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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Tegavivint

    Drug

    Given IV

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Treatment (Tegavivint)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicity

1\) To be declared as dose-limiting toxicity, an adverse event must be related (definite, probable, or possible) to study treatment during the first cycle of therapy only (first 28 days). Any death at least possibly related to tegavivint will be a DLT. No DLTs observed thus far.

Time frame
At the end of Cycle 1 (each cycle is 28 days)
2

Maximum tolerated dose (MTD) for tegavivint

Determination of the MTD of tegavivint using a 3+3 design.

Time frame
At the end of Cycle 1 (each cycle is 28 days)
3

Determination of the recommended phase II dose (RP2D) of tegavivint

2\) This study uses a traditional "3+3" designs. We therefore anticipate a total sample size of 12 with the maximum expected sample size of 24. Primary endpoint not yet reached.

Time frame
At the end of Cycle 1 (each cycle is 28 days)

Secondary outcomes

1

Overall response rate (ORR)

Will be estimated by molecular subtype and across subtypes with exact 80% and 90% confidence intervals.

Time frame
After cycle 2 (each cycle is 28 days) or end of treatment
2

Complete response (CR) rate

Will be estimated by molecular subtype and across subtypes with exact 80% and 90% confidence intervals.

Time frame
At the end of Cycle 2 (each cycle is 28 days)
3

Duration of response (DOR)

Will be summarized by the Kaplan-Meier method, and two-year estimates will be provided with 80% and 90% confidence intervals, for each subtype and for all patients.

Time frame
Time from the date of first response until the first date of progression or death from any cause, assessed up to 2 years from study enrollment
4

Progression-free survival (PFS)

Will be summarized by the Kaplan-Meier method, and two-year estimates will be provided with 80% and 90% confidence intervals, for each subtype and for all patients.

Time frame
Time from the date of first treatment until the first date of progression or death from any cause, assessed up to 2 years from study enrollment

Other outcomes

1

Pharmacokinetic (PK) analysis AUC0-t

The reporting of pharmacokinetic parameters will be determined based on the final parameter analysis on the available data. Parameters will be assessed using AUC0-t

Time frame
Up to 14 weeks
2

Pharmacokinetic (PK) analysis AUC0-infinity

The reporting of pharmacokinetic parameters will be determined based on the final parameter analysis on the available data. Parameters will be assessed using AUC0-infinity.

Time frame
Up to 14 weeks
3

Pharmacokinetic (PK) analysis Tmax

The reporting of pharmacokinetic parameters will be determined based on the final parameter analysis on the available data. Parameters will be assessed using Tmax

Time frame
Up to 14 weeks
4

Pharmacokinetic (PK) analysis Cmax

The reporting of pharmacokinetic parameters will be determined based on the final parameter analysis on the available data. Parameters will be assessed using Cmax.

Time frame
Up to 14 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lapo Alinari

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov
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