Phase II Study of Daratumumab-Hyaluronidase Treatment for T Cell Acute Lymphoblastic Leukemia with Chemotherapy-Resistant Minimal Residual Disease

What this Trial Is About

Researchers are studying daratumumab-hyaluronidase as a treatment for T-cell Acute Lymphoblastic Leukemia T-ALL in patients who have persistent or returning minimal residual disease MRD after chemotherapy. The study aims to evaluate how well this treatment can eliminate MRD that does not respond to chemotherapy and improve survival outcomes. It also examines the treatments tolerability, especially after allogeneic stem cell transplant. Participants receive daratumumab-hyaluronidase injections 1800mg30,000 units once weekly for four weeks on Days 1, 8, 15, and 22. On Day 29, MRD status is assessed. Patients who are MRD negative continue daratumumab-hyaluronidase weekly for four more doses and then every two weeks for eight doses. Those who remain MRD positive receive daratumumab-hyaluronidase plus chemotherapy combinations on specific days as part of an intensified treatment course. During the study, participants will have evaluations including flow cytometry to measure MRD response on Days 29 and 64, along with assessments of survival outcomes and treatment tolerability. Researchers will monitor hematologic relapse, overall survival, and adverse effects. Participants are followed through treatment and response assessments to understand the therapys impact on MRD and relapse in T-ALL.

Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL