[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642813":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":72,"locations":30,"responsibleParty":78,"collaborators":30,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":30,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":30,"overallStatus":99,"whyStopped":30,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":30},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Immuno-Targeted Therapy Plus Low-Dose Chemotherapy","EXPERIMENTAL","Adult patients with newly diagnosed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (Ph- B-ALL) receive frontline treatment with immuno-targeted agents, a BCL2 inhibitor, and low-dose chemotherapy. Induction therapy includes inotuzumab ozogamicin, venetoclax, vincristine, cyclophosphamide, and dexamethasone. Subsequent treatment is adapted according to measurable residual disease (MRD) response, antigen expression profile, and clinical condition, and may include blinatumomab-based immunotherapy, venetoclax-containing chemotherapy, CD19-directed CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients proceed to protocol-defined maintenance therapy.",[13,14,15,16,17,18,19,20,21,22,23],"Drug: Inotuzumab Ozogamicin (IO)","Drug: Venetoclax","Drug: Blinatumomab","Biological: CD19-directed chimeric antigen receptor (CAR-T) T cells","Drug: Vincristine","Drug: Cyclophosphamide","Drug: Dexamethasone","Drug: Methotrexate","Drug: Cytarabine (Ara-C)","Drug: Prednisone","Drug: Mercaptopurine 50 mg",[25,31,35,39,44,48,52,56,60,64,68],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Inotuzumab Ozogamicin (IO)","Anti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Venetoclax","BCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis.",[9],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Blinatumomab","CD19\u002FCD3 bispecific T-cell engager (BiTE) administered as continuous intravenous infusion during consolidation therapy.",[9],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":30},"BIOLOGICAL","CD19-directed chimeric antigen receptor (CAR-T) T cells","Autologous CD19 CAR-T cell therapy administered as a single intravenous infusion as optional consolidation therapy for eligible patients.",[9],{"type":26,"name":45,"description":46,"armGroupLabels":47,"otherNames":30},"Vincristine","A vinca alkaloid that inhibits microtubule formation by binding to tubulin, resulting in mitotic arrest and inhibition of proliferation of rapidly dividing leukemic cells.",[9],{"type":26,"name":49,"description":50,"armGroupLabels":51,"otherNames":30},"Cyclophosphamide","An alkylating agent that forms DNA cross-links, leading to inhibition of DNA replication and transcription and subsequent apoptosis of rapidly proliferating hematopoietic cells.",[9],{"type":26,"name":53,"description":54,"armGroupLabels":55,"otherNames":30},"Dexamethasone","A synthetic glucocorticoid that induces lymphoid cell apoptosis and exerts anti-inflammatory and immunosuppressive effects, contributing to reduction of leukemic burden.",[9],{"type":26,"name":57,"description":58,"armGroupLabels":59,"otherNames":30},"Methotrexate","A folate antimetabolite that inhibits dihydrofolate reductase, resulting in impaired DNA synthesis and cell replication, particularly in rapidly dividing lymphoid cells.",[9],{"type":26,"name":61,"description":62,"armGroupLabels":63,"otherNames":30},"Cytarabine (Ara-C)","A pyrimidine nucleoside analog that inhibits DNA polymerase, leading to termination of DNA chain elongation and inhibition of leukemic cell proliferation.",[9],{"type":26,"name":65,"description":66,"armGroupLabels":67,"otherNames":30},"Prednisone","A glucocorticoid that induces apoptosis in lymphoid cells and provides anti-inflammatory and immunosuppressive effects as part of multi-agent leukemia therapy.",[9],{"type":26,"name":69,"description":70,"armGroupLabels":71,"otherNames":30},"Mercaptopurine 50 mg","A purine analog antimetabolite that interferes with purine nucleotide synthesis and incorporates into DNA and RNA, inhibiting nucleic acid synthesis and cell proliferation.",[9],[73],{"name":74,"role":75,"phone":76,"phoneExt":30,"email":77},"Ying Wang, MD, PhD","CONTACT","+86 22-23608095","wangying1@ihcams.ac.cn",{"type":79,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100642813","phase-2-immuno-targeted-therapy-plus-low-dose-chemotherapy-for-newly-diagnosed-adult-ph-negative-b-all-a-prospective-umbrella-trial-100642813",false,"NCT07643103","Immuno-Targeted Therapy Plus Low-Dose Chemotherapy for Newly Diagnosed Adult Ph-Negative B-ALL: A Prospective Umbrella Trial","A Prospective Umbrella Clinical Trial of Immuno-Targeted Agents Combined With Low-Dose Chemotherapy for Newly Diagnosed Adult Philadelphia Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia","Ph- ALL-2026","Inclusion Criteria:\n\n1. Newly diagnosed adult (≥18 years) patients with Ph-negative B-cell acute lymphoblastic leukemia according to WHO 2022 criteria.\n2. CD22-positive expression on tumor cells (CD22 ≥20%).\n3. Expected survival ≥3 months.\n4. Sexually active men and women of childbearing potential must agree to use effective contraception.\n5. Ability to understand and voluntarily sign informed consent, and willingness to comply with study requirements. Informed consent must be signed by the patient or a legal next of kin prior to initiation of any study-specific procedures.\n\nExclusion Criteria:\n\n1. Burkitt lymphoma\u002Fleukemia.\n2. Acute leukemia of ambiguous lineage.\n3. Pregnant women.\n4. Severe, uncontrolled active infections.\n5. History of chronic liver disease (e.g., liver cirrhosis) or prior veno-occlusive disease (VOD) \u002F sinusoidal obstruction syndrome (SOS).\n6. History of clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal), or sinus node dysfunction or high-grade atrioventricular (AV) block with chronic bradycardia, unless a permanent pacemaker has been implanted.\n7. Uncontrolled active hepatitis B or hepatitis C infection, or known HIV seropositivity. HIV testing may be required according to local regulations or standards.\n8. Psychiatric disorders that may impair the subject's ability to complete treatment or provide informed consent.\n9. Any other conditions deemed by the investigator to render the subject unsuitable for participation in the study.","ALL","18 Years",{"count":91,"type":92},32,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 32 adult patients with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL). All patients receive a frontline treatment backbone consisting of low-dose chemotherapy combined with immuno-targeted agents and a BCL2 inhibitor. Subsequent treatment pathways are guided by MRD response, disease characteristics, and clinical decision-making, including antibody-based immunotherapy, CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients continue protocol-defined maintenance therapy after consolidation.\n\nThe primary endpoint is the complete remission rate with negative flow cytometric MRD after induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated according to NCI CTCAE version 5.0.",[98],"Ph- Acute Lymphoblastic Leukemia (Ph-ALL)","NOT_YET_RECRUITING","2026-06-08",{"date":102,"type":103},"2026-06-11","ACTUAL",{"date":105,"type":92},"2026-06-12",{"date":107,"type":92},"2030-05-31",{"name":5,"class":6}]