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NCT05755087 · ClinicalTrials.gov registry record · Phase 1
Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma
A Phase 1 study of Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements and Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements, sponsored by Lapo Alinari.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05755087: Recruiting Phase 1 study of Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements and Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements, sponsored by Lapo Alinari.
NCT05755087 is a Phase 1 study of Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements and Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements that is actively recruiting participants, run by Lapo Alinari. The registered enrollment target is 18 participants, below the 51-participant average among 6 other Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05755087, a Phase 1 study of Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements and Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements, is actively recruiting participants, sponsored by Lapo Alinari.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- DRUG Tegavivint
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-03-06 |
| Est. Completion | 2028-03-05 |
| Phase | Phase 1 |
What NCT05755087 shows while recruiting
NCT05755087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 51-participant average among 6 other Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements trials with a reported enrollment target (65% lower).
The record links to 9 conditions, with Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05755087 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05755087 about?
NCT05755087 is a clinical study titled "Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma". 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 ...
What is the current status of trial NCT05755087?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-03-06. Estimated completion is 2028-03-05.
What conditions does trial NCT05755087 study?
This clinical trial studies the following conditions: 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, Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent, Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type.
What interventions are being tested in trial NCT05755087?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Tegavivint (DRUG).
Who is sponsoring clinical trial NCT05755087?
This trial is sponsored by Lapo Alinari, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05755087 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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