[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemia-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemia-adult":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,66,93,114,136,168,189,205,233,258],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100631050","pediatric-inspired-regimen-combined-with-venetoclax-and-immunotherapy-for-adult-ph-negative-acute-lymphoblastic-leukemia-100631050",false,"NCT07495631","Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia","A Prospective Cohort Study of a Pediatric-Inspired Chemotherapy Regimen Combined With Venetoclax and Immunotherapy for the Treatment of Adult Ph-Negative Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Newly diagnosed, previously untreated (except prednisone\u002Fhydroxyurea) Ph-negative ALL\n* Age ≥14 years, ≤60 years\n* ECOG performance status ≤2\n* Adequate organ function (liver, kidney, cardiac)\n* For patients of childbearing potential: use of effective contraception\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Burkitt leukemia\u002Flymphoma\n* Acute leukemia of ambiguous lineage\n* Pregnancy or lactation\n* Severe uncontrolled active infection\n* History of pancreatitis\n* Uncontrolled diabetes (HbA1c \\>7.5%)\n* Active gastrointestinal bleeding within 6 months\n* Arterial\u002Fvenous thrombosis within 6 months\n* Known HIV positivity\n* Severe psychiatric illness hindering compliance\n* Any other condition deemed unsuitable by the investigator","ALL","14 Years","60 Years",{"count":20,"type":21},43,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.",[27],"Acute Lymphoblastic Leukemia, Adult","RECRUITING","2026-05-10",{"date":31,"type":32},"2026-05-13","ACTUAL",{"date":34,"type":32},"2026-04-08",{"date":36,"type":21},"2030-03-01",{"name":38,"class":39},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100509102","phase-2-car-t-cell-therapy-in-patients-with-renal-dysfunction-100509102","NCT05909059","CAR T-cell Therapy in Patients With Renal Dysfunction","Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction","Inclusion Criteria:\n\n* Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma\n* Adequate bone marrow function to receive lymphodepleting chemotherapy\n* Renal function \\\u003C\u002F= 60mL\u002Fmin\u002F1.73m2\n* ECOG 0-2\n\nExclusion Criteria:\n\n* Relative CNS disorders\n* Active uncontrolled infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator\n* Use of therapeutic dose systemic corticosteroids (defined as \\>20mg\u002Fday prednisone or equivalent) within 72 hours of CAR-T administration","18 Years",{"count":50,"type":21},20,[52],"PHASE2","This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.",[55,56,27],"Non-hodgkin Lymphoma,B Cell","Multiple Myeloma","2026-04-15",{"date":59,"type":32},"2026-04-20",{"date":61,"type":32},"2024-11-18",{"date":63,"type":21},"2027-08-31",{"name":65,"class":39},"Northside Hospital, Inc.",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":40},"100553064","efficacy-and-safety-of-tki-combined-with-chemotherapy-and-sequential-car-t-cells-in-nd-adult-patients-with-ph-all-100553064","NCT06481228","Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL","Efficacy and Safety of Molecular Targeted Therapy Combined With Chemotherapy and Sequential CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Positive B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Male or female patients aged 18 years or older\n2. Newly diagnosed Philadelphia chromosome positive(either t(9;22) and\u002For BCR-ABL positive and\u002F or FISH positive) acute lymphoblastic leukemia\n3. CD19 expression on blasts\n4. Expected survival time greater than 3 months\n5. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%\n6. Subject has provided written informed consent prior to any screening procedure\n\nExclusion Criteria:\n\n1. Lymphoid blast crisis of chronic myelocytic leukemia (CML)\n2. Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and\u002For radiotherapy, except for appropriate pre-treatment)\n3. Patients with a history of myocardial infarction within 12 months or clinically significant cardiac disorders disease (e.g., unstable angina, congestive heart failure, uncontrollable hypertension, uncontrollable arrhythmia, etc.)\n4. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment\n5. Known HIV seropositivity\n6. History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis\n7. Uncontrolled hypertriglyceridemia (triglycerides \\>450 mg\u002FdL)\n8. Another malignancy diagnosed and treated within 5 years prior to diagnosis or previously diagnosed with another malignancy with evidence of residual disease. Patients with non-melanoma skin cancer or any type of carcinoma in situ that has been completely excised should not be excluded\n9. Female patients who are pregnant or breast feeding\n10. Clinical manifestations of active CNS or extramedullary involvement with ALL\n11. Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \\>7.5%. Patients with preexisting, well-controlled diabetes are not excluded\n12. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment\n13. Other conditions assessed by the investigators to be inappropriate for this study",{"count":74,"type":21},82,[24],"In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed\u002Frefractory (R\u002FR）B-ALL. The available data suggest that the advancement of immunotherapy from R\u002FR field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph+ ALL patients achieving complete remission (CR) with overembatinib, venetoclax and reduced-intensity chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.The study endpoints include 2-year disease-free survival (DFS) rate, overall survival (OS) rate, event-free survival (EFS) rate, cumulative molecular remission rate, immune repertoire-minimal residual disease (MRD) remission rate, cumulative relapse rate, treatment-related toxicities, and quality of life. Additionally, an interim analysis will be conducted, with the 1-year DFS rate as the key index for this analysis.",[78,27],"Philadelphia Positive Acute Lymphoblastic Leukemia",[80,81,82,83,84],"Ph-Positive Acute Lymphoblastic Leukemia","CAR-T cell","Venetoclax","olverembatinib","Newly Diagnosed","2026-02-26",{"date":87,"type":32},"2026-03-02",{"date":89,"type":32},"2024-06-04",{"date":91,"type":21},"2028-06-01",{"name":38,"class":39},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":40},"100553065","efficacy-and-safety-of-chemotherapy-combined-with-car-t-cells-in-newly-diagnosed-adult-patients-with-ph--b-all-100553065","NCT06481241","Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL","Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. De novo and primary Ph\u002FBCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification\n2. Male or female patients aged 18 years or older\n3. CD19 expression on blasts\n4. Expected survival time greater than 3 months\n5. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%\n6. Subject has provided written informed consent prior to any screening procedure\n\nExclusion Criteria:\n\n1. Burkitt lymphoma\u002Fleukemia\n2. Acute Leukemia of Ambiguous Lineage\n3. Clinical manifestations of active CNS or extramedullary involvement with ALL\n4. Female patients who are pregnant or breast feeding\n5. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment\n6. Known HIV seropositivity\n7. Clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal) or sinus block, history of chronic bradycardia with a high degree of atrioventricular (AV) conduction block (unless a permanent pacemaker is implanted)\n8. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment\n9. Other conditions assessed by the investigators to be inappropriate for this study",{"count":101,"type":21},77,[24],"In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed\u002Frefractory (R\u002FR）B-ALL. The available data suggest that the advancement of immunotherapy from relapsed\u002Frefractory (R\u002FR) field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph- B-ALL patients achieving complete remission (CR) with chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.The study endpoints include 2-year disease-free survival (DFS) rate, overall survival (OS) rate, event-free survival (EFS) rate, cumulative molecular remission rate, immune repertoire-minimal residual disease (MRD) remission rate, cumulative relapse rate, treatment-related toxicities, and quality of life. Additionally, an interim analysis will be conducted, with the 1-year DFS rate as the key index for this analysis.",[105,27],"Philadelphia Chromosome Negative ALL",[107,81,82,84],"Philadelphia Chromosome Negative Precursor B-Cell Acute Lymphoblastic Leukaemia",{"date":87,"type":32},{"date":110,"type":32},"2024-06-10",{"date":112,"type":21},"2028-06",{"name":38,"class":39},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":18,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":40},"100597489","phase-2-multicenter-study-of-combined-chemotherapy-and-transplantation-for-adult-all-100597489","NCT07059156","Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL","Multicenter Study on Integrated Treatment Regimen of Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age: 18 to 60 years；\n2. Diagnosis must comply with the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2024 Edition), requiring MICM (Morphology, Immunology, Cytogenetics, and Molecular genetics) integration and WHO 2022 (5th edition) classification standards. The minimal diagnostic workup must include morphological assessment and immunophenotyping to differentiate ALL from acute myeloid leukemia (AML). All patients shall undergo bone marrow aspiration plus biopsy at initial diagnosis. A definitive ALL diagnosis requires ≥20% blasts\u002Fimmature lymphocytes in bone marrow (Note: Patients with \\\u003C20% blasts due to fever or glucocorticoid pretreatment require comprehensive evaluation incorporating medical history and ancillary tests for differential diagnosis)；\n3. ECOG Performance Status: 0-2\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage\n2. Pregnancy\n3. Psychiatric disorders or other conditions compromising protocol compliance\n4. Severe cardiac arrhythmia with ECG abnormalities (QTc \\>500 ms)",{"count":122,"type":21},50,[52,124],"PHASE3","This study aims to evaluate an integrated treatment protocol for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), combining induction chemotherapy, consolidation therapy, and allogeneic hematopoietic stem cell transplantation (allo-HSCT) to improve treatment efficacy and survival rates. The single-arm, open-label, multicenter study will enroll 50 newly diagnosed patients aged 18-60 years. The induction phase employs the VICP+VEN regimen (vindesine, idarubicin, cyclophosphamide, prednisone combined with venetoclax), followed by consolidation therapy with either Hyper-CVAD or CAM protocols, with eligible patients proceeding to allo-HSCT. Primary endpoints include disease-free survival (DFS) and complete remission (CR) rates, while secondary endpoints encompass relapse rate, overall survival (OS), and safety. Patients will be followed for 2 years with regular monitoring of minimal residual disease (MRD) and adverse events. The protocol is designed to reduce relapse risk through intensive therapy and transplantation, offering a potential cure for high-risk patients.The goal is to complete the entire treatment within 4 months after diagnosis.",[27],"2025-07-01",{"date":129,"type":32},"2025-07-10",{"date":131,"type":32},"2025-06-01",{"date":133,"type":21},"2027-07",{"name":135,"class":39},"Shanxi Bethune Hospital",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":40},"100520762","phase-1-thiotepa-cyclophosphamide-clarithromycin-and-cytarabine-100520762","NCT06060782","Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine","Clinical Study on the Efficacy and Safety of Auto-HSCT in Adult Patients with Burkitt Lymphoma, Lymphoblastic Lymphoma, and Acute Lymphoblastic Leukemia Who Received TCCA Conditioning Regimen","TCCA","Inclusion Criteria:\n\n* 1\\. Voluntarily sign the informed consent form, which must be signed by the patient himself.\n\n  2\\. ALL patients confirmed by bone marrow cell morphology, immunology, and genetics; 3. PH+ALL patients who achieve s3CMR (definition: achieve molecular biological remission in the early stage of initial treatment (within 3 months) and maintain remission); 4. Ph-B-ALL patients who have reached MRD- after 3 courses of chemotherapy and continue to be MRD-; adult patients with Burkitt lymphoma and lymphoblastic lymphoma confirmed by histopathology and molecular genetics; 5. Adult patients with Burkitt lymphoma and lymphoblastoma, if the bone marrow is not involved, can achieve PR or above after induction; if the bone marrow is involved at the time of initial diagnosis, 3 courses of chemotherapy are required to reach MRD- and continue to be MRD-.\n\n  6\\. Patients receiving autologous hematopoietic stem cell transplantation (auto-HSCT); 7. Age ≥18 years and ≤65 years old, male or female; 8. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2;\n\nExclusion Criteria:\n\n* 1\\. Have a history of cancer and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN), or prostate epithelium Internal carcinogenesis (PIN); 2. Known to be serologically positive for HIV, active hepatitis B, active hepatitis C virus or syphilis; 3. Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring; 4. Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment; 5. Received hematopoietic stem cell transplantation within the past 1 year; 6. Active heart disease, defined as one or more of the following:\n\n  1. Have a history of uncontrolled or symptomatic angina;\n  2. Myocardial infarction less than 6 months from study enrollment;\n  3. Have a history of arrhythmia that requires drug treatment or has severe clinical symptoms;\n  4. Uncontrolled or symptomatic congestive heart failure (\\>NYHA class 2);\n  5. The ejection fraction is lower than the lower limit of the normal range. 7. Patients who meet the following criteria:\n\n  \u003C!-- -->\n\n  1. Major surgery (except diagnostic surgery) is planned within 4 weeks before enrollment or during the study period, or the surgical wound has not fully healed before enrollment;\n  2. Those who have received (attenuated) live vaccines within 4 weeks before enrollment;\n  3. Patients with suspected active or latent tuberculosis;\n  4. Participate in other clinical trials one month before enrollment 8. Those who the researcher believes are not suitable for enrollment","65 Years",{"count":146,"type":21},28,[148],"PHASE1","This study is an observational study on the efficacy and safety of auto-HSCT in adult patients with Burkitt lymphoma, lymphoblastic lymphoma, and acute lymphoblastic leukemia who received TCCA conditioning regimen. The study plans to include 28 patients who received the TCCA regimen for pre-transplantation pretreatment before auto-HSCT. Maintenance treatment will be carried out after transplantation for 1 year to observe the efficacy and safety.",[151,152,27],"Burkitt Lymphoma","Lymphoblastic Lymphoma, Adult",[154,155,156,157,158],"Thiotepa","Cyclophosphamide","Cladribine","Cytarabine","conditioning regimen","2025-03-04",{"date":161,"type":32},"2025-03-06",{"date":163,"type":32},"2024-03-06",{"date":165,"type":21},"2026-12-31",{"name":167,"class":39},"Fifth Affiliated Hospital, Sun Yat-Sen University",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":144,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":40},"100558902","phase-2-a-prospective-open-label-randomized-controlled-multicenter-clinical-study-of-msd-hsct-using-a-tbi-or-tmli-conditioning-regimen-for-adult-all-100558902","NCT06557161","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Matched Sibling Donor Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Adult Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Informed Consent: Participants must voluntarily sign a written informed consent form.\n2. Age and Gender: Participants should be male or female, aged 18-65 years, inclusive.\n3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to adults aged 18-65 years.\n4. Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.\n5. Donor Availability: There must be a suitable mathced sibling donor available, and the participant must consent to undergo MSD hematopoietic stem cell transplantation (MSD-HSCT).\n6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, indicating that they are capable of caring for themselves and carrying out normal activities. Additionally, they must not have significant organ dysfunction, defined by the following:\n\n   * Cardiac Function: New York Heart Association (NYHA) classification of class II or lower.\n   * Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be no more than 2.5 times the upper limit of normal. Bilirubin levels should be no more than 2 times the upper limit of normal.\n   * Renal Function: Serum creatinine levels should be no more than 1.5 times the upper limit of normal, or the creatinine clearance rate should be at least 60 ml\u002Fmin.\n   * Pulmonary Function: Participants should not experience significant dyspnea, should not require oxygen therapy, should not have interstitial lung disease, and should not have any active pulmonary infections.\n7. Reproductive Health:\n\n   * Women of childbearing potential must test negative for pregnancy with a Human Chorionic Gonadotropin (HCG) test, confirmed by immunofluorescence during both screening and baseline periods. They must also agree to use effective contraception for at least one year following the transplantation.\n   * Male participants with female partners of childbearing potential must agree to use effective barrier contraception and refrain from sperm donation for at least one year following the transplantation.\n\nExclusion Criteria: To be eligible for inclusion in the study, participants must not meet any of the following criteria:\n\n1. The patient has not achieved hematologic remission before transplantation.\n2. The patient has chosen a non-MSD donor.\n3. The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.\n4. The patient has an active or refractory infection, or other life-threatening complications.\n5. The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.\n6. The patient refuses to sign the informed consent form, is unwilling to comply with clinical follow-up required by the study, or does not consent to the use of their data to support future research, project presentations, and clinical practices.\n7. The investigator deems the patient unsuitable for participation in the study for any other reason.",{"count":176,"type":21},170,[52],"This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in adult ALL patients, with the goal of improving patient quality of life and survival outcomes.",[27],"2025-02-16",{"date":182,"type":32},"2025-02-18",{"date":184,"type":21},"2025-03-01",{"date":186,"type":21},"2029-12-31",{"name":188,"class":39},"The First Affiliated Hospital of Zhengzhou University",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":144,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":203,"leadSponsor":204,"locationsCount":40},"100559470","phase-2-a-prospective-open-label-randomized-controlled-multicenter-clinical-study-of-haplo-hsct-using-a-tbi-or-tmli-conditioning-regimen-for-adult-all-100559470","NCT06564545","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haploidentical Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Adult Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Informed Consent: Participants must voluntarily sign a written informed consent form.\n2. Age and Gender: Participants should be male or female, aged 18-65 years, inclusive.\n3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to adults aged 18-65 years.\n4. Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.\n5. Donor Availability: There must be a suitable haploidentical donor available, and the participant must consent to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).\n6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, indicating that they are capable of caring for themselves and carrying out normal activities. Additionally, they must not have significant organ dysfunction, defined by the following:\n\n   * Cardiac Function: New York Heart Association (NYHA) classification of class II or lower.\n   * Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be no more than 2.5 times the upper limit of normal. Bilirubin levels should be no more than 2 times the upper limit of normal.\n   * Renal Function: Serum creatinine levels should be no more than 1.5 times the upper limit of normal, or the creatinine clearance rate should be at least 60 ml\u002Fmin.\n   * Pulmonary Function: Participants should not experience significant dyspnea, should not require oxygen therapy, should not have interstitial lung disease, and should not have any active pulmonary infections.\n7. Reproductive Health:\n\n   * Women of childbearing potential must test negative for pregnancy with a Human Chorionic Gonadotropin (HCG) test, confirmed by immunofluorescence during both screening and baseline periods. They must also agree to use effective contraception for at least one year following the transplantation.\n   * Male participants with female partners of childbearing potential must agree to use effective barrier contraception and refrain from sperm donation for at least one year following the transplantation.\n\nExclusion Criteria:\n\nTo be eligible for inclusion in the study, participants must not meet any of the following criteria:\n\n1. The patient has not achieved hematologic remission before transplantation.\n2. The patient has chosen a non-haploidentical related donor.\n3. The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.\n4. The patient has an active or refractory infection, or other life-threatening complications.\n5. The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.\n6. The patient refuses to sign the informed consent form, is unwilling to comply with clinical follow-up required by the study, or does not consent to the use of their data to support future research, project presentations, and clinical practices.\n7. The investigator deems the patient unsuitable for participation in the study for any other reason.",{"count":197,"type":21},276,[52],"This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for haplo-HSCT in adult ALL patients, with the goal of improving patient quality of life and survival outcomes.",[27],{"date":182,"type":32},{"date":184,"type":21},{"date":186,"type":21},{"name":188,"class":39},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":212,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100337673","phase-1-treatment-of-patients-with-relapsed-or-refractory-cd19-lymphoid-disease-with-t-cells-expressing-a-third-generation-car-100337673","NCT03676504","Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR","Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I\u002FII Clinical Trial","Inclusion Criteria:\n\nStratum I\u002FII (Adults):\n\n* Confirmed CD19+ ALL, CLL, DLBCL, FL or MCL in patients ≥ 18 years\n* ALL (Ph+ and Ph-): Confirmed CD19+ ALL by cytology and flow cytometry (FACS) AND\n* Relapsed or refractory disease (including \"molecular relapse\" with minimal residual disease (MRD) levels \\> 10\\^-3 at two occasions \\> 2 weeks apart) with confirmed CD19 expression on malignant cells in relapse\n\n  * Any relapse after allogeneic stem cell transplantation (alloSCT) (≥ 6 months from alloSCT at time of CAR T cell infusion) OR\n  * Any relapse failing to achieve an MRD level of \\\u003C 10\\^-3 after ≥ 2 lines of treatment OR\n  * Primary refractory as defined by not achieving a complete remission (CR) after ≥ 2 lines of treatment\n* CLL\u002FNHL: Confirmed CD19+ CLL\u002FNHL (including CLL, DLBCL, FL or MCL) with\n\n  * CLL in need of treatment with:\n\n    1. Early relapse (within 2 years) after end of chemoimmunotherapy or chemoimmunotherapy refractoriness plus failure or intolerance of both Bruton's tyrosine kinase Inhibitor (BTKi) and B-cell lymphoma 2 inhibitors (BCL-2i) OR\n    2. Relapse after alloSCT, ineligible for or refractory to standard interventions (donor lymphocyte infusions (DLI), CD20 antibodies, chemoimmunotherapy)\n  * DLBCL with:\n\n    1. Refractoriness to a 2nd or later line of chemoimmunotherapy OR\n    2. Relapse after autologous stem cell transplantation (autoSCT) plus ineligibility for alloSCT (including refractoriness to one line of salvage chemoimmunotherapy) OR\n    3. Relapse after alloSCT\n  * FL in need of treatment with:\n\n    1. Relapse \\\u003C2 years after chemoimmunotherapy AND ineligibility for or failure of autologous stem cell transplantation (autoSCT) AND ineligibility for or failure of idelalisib OR\n    2. Relapse after alloSCT, ineligible for or refractory to standard interventions (DLI, CD20 antibodies, chemoimmunotherapy)\n  * MCL with:\n\n    1. Relapse after standard first-line therapy AND ineligibility for or failure to BTKi salvage therapy OR\n    2. Relapse after alloSCT AND ineligibility for or failure to BTKi salvage therapy\n* Measurable disease\u002FMRD at time of enrollment\n* Life expectancy ≥ 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at the time of screening\n* Adequate organ function:\n\n  * Renal function defined as: serum creatinine of ≤ 2 x ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m\\^2\n  * Liver function defined as:\n  * ALT ≤ 5 times the ULN for the respective age\n  * Bilirubin ≤ 2.0 mg\u002Fdl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome (may be included if total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) or extrahepatic disease (e.g. chronic hemolytic anemia)\n  * minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \\> 90% on room air\n  * Hemodynamic stability and left ventricular ejection fraction (LVEF) ≥ 40% as confirmed by echocardiogram\n  * Absolute neutrophil count (ANC) ≥ 500\u002Fmm3\n  * Absolute lymphocyte count (ALC) ≥ 100\u002Fmm3\n* Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for one year following CD19.CAR T cell therapy\n* Ability to understand the nature of the trial and the trial related procedures\n* Written informed consent must be obtained prior to any screening procedures\n\nStratum III (Children and Adolescents with ALL):\n\n* Age of \\> 3 years until \\\u003C 18 years at the time of screening\n* CD19+ ALL (Ph+ and Ph-) confirmed by cytology and flow cytometry (FACS) AND\n* Relapsed or refractory disease (including \"molecular relapse\" with polymerase chain reaction (PCR) MRD \\> 10\\^-3 at two occasions \\> 2 weeks apart) with confirmed CD19 expression on malignant cells in relapse\n\n  * Any relapse after alloSCT (≥ 6 months from alloSCT at time of CAR T cell infusion) OR\n  * Any relapse failing to achieve an MRD level of \\\u003C 10\\^-3 after ≥ 2 lines of treatment OR\n  * Primary refractory as defined by not achieving a CR after ≥ 2 lines of treatment\n* Measurable disease\u002FMRD at time of enrollment\n* Life expectancy ≥ 12 weeks\n* ECOG performance status ≤ 2 (age ≥ 16 years) or Lansky performance status ≥ 50 (age \\\u003C 16 years) at the time of screening\n* Adequate organ function:\n\n  * Renal function defined as serum creatinine-clearance ≥ 30 mL\u002Fmin\u002F1.73 m\\^2\n  * Liver function defined as:\n  * ALT ≤ 5 times the ULN for the respective age\n  * Bilirubin ≤ 2.0 mg\u002Fdl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome or extrahepatic disease (e.g. chronic hemolytic anemia)\n  * minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \\> 90% on room air\n  * Hemodynamic stability and LVEF ≥ 40% or shortening fraction \\> 29% as confirmed by echocardiogram\n  * ANC) ≥ 500\u002Fmm3\n  * ALC ≥ 100\u002Fmm3\n* Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and postpubertal male participants must agree to use highly effective methods of contraception for one year following CD19.CAR T cell therapy\n* Written informed consent of the study patient and\u002For the legal representative must be obtained prior to any screening procedures\n\nExclusion Criteria:\n\nStratum I\u002FII (Adults):\n\n* The following medications are excluded:\n\n  * Immunosuppressive medication with the exception of ≤ 30 mg prednisolone\u002Fd or equivalent at the time of CAR T cell transfusion\n  * Bridging\u002Fmaintenance therapy including chemo- and immunotherapy must be stopped ≥ 2 weeks prior to leukapheresis, but can be continued between leukapheresis and lymphodepletion\n* Intrathecal chemotherapy is possible at any time, but not during lymphodepletion until 14 days after CD19.CAR T cell transfusion\n* Any DLI must be completed \\> 6 weeks prior to CD19.CAR T cell infusion\n* Florid\u002Facute or chronic Graft-versus-Host disease (GvHD)\n* Uncontrolled active hepatitis B or C\n* HIV-positivity\n* Uncontrolled acute life-threatening bacterial, viral or fungal infection\n* Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure New York Heart Association (NYHA) III-IV, uncontrolled diabetes mellitus, uncontrolled hyperlipidemia)\n* Unstable angina and\u002For myocardial infarction within 3 months prior to screening\n* Any previous or concurrent malignancy.\n\nThe following exceptions do NOT constitute exclusion criteria:\n\n* Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)\n* In situ carcinoma of the cervix or breast, treated curatively without evidence of recurrence ≥ 3 years prior to the study\n* CLL or FL transformed into an aggressive B cell lymphoma\n* A primary malignancy which is in complete remission for ≥ 5 years\n\n  * Pregnant or nursing (lactating) women\n  * Intolerance to the excipients of the cell product\n  * Active central nervous System (CNS) involvement in ALL patient at the time of screening is not an exclusion criterion, but patients with CNS 3 status at clinical screening (d-14) are not eligible for CD19.CAR T cell transfusion\n  * Participation in another clinical trial at the time of screening\n\nStratum III (Children and Adolescents with ALL):\n\n* The following medications are excluded:\n\n  * immunosuppressive medication with the exception of \\\u003C 0.5 mg\u002Fd\\*kg body weight (BW) prednisolone-equivalent at the time of CD19.CAR T cell transfusion\n  * Bridging\u002FMaintenance therapy including chemo- and immunotherapy must be stopped ≥ 2 weeks prior to leukapheresis, but can be continued between leukapheresis and lymphodepletion\n* Intrathecal chemotherapy is possible at any time, but not during lymphodepletion until 14 days after CD19.CAR T cell transfusion\n* Any DLI must be completed \\> 6 weeks prior to CD19.CAR T cell infusion\n* Florid\u002Facute or chronic GvHD\n* Uncontrolled active hepatitis B or C\n* HIV-positivity\n* Uncontrolled acute life-threatening bacterial, viral or fungal infection\n* Severe concomitant disease (e.g. any life-limiting genetic disorder). Patients with Down Syndrome will not be excluded.\n* Any previous or concurrent malignancy.\n\nThe following exceptions do not constitute exclusion criteria:\n\n* Lymphoblastic lymphoma transformed into a CD19+ acute lymphoblastic leukemia\n* A primary malignancy which is in complete remission for ≥ 5 years\n\n  * Pregnant or nursing (lactating) women\n  * Intolerance to the excipients of the cell product\n  * Active CNS involvement at the time of screening is not an exclusion criterion, but patients with CNS 3 status at clinical screening (d-14) are not eligible for CD19.CAR T cell transfusion\n  * Participation in another clinical trial at the time of screening","3 Years",{"count":214,"type":21},68,[148,52],"Adult patients with r\u002Fr acute lymphoblastic leukemia (ALL) (stratum I), r\u002Fr Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r\u002Fr ALL (stratum III) will be treated with autologous T-lymphocytes transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (0,1-20×20\\^7 transduced cells\u002Fm\\^2) after lymphodepletion with fludarabine and cyclophosphamide.",[27,218,219,220,221,222],"Acute Lymphoblastic Leukemia, Pediatric","Chronic Lymphocytic Leukemia","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Mantle Cell Lymphoma","2024-07-26",{"date":225,"type":32},"2024-07-29",{"date":227,"type":32},"2018-09-07",{"date":229,"type":21},"2027-12-31",{"name":231,"class":39},"University Hospital Heidelberg",2,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":40},"100531928","phase-1-tgrx-814-chinese-phase-iii-in-patients-with-hematological-malignancies-100531928","NCT06206174","TGRX-814 Chinese Phase I\u002FII in Patients With Hematological Malignancies","A Single-arm, Open-label, Dose Escalation and Expansion Phase I\u002FII Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-814 Monotherapy and Combination Therapy in Patients With Hematological Malignancies","Inclusion Criteria:\n\n1. male or female ≥ 18 years of age\n2. fully understand the requirements of the study and voluntarily sign a written informed consent form\n3. diagnosis of NHL, ALL, AML or MDS\n4. Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2\n5. adequate bone marrow function\n6. patients at high risk for Tumor Lysis Syndrome (TLS) determined by investigator and sponsor for agreement to enroll\n7. adequate disease indicator\n8. adequate coagulation, hepatic and renal function\n9. female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use a medically approved highly effective contraceptive from the time of signing the Informed Consent Form until at least 3 months after the last dose of study drug; women of childbearing potential must have a negative blood or urine pregnancy test within 7 days prior to the first dose of study drug\n10. Expected survival time ≥ 12 weeks\n\nExclusion Criteria:\n\n1. received BCL-2 inhibitor therapy prior to the first dose of study drug, unless discontinued due to intolerance\n2. subjects with NHL have been diagnosed with Burkitt's lymphoma, lymphoblastoid lymphoma\u002Fleukemia, or post-transplant lymphoproliferative disease (PTLD)\n3. AML subjects with a diagnosis of acute promyelocytic leukemia or Ph chromosome positive or persistent extramedullary leukemia\n4. tumor infiltration of the central nervous system\n5. received allogeneic hematopoietic stem cell transplantation; or received autologous hematopoietic stem cell transplantation within 3 months\n6. received vaccination within 4 weeks prior to first dose or scheduled to be vaccinated during the study\n7. HBsAg-positive or HBcAb-positive; HCV antibody-positive; HIV antibody-positive\n8. monoclonal antibody antitumor therapy within 4 weeks prior to the first dose; participation in a clinical trial of another interventional drug within 4 weeks prior to the first dose; participation in CAR-T therapy within 12 weeks prior to the first dose; 9. 14 weeks prior to the first dose\n9. received anticancer therapy\u002Finvestigational therapy within 14 days prior to the first dose, or has not recovered from clinically significant toxicity below grade 2 on prior therapy\n10. received steroidal anticancer therapy, CYP3A inhibitors, or CYP3A inducers within 7 days prior to the first dose of study drug\n11. consumption of grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or popcorn within 3 days prior to the first dose of the drug\n12. poorly controlled hypertension; left ventricular ejection fraction ≤ 50% as assessed by cardiac ultrasound; prolonged QT interval; Grade III atrioventricular block or other arrhythmia requiring medical intervention; New York Heart Association (NYHA) Class III or IV congestive heart failure; had myocardial infarction or experienced bypass surgery within 6 months prior to dosing; had arterial or venous thrombotic events within 6 months prior to the first dose of study drug; have other cardiovascular diseases that investigator deemed unfit for enrollment\n13. having a history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the Investigator, would adversely affect the subject's participation in this study\n14. having a history of active malignancy other than NHL, AML, or MDS within 3 years prior to participation in this clinical study\n15. having a condition of malabsorption syndrome or multiple factors that interfere with the oral administration and absorption of medication\n16. other uncontrolled conditions of clinical significance\n17. other factors that, in the opinion of the Investigator, may affect the results of the study and interfere with the patient's participation in the study, including previous or existing medical conditions, abnormalities in treatment or laboratory tests, unwillingness of the subject to comply with the procedures, restrictions and requirements of the study, and other conditions that make enrollment in the study unsuitable.",{"count":241,"type":21},30,[148,52],"The purpose of this single- arm, open-label, dose escalation and dose expansion phase I\u002FII study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-814 in patients with hematological malignancies including non-Hodgkin lymphoma, acute myeloid leukemia, aute lymphoblastic leukemia and myelodysplastic syndromes.",[245,246,247,27,248],"Hematologic Malignancy","Non Hodgkin Lymphoma","Acute Myeloid Leukemia","Myelodysplastic Syndromes","2024-04-09",{"date":251,"type":32},"2024-04-10",{"date":163,"type":32},{"date":254,"type":21},"2029-02-28",{"name":256,"class":257},"Shenzhen TargetRx Co., Ltd.","INDUSTRY",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":265,"enrollmentInfo":266,"targetDuration":268,"studyType":269,"phases":4,"briefSummary":270,"conditions":271,"keywords":272,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":232},"100449028","rwe-of-pediatric-like-protocol-for-aya-patients-with-ph-negative-all-100449028","NCT05127148","RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL","Real-world Evidence of First-line Treatment With Pediatric-like Protocol for Adolescents and Young Adults Patients Diagnosed With Philadelphia-negative Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Signature of the form consent for participation in the study\n* Ph-negative ALL diagnosis without previous treatment.\n\nExclusion Criteria:\n\n* ALL with mature B phenotype (sIg +) or with the cytogenetic alterations characteristic of ALL mature B (t (8,14), t (2, 8), t (8, 22)).\n* Ph-positive ALL\n* Acute leukemias of ambiguous lineage (undifferentiated or mixed phenotype).\n* Patients with a history of coronary, valvular or hypertensive heart disease, that contraindicate the use of anthracyclines.\n* Patients with chronic liver disease in the activity phase and \u002F or Bilirubin\\> 2 mg \u002F dl and \u002F or transaminases 5 times the normal limit, not related to ALL.\n* Patients with severe chronic respiratory failure.\n* Renal failure and \u002F or creatininemia\\> 2 mg \u002F dl not related to ALL.\n* Serious neurological disorders, not related to leukemic disease.\n* General condition affected (grades 3 and 4), not attributable to ALL.\n* Uncontrolled infection by HIV, HTLV-1, HBV, HCV.\n* Patient not a candidate for treatment based on the criteria of the treating physician.\n* Pregnant women will have to be evaluated by a multidisciplinary team and an ethics committee.","40 Years",{"count":267,"type":21},100,"60 Months","OBSERVATIONAL","This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of adolescent and young patients with ph-negative acute lymphoblastic leukemia with first-line pediatric-like protocol in Argentina.",[27],[273],"Acute Lymphoblastic Leukemia","2024-01-08",{"date":276,"type":32},"2024-01-09",{"date":278,"type":32},"2021-03-01",{"date":280,"type":21},"2026-12-01",{"name":282,"class":39},"Grupo Argentino de Tratamiento de la Leucemia Aguda"]