Immuno-Targeted Therapy Plus Low-Dose Chemotherapy for Newly Diagnosed Adult Ph-Negative B-ALL: A Prospective Umbrella Trial
Summary
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. The 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.
Timeline
- Start
- 2026-06-12
- Primary completion
- 2028-05-31
- Completion
- 2030-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Blinatumomab | Monoclonal antibody | — | Intravenous |
| Subject | CD19-directed chimeric antigen receptor (CAR-T) T cells | Cell therapy | — | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Cytarabine | Small molecule | — | — |
| Subject | Dexamethasone | Small molecule | — | — |
| Subject | Inotuzumab Ozogamicin | Monoclonal antibody | — | Intravenous |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 50 mg | — |
| Subject | Methotrexate | Small molecule | — | — |
| Subject | Prednisone | Other / unclassified | — | — |
| Subject | Venetoclax | Small molecule | — | Oral |
| Subject | Vincristine | Small molecule | — | — |