[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"precursor-b-cell-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:precursor-b-cell-acute-lymphoblastic-leukemia":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,69],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100648552","phase-3-a-study-of-injectable-blb101-and-blincyto-in-adult-participants-with-rr-cd19-b-all-100648552",false,"NCT07723911","A Study of Injectable BLB101 and Blincyto® in Adult Participants With R\u002FR CD19+ B-ALL","A Randomized, Double-Blind, Positive-Controlled, Multicenter Clinical Study to Compare the Similarities in Pharmacokinetics, Efficacy, Safety and Immunogenicity Between BLB101 and Blincyto® in Adult Participants With R\u002FR CD19+ B-ALL","Inclusion Criteria:\n\nParticipants must meet all of the following inclusion criteria to be included in this study:\n\n1. Before the trial began, the trial details were known, and the participant understood and voluntarily signed the Informed Consent Form (ICF);\n2. Age ≥ 18 years old;\n3. Confirmed as Philadelphia chromosome (Ph) negative and CD19 positive relapsed\u002Frefractory B-ALL (must meet: ① Through morphological and local flow cytometry immunophenotype assessment, there are expressed CD19 primitive immature cells in peripheral blood or bone marrow, confirming the current state of relapse, and there are relevant medical records to support; ② The proportion of primitive cells in the bone marrow is greater than 5% (measured by morphology); ③ Chromosome karyotype analysis or FISH analysis or PCR or NGS confirms Ph-negative), the Ph status needs to be reconfirmed before enrollment;\n4. ECOG ≤ 2 points;\n5. The number of previous treatment lines is 1 to 2, and it meets the definition of relapse or refractory (any of the following conditions can be included in the group: ① Late relapse: Reversal after achieving remission with previous treatment and duration ≥ 12 months; ② Early relapse: Remission achieved with previous treatment and duration \\\u003C 12 months; ③ Refractory: Failure to achieve remission during the first induction or salvage treatment; ④ Recurrence after transplantation: Recurrence at any time after hematopoietic stem cell transplantation);\n6. Weight ≥ 45 kg;\n7. Expected survival period ≥ 3 months;\n8. Organ function requirements: Liver and kidney function: ALT\u002FAST ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN; Creatinine clearance rate ≥ 60 mL\u002Fmin; Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, no severe arrhythmia;\n9. Participants need to have recovered to ≤ Grade 1 toxicity from previous treatments (according to CTCAE V6.0 standards), excluding hematological toxicity;\n10. Participants need to meet the washout period from the first administration of anti-tumor treatment: a) At least 2 weeks after the end of cytotoxic chemotherapy drugs treatment; b) At least 5 half-lives after non-cytotoxic drugs (if the duration of 5 half-lives exceeds 4 weeks, the washout period is still counted as 4 weeks), for drugs with an unclear half-life, it is counted as more than 4 weeks; c) At least 2 weeks after anti-tumor traditional Chinese medicine treatment; d) At least 3 months after CAR-T treatment; e) At least 5 half-lives after antibody drugs and antibody conjugate drugs (ADC); (if the duration of 5 half-lives exceeds 3 months, the washout period is still counted as 3 months);\n11. According to the investigator's judgment, the participant's compliance can reach understanding and following the plan for visits, treatment, laboratory tests, and other research procedures, and is expected to receive the study drug for ≥ 1 cycle;\n12. For female participants with reproductive capacity: Agree to take effective contraceptive measures from the start of signing the informed consent form until 6 months after the last administration of the trial drug, and agree not to donate eggs. For male participants: Agree to take effective contraceptive measures from the start of signing the informed consent form until 6 months after the last administration of the trial drug, and agree not to donate sperm. -\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria are not eligible to be included in this study:\n\n1. Participants with negative CD19 in ALL;\n2. Participants with Ph-positive ALL or mixed phenotype;\n3. Pregnant or lactating women;\n4. Active central nervous system (CNS) leukemia (cerebrospinal fluid white blood cells ≥ 5\u002FμL and leukemia cells are observed); those with a history of CNS disease who have received effective treatment and achieved remission are excluded;\n5. Participants with Burkitt lymphoma\u002Fleukemia;\n6. Participants with isolated extramedullary disease recurrence and active ALL in the testicles;\n7. Participants who have received targeted CD19 anti-tumor therapy before and have a proportion of CD19-positive leukemia cells \\\u003C 50%;\n8. Participants who have received at least 28 days of targeted CD19 bispecific antibody treatment and have been ineffective (ineffectiveness is defined as the failure to achieve CR or CRh or CRi or MLFS in the efficacy evaluation);\n9. Participants who have received at least 1 time of targeted CD19 CAR-T infusion and have been ineffective (ineffectiveness is defined as the failure to achieve CR or CRh or CRi or MLFS in the efficacy evaluation);\n10. Participants who have received targeted CD19 bispecific antibody treatment and have achieved CR or CRh or CRi or MLFS but have relapsed within ≤ 6 months;\n11. Participants who have received targeted CD19 CAR-T treatment and have achieved CR or CRh or CRi or MLFS but have relapsed within ≤ 12 months;\n12. Participants who have received autologous HSCT within 6 weeks before the first administration or have received allogeneic HSCT within 3 months before the first administration;\n13. Any active acute graft-versus-host disease (GvHD) grade 2-4 (according to the Glucksberg standard), or active chronic GvHD requiring systemic treatment;\n14. Any systemic treatment for GVHD within 2 weeks before the first administration;\n15. Participants with positive HIV antibody; participants with active HBV infection: positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA above the upper limit of normal; positive for HCV antibody and positive for HCV RNA in peripheral blood;\n16. Participants have active infections (including bacterial, viral, and fungal infections) that require systemic intravenous antibiotics treatment as judged by the investigator to have clinical significance;\n17. Participants with significant active cardiovascular disease within the past 6 months, including but not limited to the following conditions: ≥ III grade heart failure according to the New York Heart Association (NYHA) definition; angina pectoris, unstable angina pectoris, myocardial infarction requiring surgical treatment; uncontrolled hypertension (i.e., systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 90 mmHg) after treatment; arrhythmia not controlled; echocardiography-measured resting left ventricular function ejection fraction less than 50%; QT interval: male \\> 450 msec, female \\> 470 msec (according to the QTcF formula), or receiving known drugs that prolong QT\u002FQTc interval, or having other factors that may prolong QTc interval; or for those whose QT interval remains \\> 450 msec after treatment for QT interval prolongation;\n18. Participants with a history of other malignancies within the past 5 years, but excluding cured cutaneous basal cell carcinoma, localized skin squamous cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ;\n19. Participants with uncontrolled third space effusion (such as pleural effusion, ascites, pericardial effusion), requiring repeated drainage;\n20. Participants who have had interstitial lung disease (ILD)\u002Finterstitial pneumonia in the past or currently, and deemed by the investigator not suitable for inclusion in this study;\n21. Have a clear allergy to immunoglobulin or injectable belinotuzumab monoclonal antibody and its other components;\n22. Within the 4 weeks prior to the administration of this study, the participant has participated in other clinical trials of intervention drugs or medical devices, or is currently receiving treatment in other clinical trials (excluding non-interventional studies);\n23. Circumstances deemed unsuitable for participation in the trial by the investigator (such as, the investigator believes it may pose risks to the participant's safety or interfere with the evaluation, procedures, or completion of any other clinically significant medical history or having any other clinically significant disease at present (excluding those listed above).","ALL","18 Years",{"count":19,"type":20},212,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","A Randomized, Double-Blind, Positive-Controlled, Multicenter Clinical Study to Compare the Similarities in Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Injectable BLB101 and Blincyto® in Adult Participants with R\u002FR CD19+ B-ALL. Provide evidence for the approval and marketing of the drug for its targeted indication.\n\nPrimary Objectives：\n\n1. To compare the pharmacokinetic similarity between Injectable BLB101 and Blincyto® in participants with R\u002FR B-ALL.\n2. To compare the efficacy similarity between Injectable BLB101 and Blincyto® in participants with R\u002FR B-ALL.\n\nPrimary Endpoints:\n\n1. Css and area AUC0-24,d1 of Injectable BLB101 versus Blincyto® in participants with R\u002FR B-ALL.\n2. CR\u002FCRh within the first two induction cycles of treatment with Injectable BLB101 and Blincyto® in participants with R\u002FR B-ALL, as assessed by the IRC per the response criteria for ALL.\n\nThis study plans to enroll approximately 212 participants, who will be randomized at a 1:1 ratio into the following two groups:\n\nTest group: BLB101 for injection Control group: Blinatumomab for injection (Blincyto®) A stratified block randomization method will be adopted. The randomization stratification factors are as follows:a) Creatinine clearance (≤90 mL\u002Fmin vs \\>90 mL\u002Fmin);b) Baseline leukemic cell proportion (≤50% vs \\>50%);c) Relapsed\u002Frefractory status (first relapse vs ≥2 relapses or refractory disease).\n\nFor each participant, the overall study procedure is outlined as follows: Participants will receive treatment with either BLB101 for injection or Blincyto®. Each treatment cycle consists of 6 weeks, including 4 weeks of dosing followed by a 2-week treatment-free interval. Each participant is required to complete the first 2 induction treatment cycles (i.e., an induction treatment period of up to 12 weeks), after which the participant will be considered to have fulfilled the primary study objectives.",[26],"Precursor B-cell Acute Lymphoblastic Leukemia","NOT_YET_RECRUITING","2026-07-21",{"date":30,"type":31},"2026-07-23","ACTUAL",{"date":33,"type":20},"2026-08-09",{"date":35,"type":20},"2028-10-10",{"name":37,"class":38},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100574052","phase-2-venetoclax-combined-with-olverembatinib-and-predinisone-in-treating-ph-b-all-100574052","NCT06754267","Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph+ B-ALL","Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph-positive Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study","Inclusion Criteria:\n\n1. Before enrollment, the patient must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and positive for Philadelphia chromosome (presence of t(9;22) and\u002For BCR::ABL1 positive and\u002For FISH positive). The diagnostic criteria refer to the 2022 WHO classification;\n2. Age ≥ 18 years;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;\n4. Expected survival time ≥ 3 months;\n5. No organ dysfunction that would restrict the use of this protocol during the screening period;\n6. Understand the study and sign the informed consent form.\n7. Men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed effective by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Accelerated phase or blast crisis of chronic myeloid leukemia;\n2. Subjects with involvement of the central nervous system (CNS) or accompanied by extramedullary lesions;\n3. Subjects who have received systemic anti-leukemia treatment (including but not limited to TKI, radiotherapy or chemotherapy, except for the allowed pretreatment);\n4. Subjects with a history of myocardial infarction within 12 months, or have clinical manifestations of heart disease (including but not limited to unstable angina pectoris, congestive heart failure, uncontrolled hypertension and uncontrolled arrhythmia, etc.); left ventricular ejection fraction (LVEF) on echocardiography \\\u003C50%;\n5. Diseases with abnormal functions of organs such as lung, liver, and kidney that may limit the patient's participation in this trial (including but not limited to severe infection, uncontrolled diabetes, active tuberculosis, asthma, COPD, bronchiectasis, etc.);\n6. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;\n7. Serum total bilirubin \\> 1.5 ULN (upper limit of normal); ALT or AST \\> 2.5 ULN; serum creatinine \\> 1.5 ULN;\n8. Known HIV infection;\n9. Conditions affecting the use of the study drug as assessed by the investigator;\n10. Unable to understand or comply with the study protocol.",{"count":47,"type":20},36,[49],"PHASE2","Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Philadelphia chromosome positive (Ph+) ALL is defined as ALL with translocation between chromosomes 9 and 22. And t(9;22)(q34;q11) is the most common chromosomal abnormality in ALL. Before the emergence of TKI, the prognosis of Ph+ ALL was extremely poor, and the long-term survival rate was only 10%-35%. Ph+ ALL accounts for about 30% of adult ALL. In this study, the investigators propose a treatment approach that combines Venetoclax with Olverembatinib and Predinisone in Ph+ B-ALL adults. The study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.",[52],"Precursor B-Cell Acute Lymphoblastic Leukemia",[54,55,56,57],"acute lymphoblastic leukemia","Ph chromosome","BCL2 inhibitor","TKI","RECRUITING","2024-12-23",{"date":61,"type":31},"2024-12-31",{"date":63,"type":20},"2024-12",{"date":65,"type":20},"2027-12-30",{"name":67,"class":38},"First Affiliated Hospital of Zhejiang University",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":68},"100573148","phase-2-blinatumomab-plus-reduced-dose-chemotherapy-in-treating-b-all-100573148","NCT06742515","Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL","Blinatumomab Combined With Reduced-dose Chemotherapy in Treating Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study","Inclusion Criteria:\n\n* 1\\. Before enrollment, patients must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and be negative for Philadelphia chromosome. The diagnostic criteria refer to the 2022 WHO classification; 2. Age≥15 years， ≤59 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 4. Expected survival time ≥ 2 months; 5. No organ dysfunction that would restrict the use of this protocol during the screening period; 6. Understand the study and sign the informed consent form. 7. Men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed effective by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* 1\\. Patients with known central nervous system (CNS) involvement of ALL; 2. Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.); 3. Cardiac ultrasound LVEF \\\u003C 45%; 4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; 5. Serum total bilirubin \\> 1.5 ULN (upper limit of normal); ALT or AST \\> 2.5 ULN; serum creatinine \\> 1.5 ULN; 6. Known HIV infection; 7. Conditions affecting the use of the study drug as assessed by the investigator; 8. Unable to understand or comply with the study protocol.","15 Years","59 Years",{"count":79,"type":20},20,[49],"Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study，we propose a treatment approach that combines Blinatumomab and Reduced-dose Chemotherapy in B-ALL adults. Our study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.",[52],[84,85,86],"Acute Lymphoblastic Leukemia","Chemotherapy","Immunotherapy","2024-12-16",{"date":89,"type":31},"2024-12-19",{"date":91,"type":31},"2024-10-17",{"date":93,"type":20},"2028-08-31",{"name":67,"class":38}]