Tegavivint

Undergo bone marrow biopsy and aspiration

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.

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.

Registro actualizado en ClinicalTrials.gov →

• Increased expression of MYC (>= 40%) and BCL2 (>= 50%) by immunohistochemistry (IHC) or
• Presence of isolated MYC translocation Or
• Relapsed/refractory histologically confirmed high-grade B-cell lymphoma (HGBCL) (double hit [DH] and triple hit [TH]) with translocations of MYC and BCL2 and/or BCL6 Or
• Histologic transformation of indolent non-Hodgkin's lymphoma (NHL) to DLBCL

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.