OncoMatch/Clinical Trials/NCT06387121

Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL

Is NCT06387121 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for precursor cell lymphoblastic leukemia-lymphoma.

Treatment: Vincristine · Cyclophosphamide · Dexamethasone · Venetoclax · Inotuzumab ozogamicin · Blinatumomab · 6-mercaptopurine · Methotrexate · Cytarabine · Prednisone — 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.