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NCT04447716 · ClinicalTrials.gov registry record · Phase 1
An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment
A Phase 1 study of Recurrent Follicular Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma, sponsored by Thomas Jefferson University.
- Active
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT04447716 is a Phase 1 study of Recurrent Follicular Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma that is active but no longer recruiting, run by Thomas Jefferson University. The registered enrollment target is 4 participants, below the 33-participant average among 20 other Recurrent Follicular Lymphoma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04447716, a Phase 1 study of Recurrent Follicular Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Thomas Jefferson University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of venetoclax when given together with lenalidomide and rituximab hyaluronidase in treating patients with follicular lymphoma and marginal zone lymphoma that has come back after treatment (relapsed) or has not responded to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking the action of a protein called Bcl-2, that helps cancer cells survive. Immunotherapy with lenalidomide, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as rituximab and rituximab hyaluronidase, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this research is to determine if the combination of three drugs, venetoclax, lenalidomide, and rituximab hyaluronidase are safe to administer in patients whose low-grade lymphoma (follicular or marginal zone) has come back after initial therapy or was not responsive to initial therapy.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Lenalidomide
- BIOLOGICAL Rituximab
- BIOLOGICAL Rituximab and Hyaluronidase Human
Study Locations (1)
Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-10-16 |
| Est. Completion | 2027-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04447716
The ClinicalTrials.gov registry entry for NCT04447716 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 33-participant average among 20 other Recurrent Follicular Lymphoma trials with a reported enrollment target (88% lower). The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Recurrent Follicular Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.
NCT04447716 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04447716 about?
NCT04447716 is a clinical study titled "An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment". This phase I trial studies the side effects and best dose of venetoclax when given together with lenalidomide and rituximab hyaluronidase in treating patients with follicular lymphoma and marginal zone lymphoma that has come back after treatment (relapsed) or has not responded to treatment (refracto...
What is the current status of trial NCT04447716?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2020-10-16. Estimated completion is 2027-04.
What conditions does trial NCT04447716 study?
This clinical trial studies the following conditions: Recurrent Follicular Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Marginal Zone Lymphoma, Refractory Follicular Lymphoma.
What interventions are being tested in trial NCT04447716?
The interventions under investigation include: Venetoclax (DRUG), Lenalidomide (DRUG), Rituximab (BIOLOGICAL), Rituximab and Hyaluronidase Human (BIOLOGICAL).
Who is sponsoring clinical trial NCT04447716?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04447716 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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