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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Lapo Alinari
Study ID
NCT05755087
Phase
PHASE1
Status
Recruiting
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Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type
  • Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
  • Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Tegavivint — DRUG
    Given IV
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow biopsy and aspiration

Study Details

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.

Key Dates

Start date
Mar 6, 2023
Status verified
Feb 2026
Primary completion
Mar 5, 2028
Completion
Mar 5, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Tegavivint)
    Patients receive tegavivint IV over 4 hours on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET and undergo blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy and aspirate during screening and on the trial.

Primary Outcome Measure

Incidence of dose-limiting toxicity [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Lapo Alinari, MD, PhD
[email protected]
614-293-5594
Lapo Alinari, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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