About this trial
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.
Eligibility criteria
Qualifiers
Newly diagnosed, previously untreated (except prednisone/hydroxyurea) Ph-negative ALL
Age ≥14 years, ≤60 years
ECOG performance status ≤2
Adequate organ function (liver, kidney, cardiac)
Disqualifiers
Burkitt leukemia/lymphoma
Acute leukemia of ambiguous lineage
Pregnancy or lactation
Severe uncontrolled active infection
Trial design
Treatments tested in this trial
- VDCLP+V
- 2VIP
- Consolidation Therapy
- Maintenance Therapy
- Blinatumomab
- Venetoclax
- CNS Prophylaxis
- CAR-T Cell Therapy
- Hematopoietic Stem Cell Transplantation (HSCT)