Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma
NCT ID: NCT05755087
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2023-03-06
2027-03-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
NCT05890352
Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT05672251
Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma
NCT07332507
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT05633615
Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
NCT05272384
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
II. To correlate response to tegavivint with TBL1 and c-Myc expression assessed by standard IHC on archived tumor biopsy.
III. To determine the effects of tegavivint on immune cell subsets viability and function.
OUTLINE: This is a dose-escalation study of tegavivint.
Patients receive tegavivint intravenously (IV) on study. Patients also undergo computed tomography (CT) and/or positron emission tomography (PET) and undergo blood sample collection throughout the trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Positron Emission Tomography
Undergo PET scan
Tegavivint
Given IV
Bone Marrow Biopsy
Undergo bone marrow biopsy and aspiration
Bone Marrow Aspiration
Undergo bone marrow biopsy and aspiration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Positron Emission Tomography
Undergo PET scan
Tegavivint
Given IV
Bone Marrow Biopsy
Undergo bone marrow biopsy and aspiration
Bone Marrow Aspiration
Undergo bone marrow biopsy and aspiration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 (NHL) to DLBCL
* Presence of BCL2 translocation with increased expression of MYC (≥40%) with or without MYC translocation
* Patients must have had at least two prior systemic therapies
* Patients must be ineligible for or refused autologous or allogenic hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy. Prior autologous stem cell transplant and/or CAR-T are allowed, if received \>= 3 months prior to enrollment
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* 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)
* Absolute neutrophil count (ANC) ≥ 500/mcL
* Platelet count ≥ 25,000/mcL
* Total bilirubin =\< 1.5 x the upper limit of the normal range (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 3 x institutional ULN
* Creatinine clearance \>= 60 ml/min by Cockcroft-Gault (actual body weight will be used to estimate creatinine clearance)
* Patients must be willing and able to understand and give written informed consent and comply with all study related procedures
* Women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use one hormonal contraceptive (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstain from sex for the duration of study participation and for 4 months following completion of tegavivint administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Contraception includes:
* Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
* Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient
* Use of oral (estrogen and progesterone), injected or implanted combined hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception
* Sexually active males must use a condom during intercourse while taking drug and for 4 months after stopping study treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
Exclusion Criteria
* 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
* Known history of active TB (Bacillus Tuberculosis)
* Major surgery within 3 weeks prior to start of study treatment
* Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality or corrected QT interval (QTc) \> 480 msec
* Uncontrolled concurrent illness including, but not limited to: ongoing or active infection (Viral, bacterial, fungal or other)
* Psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant and breastfeeding women are excluded from this study. The effects of tegavivint on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tegavivint
* Patients with abnormal serum chemistry values other than the specific limits detailed above, that in the opinion of the investigator is considered to be clinically significant, should be discussed with the Study PI before being enrolled in the study
* Personal history of malignancy except:
* Cervical intraepithelial neoplasia;
* Skin basal cell carcinoma;
* Treated localized prostate carcinoma with prostate specific antigen (PSA) \<1 ng/mL or untreated indolent prostate cancer
* Neoplasia treated with curative intent, in remission for at least three years and considered at low risk of relapse
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lapo Alinari
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lapo Alinari
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lapo Alinari, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
The Jamesline
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2023-00200
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-21359
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.