Phase Ib Trial of Tegavivint in Patients With Relapsed/Refractory C-MYC Overexpressing Large B-Cell Lymphoma
Lapo Alinari
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: One of the following three conditions: * Relapsed/refractory histologically confirmed germinal center B-cell-like (GCB) and non-GCB diffuse large B cell lymphoma (DLBCL) with the following features: * 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…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- ProcedurePositron Emission Tomography
Undergo PET scan
- DrugTegavivint
Given IV
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy and aspiration
- ProcedureBone Marrow Aspiration
Undergo bone marrow biopsy and aspiration
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio