Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Recurrent Follicular Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma, sponsored by Thomas Jefferson University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Toxicity incidences assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, will be tabulated by patient cohort.
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 |
What the registry record for NCT04447716 still lists
NCT04447716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 33-participant average among 20 other Recurrent Follicular Lymphoma trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Recurrent Follicular Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04447716's enrollment target sits among peer trials
4 21st of 20 the lowest of 20 other Recurrent Follicular Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Follicular Lymphoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Q702 for the Treatment of Patients With Hematologic Malignancies
RECRUITING · Phase 1
-
B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies
RECRUITING · Phase 1
-
Nivolumab and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma
ACTIVE NOT RECRUITING · Phase 1
-
Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment
ACTIVE NOT RECRUITING · Phase 1
-
Modified Immune Cells (CD19/CD20 CAR-T Cells) in Treating Patients With Recurrent or Refractory B-Cell Lymphoma or Chronic Lymphocytic Leukemia
ACTIVE NOT RECRUITING · Phase 1
-
Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI