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NCT05600686 · ClinicalTrials.gov registry record · Phase 2
Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma
A Phase 2 study of High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements and Double-Expressor Lymphoma, sponsored by Joseph Tuscano.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT05600686: Recruiting Phase 2 study of High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements and Double-Expressor Lymphoma, sponsored by Joseph Tuscano.
NCT05600686 is a Phase 2 study of High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements and Double-Expressor Lymphoma that is actively recruiting participants, run by Joseph Tuscano. The registered enrollment target is 24 participants, below the 90-participant average among 8 other High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements trials with a reported enrollment target (73% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05600686, a Phase 2 study of High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements and Double-Expressor Lymphoma, is actively recruiting participants, sponsored by Joseph Tuscano.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial evaluates whether loncastuximab tesirine and rituximab followed by dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone works to treat patients with high risk diffuse large B-cell lymphoma. Loncastuximab tesirine is a monoclonal antibody called loncastuximab, linked to a drug called tesirine. It is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs such as doxorubicin, vincristine, and cyclophosphamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving loncastuximab tesirine and rituximab in combination with dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone may be more effective at treating high risk diffuse large B-cell lymphoma patients than standard treatments.
Primary Outcome
Evaluated per 2014 Lugano criteria. An exact 95% confidence interval will be calculated.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Etoposide
- DRUG Prednisone
- BIOLOGICAL Loncastuximab Tesirine
Study Locations (2)
California
- University of California Davis Comprehensive Cancer Center - Sacramento
- UC San Diego Moores Cancer Center - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-05-24 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 2 |
What NCT05600686 shows while recruiting
NCT05600686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 90-participant average among 8 other High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements trials with a reported enrollment target (73% lower).
The record links to 4 conditions, with High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05600686 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05600686 about?
NCT05600686 is a clinical study titled "Loncastuximab Tesirine and Rituximab Followed by DA-EPOCH-R for Treating Patients With High-Risk Diffuse Large B-cell Lymphoma". This phase II trial evaluates whether loncastuximab tesirine and rituximab followed by dose-adjusted doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone works to treat patients with high risk diffuse large B-cell lymphoma. Loncastuximab tesirine is a monoclonal antibody called lonc...
What is the current status of trial NCT05600686?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2023-05-24. Estimated completion is 2028-02-01.
What conditions does trial NCT05600686 study?
This clinical trial studies the following conditions: High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, Double-Expressor Lymphoma, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements.
What interventions are being tested in trial NCT05600686?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Etoposide (DRUG), Prednisone (DRUG), Loncastuximab Tesirine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05600686?
This trial is sponsored by Joseph Tuscano, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05600686 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05600686's enrollment target sits among peer trials
24 7th of 8 higher than 2 of 8 other High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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