Phase 1b Study of Intravenous Tegavivint for Adults with Relapsed or Refractory Large B-Cell Lymphoma Overexpressing c-Myc

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of tegavivint in adults with relapsed or refractory large B-cell lymphomas that overexpress c-Myc. This phase I trial focuses on patients whose lymphoma has returned or does not respond to treatment and aims to find a recommended dose and assess early signs of effectiveness. The study also explores how certain genetic mutations and protein expressions relate to treatment response and effects on immune cells. Participants receive tegavivint intravenously over four hours on days 1, 8, 15, and 22 of each 28-day cycle. Treatment continues unless the disease progresses or unacceptable side effects occur. Throughout the trial, patients undergo imaging scans like CT and PET to monitor disease status and have blood samples collected. Bone marrow biopsies and aspirations may also be performed during screening and treatment. During the study, researchers assess safety by monitoring dose-limiting toxicities and determining the maximum tolerated dose and recommended phase II dose after the first cycle. They also evaluate response rates, including complete response, and track how long responses last and survival outcomes for up to two years. Regular imaging, blood tests, and possibly bone marrow evaluations help measure these outcomes and monitor patient health throughout the trial.

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma