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NCT04462328 · ClinicalTrials.gov registry record · Phase 1
Acalabrutinib and Durvalumab in Primary and Secondary Central Nervous System Lymphoma
A Phase 1 study of Primary Central Nervous System Lymphoma, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT04462328 is a Phase 1 study of Primary Central Nervous System Lymphoma that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 25 participants, below the 51-participant average among 12 other Primary Central Nervous System Lymphoma trials with a reported enrollment target (51% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04462328, a Phase 1 study of Primary Central Nervous System Lymphoma, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
BTK inhibition and checkpoint blockade are promising classes of therapy for central nervous system (CNS) lymphoma and have demonstrated efficacy with acceptable toxicity. A multidrug approach may carry a higher chance of durable efficacy in this aggressive disease that carries significant morbidity and mortality. Given the poor outcomes and limited options for patients who are not candidates for high-dose methotrexate, the investigators seek to evaluate the combination in this patient population. 08/30/2022: The study was originally designed for those with primary and secondary central nervous system (CNS) lymphoma. However, the first three patients who were enrolled all had secondary CNS lymphoma and most had germinal center phenotype disease with double hit phenotypes. In these three patients, two dose limiting toxicities were seen including 1 patient with grade 4 neutropenia at the time of disease progression and one with pneumonia in the setting of disease progression and worsening of existing heart disease. The third patient came off for clinical progression within cycle 1. Given the lack of response in patients with secondary CNS lymphomas, who do not exhibit the same biology as primary CNS lymphoma patients, Amendment 3 updates the study to only include patients with primary CNS lymphomas.
Conditions Studied
Interventions
- DRUG Acalabrutinib
- DRUG Durvalumab
Study Locations (2)
Missouri
- Washington University School of Medicine - St Louis
Ohio
- The Ohio State University Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-04-29 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04462328
The ClinicalTrials.gov registry entry for NCT04462328 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 51-participant average among 12 other Primary Central Nervous System Lymphoma trials with a reported enrollment target (51% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Central Nervous System Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Acalabrutinib is the first listed.
NCT04462328 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Missouri, Ohio.
Frequently Asked Questions
What is clinical trial NCT04462328 about?
NCT04462328 is a clinical study titled "Acalabrutinib and Durvalumab in Primary and Secondary Central Nervous System Lymphoma". BTK inhibition and checkpoint blockade are promising classes of therapy for central nervous system (CNS) lymphoma and have demonstrated efficacy with acceptable toxicity. A multidrug approach may carry a higher chance of durable efficacy in this aggressive disease that carries significant morbidity ...
What is the current status of trial NCT04462328?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2021-04-29. Estimated completion is 2028-05-31.
What conditions does trial NCT04462328 study?
This clinical trial studies the following conditions: Primary Central Nervous System Lymphoma.
What interventions are being tested in trial NCT04462328?
The interventions under investigation include: Acalabrutinib (DRUG), Durvalumab (DRUG).
Who is sponsoring clinical trial NCT04462328?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04462328 being conducted?
This trial has 2 study locations across Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.