Safety and Effectiveness of Combining Low-dose Chemotherapy with Immuno-targeted Drugs for Newly Diagnosed Adults with Ph-negative B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating a new treatment approach for adults newly diagnosed with Philadelphia chromosome-negative Ph- B-cell acute lymphoblastic leukemia B-ALL, a type of blood cancer. Despite advances in chemotherapy and immunotherapy, treatment results remain less than ideal, especially for patients who cannot safely receive intensive therapies due to other health issues. This study aims to improve outcomes by combining immunotherapy drugs with low-dose chemotherapy to increase complete remission rates and reduce relapse risk. This open-label, single-arm Phase II clinical trial involves 53 adult patients with Ph- B-ALL. Participants receive induction therapy cycles that include immuno-targeted drugs such as Inotuzumab ozogamicin and Blinatumomab, combined with low-dose chemotherapy agents like vincristine, cyclophosphamide, dexamethasone, methotrexate, and cytarabine, along with Venetoclax. Consolidation and maintenance therapies continue with low-dose chemotherapy, Blinatumomab, and Venetoclax. When possible, patients may also receive CAR-T cell therapy or hematopoietic stem cell transplantation during their first complete remission. Participants will undergo assessments including measurable residual disease MRD testing by flow cytometry after induction therapy to evaluate remission status. The study monitors survival outcomes such as overall survival, relapse-free survival, and disease-free survival for up to five years after treatment. Safety is observed throughout, and patients are followed for at least five years post-maintenance therapy to track long-term effects and disease control.

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