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Beta-catenin Inhibitor

Tegavivint for Large B-Cell Lymphoma

Phase 1

Recruiting

Led By Lapo Alinari, MD, PhD

Research Sponsored by Lapo Alinari

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologic transformation of indolent non-Hodgkin's lymphoma (NHL) to DLBCL with increased expression of MYC (>= 40%) and BCL2 (>= 50%) by IHC and presence of MYC and BCL2 translocation

Patients must have radiographically measurable disease by standard positron emission tomography (PET) uptake with at least one site of measured disease by standardized uptake value (SUV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the date of first treatment until the date of death from any cause, assessed up to 2 years from study enrollment

Awards & highlights

Study Summary

This trial tests a new drug to fight relapsed/refractory lymphomas, which may stop cancer growth by blocking enzymes.

Who is the study for?

Adults with relapsed or refractory large B-cell lymphoma who have tried at least two treatments and can't or won't get stem cell transplant or CAR T-cell therapy. They must have measurable disease, adequate organ function, agree to use contraception, and not be pregnant. Excluded are those with certain infections, recent major surgery, other active cancers (with exceptions), uncontrolled illnesses, known allergies to similar drugs, HIV on specific treatments, active CNS lymphoma.Check my eligibility

What is being tested?

The trial is testing the safety and optimal dosage of a drug called tegavivint for patients whose large B-cell lymphomas have returned after treatment or haven’t responded to previous therapies. The study involves collecting biospecimens and using imaging tests like CT scans and PET scans to monitor the effects.See study design

What are the potential side effects?

Potential side effects of tegavivint may include risks during pregnancy (hence contraception requirements), possible allergic reactions for those sensitive to similar compounds. Specific side effects aren't listed but generally could involve typical chemotherapy-related issues such as fatigue, nausea, blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My slow-growing lymphoma has changed into a more aggressive type with specific genetic changes.

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My cancer can be seen and measured on a PET scan.

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My lymphoma is a type that has come back or didn’t respond to treatment and involves specific gene changes.

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I have undergone at least two different treatments for my condition.

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My kidneys are functioning well, with a creatinine clearance rate of 60 ml/min or higher.

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I am 18 years old or older.

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My lymphoma has specific genetic features and has not responded to treatment.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the date of first treatment until the date of death from any cause, assessed up to 2 years from study enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the date of first treatment until the date of death from any cause, assessed up to 2 years from study enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the date of first treatment until the date of death from any cause, assessed up to 2 years from study enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Incidence of dose-limiting toxicity

Maximum tolerated dose (MTD) for tegavivint

Secondary outcome measures

Complete response (CR) rate

Duration of response (DOR)

Event-free survival (EFS)

+3 more

Other outcome measures

Pharmacokinetic (PK) analysis AUC0-infinity

Pharmacokinetic (PK) analysis AUC0-t

Pharmacokinetic (PK) analysis Cmax

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Tegavivint)Experimental Treatment4 Interventions

Patients receive tegavivint IV on study. Patients also undergo CT and/or PET and undergo blood sample collection throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

Tegavivint

2018

Completed Phase 1

~30

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lapo AlinariLead Sponsor

Lapo Alinari, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

1 Previous Clinical Trials

18 Total Patients Enrolled

Media Library

Tegavivint (Beta-catenin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05755087 — Phase 1

Diffuse Large B-Cell Lymphoma Research Study Groups: Treatment (Tegavivint)

Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Tegavivint Highlights & Side Effects. Trial Name: NCT05755087 — Phase 1

Tegavivint (Beta-catenin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05755087 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential perils are associated with Tegavivint?

"Our team at Power assessed the safety of Treatment (Tegavivint) to be a 1 due to it being in phase 1 and lacking substantial evidence for its efficacy and harmlessness."

Answered by AI

Is recruitment currently active for this research initiative?

"The information found on clinicaltrials.gov suggests that this medical trial is not currently looking for volunteers; it was first shared on March 31st 2023 and the most recent update occurred on March 2nd of the same year. However, there are over two thousand six hundred other studies actively seeking participants as of now."

Answered by AI

What is the ultimate goal of this research project?

"This study aims to determine the Maximum Tolerated Dose (MTD) of tegavivint over a period spanning four 28-day cycles. Secondary outcomes will include Progression-Free Survival, Event-Free Survival and Overall Response Rate - all measured with Kaplan Meier Methodology and reported within 80% and 90% confidence intervals for each subtype or across all patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Lapo Alinari 2023. "Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05755087.