Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL
Efficacy and Safety of Low-dose Chemotherapy Combined With Immuno-targeted Drugs in Newly Diagnosed Adult Patients With Ph-negative B-cell Acute Lymphocytic Leukemia: A Prospective, Single-arm Clinical Study
About This Trial
In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL) among adult patients, therapeutic outcomes remain suboptimal despite advances in chemotherapy and immunotherapy. A subset of adults with Ph- B-ALL have comorbidities or physiological limitations that preclude the safe administration of intensive regimens. In recent years, tumor immunotherapy has demonstrated promising safety and efficacy profiles in refractory or relapsed Ph- B-ALL across a wide spectrum of adult ages. These findings suggest that broader application of immunotherapy may represent a critical strategy to improve survival in this population. In this study, we propose a regimen that combines immuno-targeted agents with low-intensity chemotherapy for newly diagnosed adult patients with Ph- B-ALL. Our primary objective is to increase the rate of measurable residual disease (MRD)-negative complete remission (CR) following induction therapy, reduce the risk of relapse, and ultimately enhance overall survival.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Vincristine
Anti-tumor alkaloids
Cyclophosphamide
Alkylating agent
Dexamethasone
Glucocorticoids
Venetoclax
Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Inotuzumab ozogamicin
A humanized monoclonal antibody-drug conjugate targeting CD22
Blinatumomab
Bi-specific anti-CD19/CD3 antibodies
6-mercaptopurine
Cell cycle-specific antitumor drug
Methotrexate
Antifolate antineoplastic drug
Cytarabine
Pyrimidine antimetabolites
Prednisone
Glucocorticoids