Study of Non-intensive Treatment for Adults Aged 18 to 55 with Ph-negative Acute Lymphoblastic Leukemia Using MRD-Directed Therapy

What this Trial Is About

This trial studies adult patients aged 18 to 55 with Philadelphia chromosome-negative acute lymphoblastic leukemia Ph-negative ALL. It evaluates a non-intensive but continuous treatment approach based on previous research RALL-2016, focusing on minimizing high-dose chemotherapy while targeting minimal residual disease MRD status to guide therapy. Specialized therapies are given to patients with persistent MRD after initial treatment phases to improve disease-free survival. The treatment includes a 7-day prednisolone prephase followed by 8 weeks of induction chemotherapy with reduced intensity. For patients reaching complete remission but still MRD-positive, T-cell ALL patients receive consolidation therapy with venetoclax for 56 days, and B-cell ALL patients receive one consolidation with blinatumomab. Therapy continues with five consolidation phases and two years of maintenance, including 21 intrathecal injections throughout. MRD is closely monitored at specified intervals, and allogeneic stem cell transplant is reserved for very high-risk patients. Participants undergo regular assessments including MRD testing using flow cytometry at multiple time points, bone marrow sample collection after consolidation, and safety monitoring. Researchers measure disease-free survival over three years as the primary outcome, with MRD-negativity and overall survival as secondary outcomes. The study duration includes treatment and follow-up, emphasizing continuous therapy without interruption based on MRD results.

MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients