Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements Clinical Trial
Official title:
Phase Ib Trial of Tegavivint in Patients With Relapsed/Refractory C-MYC Overexpressing Large B-Cell Lymphoma
This phase I trial tests the safety, side effects, and best dose of tegavivint in treating patients with large b-cell lymphomas that has come back (relapsed) or does not respond to treatment (refractory). Tegavivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tegavivint may help control the disease.
PRIMARY OBJECTIVES: I. To determine the safety and tolerability of tegavivint in patients with relapsed/refractory c-Myc overexpressing large B-cell lymphoma. II. To determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of tegavivint. SECONDARY OBJECTIVES: I. To determine the preliminary efficacy of tegavivint in patients with relapsed/refractory c-Myc overexpressing large B-cell lymphoma. II. To determine the pharmacokinetic parameters of tegavivint. EXPLORATORY OBJECTIVES: I. To correlate response to tegavivint with the presence of MYC, FBW7 and SKP2 mutations. II. To correlate response to tegavivint with TBL1 and c-Myc expression assessed by standard IHC on archived tumor biopsy. III. To determine the effects of tegavivint on immune cell subsets viability and function. OUTLINE: This is a dose-escalation study of tegavivint. Patients receive tegavivint intravenously (IV) on study. Patients also undergo computed tomography (CT) and/or positron emission tomography (PET) and undergo blood sample collection throughout the trial. ;
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