Health Trials

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

ConditionsRecurrent Diffuse Large B-Cell Lymphoma Activated B-Cell TypeRecurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell TypeRecurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRefractory Diffuse Large B-Cell Lymphoma Activated B-Cell TypeRefractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell TypeRefractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsTransformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLapo Alinari

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

History of allergic reactions attributed to compounds of similar chemical or biologic composition to tegavivint or other agents used in study

Known active central nervous system (CNS) lymphoma, history of CNS involvement allowed if in remission for >= 3 months

Evidence of chronic active Hepatitis B, chronic active Hepatitis C infection

Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy (e.g., strong CYP3A inhibitors and/or concomitant medications that are excluded) are ineligible because of the potential for pharmacokinetic interactions with tegavivint

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Positron Emission Tomography
  • Tegavivint
  • Bone Marrow Biopsy
  • Bone Marrow Aspiration

Treatment groups

18 Participants
are divided into 1 treatment group

Sponsors and collaborators

Lapo Alinari

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov