 non-same day office measurements without antihypertensive medication), arrhythmias (prolonged QT interval, ventricular tachycardia, ventricular flutter, ventricular fibrillation, frequent ventricular premature beats (24 h ventricular premature load ≥ 15% of the total number of heart beats, atrioventricular block, heart rate \\\u003C30-40 bpm), congestive heart failure, unstable angina or myocardial infarction. New York Heart Association (NYHA) Class III, IV heart failure.\n7. Participants with known chronic obstructive pulmonary disease (COPD) (defined as exertional expiratory volume in 1 second \\[FEV1\\] \\\u003C50% of predicted normal volume), persistent asthma, or a history of asthma within the past 2 years (controlled intermittent asthma or mild persistent asthma is permitted). Participants with known or suspected COPD must have FEV1 testing during screening.\n8. moderate\u002Fsevere renal insufficiency: creatinine clearance \\\u003C 40mL\u002Fmin.\n9. known human immunodeficiency virus (HIV) positivity.\n10. Hepatitis B seropositivity (defined as a positive Hepatitis B surface antigen \\[HBsAg\\] test). Subjects whose infection has resolved (i.e., subjects who are HBsAg negative but positive for Hepatitis B Core Antigen Antibody \\[anti-HBc\\] and\u002For Hepatitis B Surface Antigen Antibody \\[anti-HBs\\]) must be screened for Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) levels using real-time Polymerase Chain Reaction (PCR). PCR-positive subjects will be excluded. Exception:Subjects with serologic results suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.\n11. known or suspected active hepatitis C infection.\n12. any medical or psychiatric condition that, in the opinion of the investigator, may interfere with the completion of treatment under this protocol.\n13. known allergy or intolerance to the test drug.\n14. inability to comply with the protocol\u002Fprocedure.\n15. Subjects will be ineligible to participate in the trial because the genotoxic, mutagenic, and teratogenic effects of the investigational drug(s) involved in this trial on the developing fetus and neonate are unknown if any of the following conditions are present at the time of screening: Pregnant women, lactating mothers, males or females of childbearing potential who refuse adequate contraception (as per protocol).",{"count":183,"type":22},59,[25],"The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \\& consolidation therapy +\u002F- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +\u002F- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)",[29,187,188,141],"High Risk","MRD","2025-06-10",{"date":191,"type":40},"2025-06-12",{"date":193,"type":40},"2024-06-12",{"date":195,"type":22},"2027-12-31",{"name":105,"class":47},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":48},"100558610","phase-2-zanubrutinib-in-combination-with-obinutuzumab-zo-for-newly-diagnosed-follicular-lymphoma-100558610","NCT06553352","Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma","An Open, Single-Arm Clinical Study of Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma (FL)","Inclusion Criteria:\n\n1. Age: ≥18 years old and gender-neutral;\n2. Follicular lymphoma definitively diagnosed according to the REAL\u002FWHO classification, stage II-IV requiring treatment according to the GELF code;\n3. ECOG score 0-2;\n4. Lymphoma efficacy evaluation criteria using Lugano 2014 Lymphoma must have at least one measurable or evaluable lesion: signed informed consent, subjects recruited based on inclusion and exclusion criteria, etc History taking and pre-treatment baseline examination and registration on case report form (CRF) ZO regimen of chemotherapy for 6 cycles, followed by zebrutinib monotherapy orally for 6 months, with observation of toxicities Follow-up assessment (including) Follow-up evaluation (including safety) \\\u003CBlood, biochemistry, B2-MG, neck, chest and abdomen CT plain + enhanced, questionnaire\\> Follow-up evaluation (including safety) \\\u003CBlood, biochemistry, B2-MG, neck, chest and abdomen CT plain + enhanced, questionnaire, once every three months\\> 1. Zerbutinib maintenance treatment for 12 months for PR and above 2. Second-line treatment for the rest of the patients (recommended by NCCN guidelines) NCCN guideline recommendation) Assessment of efficacy i.e. PET\u002FCT with evaluable lesions; CT or MR evaluation of intranodal lesions with a long diameter \\>1.5cm, short diameter \\>1.0cm or extranodal lesions with a long diameter \\>1.0cm;\n5. HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +\u002F-) Enrollment only if HBV-DNA test is negative;\n6. Normal major organ function: liver function serum bilirubin ≤ 2.0 × ULN , serum ALT and AST ≤ 2.5 × ULN, renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma);\n7. Informed consent (patients must sign an informed consent form for all studies).\n\nExclusion Criteria:\n\n1. Medically significant CNS lymphoma or molluscum contagiosum or large cell transformation;\n2. HIV-positive patients and or HCV active infection (documented by HCV-RNA positive test);\n3. Patients should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia Patients should not have transfusion-dependent thrombocytopenia or bleeding disorders Patients should not have autoimmune disorders associated with the study drug;\n4. Known bleeding disorders (e.g., vascular hemophilia or hemophilia) in combination with warfarin or other vitamin K antagonists require treatment with a potent cytochrome P450 (CYP) 3A inhibitor;\n5. Patients with acute coronary syndrome within 6 months prior to study entry must not have had a stroke or intracranial hemorrhage within the past 6 months Prior Surgery: no major surgery within 28 days prior to enrollment or minor surgery within 7 days prior to enrollment; examples of minor surgery include dental procedures, venous access device insertion, skin biopsies, or joint aspirations; procedures may be major or minor at the discretion of the treating physician;\n6. Severe COPD with combined hypoxemia;\n7. Active bacterial, fungal, and, or viral infections not controlled by systemic therapy;\n8. In addition to cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer that does not require systemic therapy, or early breast cancer that requires surgery alone. Other malignant tumors within the last 2 years or concurrently;\n9. Pregnancy and Lactation: Female patients must have a negative serum pregnancy test within 72 hours prior to initiation of regimen therapy and use effective contraception during regimen therapy and for at least 12 weeks after completion of the study.",{"count":205,"type":22},39,[88],"To evaluate the efficacy and side effects of Zanubrutinib combined with Obinutuzumab (ZO) in the treatment of newly diagnosed follicular lymphoma.",[209,29],"Follicular Lymphoma","2024-08-29",{"date":212,"type":40},"2024-09-03",{"date":214,"type":40},"2024-03-31",{"date":216,"type":22},"2027-08-31",{"name":218,"class":47},"The First Affiliated Hospital of Xiamen University",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":225,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":239,"locationsCount":48},"100503333","phase-2-clinical-study-of-xpo1-inhibitor-selinexor-combined-with-copl-in-newly-diagnosed-advanced-nkt-cell-lymphoma-100503333","NCT05833893","Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK\u002FT-cell Lymphoma","Inclusion Criteria:\n\n* Age≥14 years, male or female;\n* Pathologically confirmed newly diagnosed NK\u002FT cell lymphoma according to WHO classification criteria 2016;\n* At least one measurable lesion, defined as bidimensionally measurable, intranodal lesion \\> 1.5 cm in short axis and extranodal lesion \\> 1.0 cm in short axis;\n* ECOG score 0\\~2;\n* Clinical stage III\\~IV;\n* Normal major organ function, meeting the following definitions: Hematology: WBC ≥ 3.5 x 10 9\u002FL, PLT ≥ 75 x 10 9\u002FL, Hb ≥ 80 g\u002FL; Liver and kidney function: AST and ALT ≤ 3.0 ULN; TBIL ≤ 2.0 mg\u002FdL; CCr ≥ 60 mL\u002Fmin; liver and kidney function impairment caused by tumor compression is not limited by this; Fibrinogen: normal at first cycle\n* Expected survival \\> 6 months\n* Agree to use effective contraception;\n* Understand and voluntarily sign written informed consent\n\nExclusion Criteria:\n\n* Prior allogeneic HCT (allo-HCT)\n* Active autoimmune disease\n* Primary central nervous system lymphoma;\n* Patients with infection which requiring treatment. Could be re-enrollment after infection control;\n* Known history of human immunodeficiency virus (HIV) infection\n* Known hypersensitivity to the study drug or any of its excipients;\n* Presence of other active malignancy requiring treatment that could interfere with this study;\n* Patients with other conditions not suitable for enrollment as judged by the investigator.","14 Years",{"count":227,"type":22},10,[88],"Patients with newly diagnosed, pathologically confirmed NK\u002FT-cell lymphoma of stage III-IV treated with XCOPL regimen. 3 weeks for a cycle, with a total of 6-8 cycles.",[231,29,232],"nk\u002FT-cell Lymphoma","Advanced Lymphoma","2023-04-18",{"date":235,"type":40},"2023-04-27",{"date":237,"type":22},"2023-05-01",{"date":44,"type":22},{"name":240,"class":47},"Chinese PLA General Hospital"]