Randomized Study of New Immunotherapies and Stem Cell Transplantation for Adults Aged 18-65 with Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are studying adult acute lymphoblastic leukemia ALL, including its three main types Ph-positive ALL, Ph-negative B-cell precursor ALL, and T-ALLlymphoblastic lymphoma. The study aims to improve frontline treatment outcomes by incorporating new antibody-based therapies and refining when allogeneic hematopoietic stem cell transplantation HSCT is needed in first remission. Current treatments have improved survival but there is still potential for better results, especially by reducing relapse and improving survival with new immunotherapies. The trial is a prospective, multicenter, multi-country randomized study with three cohorts based on ALL subtype Ph-negative BCP-ALL, Ph-positive ALL, and T-ALLLL. Treatments include standard chemotherapy, blinatumomab an anti-CD19 antibody, ponatinib a tyrosine kinase inhibitor, and isatuximab an anti-CD38 antibody depending on the cohort. Some participants receive HSCT as standard care. These treatments are given in cycles with specific dosing schedules, including intravenous infusions and oral medications, from induction through maintenance phases. Participants will be closely monitored through scheduled visits involving blood tests, measurable residual disease assessments, physical exams, and questionnaires to track treatment effects and safety. Researchers will measure outcomes such as overall survival, event-free survival, relapse rates, and quality of life over a period of up to five years. Safety and adverse events will also be recorded, with ongoing assessments to evaluate how well the new therapies work and their impact on participants health.

A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia