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NCT04609046 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma
A Phase 1 study of Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 20
- Study locations
NCT04609046: Recruiting Phase 1 study of Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System, sponsored by National Cancer Institute (NCI).
NCT04609046 is a Phase 1 study of Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04609046, a Phase 1 study of Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).
Primary Outcome
Defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). The number and severity of all adverse events will be tabulated and summarized in this patient population both overall and by dose level according to the Common Terminology Criteria for Adverse Events (CTCAE) Cancer Therapy Evaluation Program version 5.0 criteria. The grade 3+ adverse events will also be described and summarized in a s
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Lumbar Puncture
- PROCEDURE Echocardiography Test
- DRUG Lenalidomide
- PROCEDURE Bone Marrow Aspiration and Biopsy
Study Locations (20)
Iowa
- UI Health Care Mission Cancer and Blood - Ankeny Clinic - Ankeny
- Saint Anthony Regional Hospital - Carroll
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic - Clive
- Iowa Methodist Medical Center - Des Moines
- UI Health Care Mission Cancer and Blood - Des Moines Clinic - Des Moines
- Broadlawns Medical Center - Des Moines
- Mercy Medical Center - Des Moines - Des Moines
- UI Health Care Mission Cancer and Blood - Laurel Clinic - Des Moines
- Iowa Lutheran Hospital - Des Moines
- UI Healthcare Mission Cancer and Blood - Fort Dodge - Fort Dodge
- UI Health Care Mission Cancer and Blood - Waukee Clinic - Waukee
- Methodist West Hospital - West Des Moines
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- University of Miami Sylvester Comprehensive Cancer Center at Sole Mia - North Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
California
- Cedars Sinai Medical Center - Los Angeles
- UCSF Medical Center-Parnassus - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2021-05-24 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
What NCT04609046 shows while recruiting
NCT04609046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT04609046 names 20 study sites across 3 states, led by Iowa, Florida, California.
Frequently Asked Questions
What is clinical trial NCT04609046 about?
NCT04609046 is a clinical study titled "Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma". This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the g...
What is the current status of trial NCT04609046?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2021-05-24. Estimated completion is 2026-05-31.
What conditions does trial NCT04609046 study?
This clinical trial studies the following conditions: Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System.
What interventions are being tested in trial NCT04609046?
The interventions under investigation include: Computed Tomography (PROCEDURE), Lumbar Puncture (PROCEDURE), Echocardiography Test (PROCEDURE), Lenalidomide (DRUG), Bone Marrow Aspiration and Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT04609046?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04609046 being conducted?
This trial has 20 study locations across California, Florida, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04609046's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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