Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
Study summary
This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.
At a glance
- Conditions
- Acute Lymphoblastic Leukemia, Adult
- Interventions
- VDCLP+V, 2VIP, Consolidation Therapy, Maintenance Therapy, Blinatumomab, Venetoclax, CNS Prophylaxis, CAR-T Cell Therapy, Hematopoietic Stem Cell Transplantation (HSCT)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Target enrollment
- 43 participants
- Age
- 14 Years – 60 Years
- Sex
- ALL
- Locations
- Blood Diseases Hospital
- Registry
- View on ClinicalTrials.gov ↗