Study of Asciminib as Maintenance Therapy After Stem Cell or CAR T Cell Treatments in Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of asciminib as a maintenance treatment for adults with Philadelphia chromosome positive acute lymphoblastic leukemia Ph ALL who have undergone cellular therapies such as hematopoietic stem cell transplantation HSCT or chimeric antigen receptor CAR T cell therapy. This phase I trial aims to help prevent cancer from returning after initial therapy has eliminated it by blocking enzymes needed for cancer cell growth. The study also investigates recommended dosing and other important outcomes like relapse rates and survival. Participants receive asciminib orally once or twice daily on days 1 to 28 of each 28-day cycle, continuing for up to 12 cycles unless the disease progresses or side effects become unacceptable. This is a dose-escalation study followed by a dose-expansion phase. During the study, patients undergo tests including echocardiography, bone marrow biopsy, bone marrow aspiration, and blood sample collection. These procedures help monitor treatment effects and safety. Throughout the trial, participants are closely observed with regular assessments of blood and marrow, imaging as needed, and quality of life surveys. After completing treatment, patients have follow-up visits at 30 days and then every 3 months for one year to monitor relapse, survival, side effects, and other outcomes. The main outcome measured is the occurrence of adverse events during the first treatment cycle.

Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia