Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma (NCT05755087) | Clinical Trial Compass
RecruitingPhase 1
Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma
United States18 participantsStarted 2023-03-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
One of the following three conditions:
* 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 aminotran…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose-limiting toxicity
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
2
Maximum tolerated dose (MTD) for tegavivint
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
3
Determination of the recommended phase II dose (RP2D) of tegavivint
Timeframe: At the end of Cycle 1 (each cycle is 28 days)