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NCT04257578 · ClinicalTrials.gov registry record · Phase 1
Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma
A Phase 1 study of High Grade B-Cell Lymphoma and B-Cell Non-Hodgkin Lymphoma, sponsored by University of Washington.
- Active
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT04257578: Active Phase 1 study of High Grade B-Cell Lymphoma and B-Cell Non-Hodgkin Lymphoma, sponsored by University of Washington.
NCT04257578 is a Phase 1 study of High Grade B-Cell Lymphoma and B-Cell Non-Hodgkin Lymphoma that is active but no longer recruiting, run by University of Washington. The registered enrollment target is 23 participants, below the 61-participant average among 25 other High Grade B-Cell Lymphoma trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04257578, a Phase 1 study of High Grade B-Cell Lymphoma and B-Cell Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by University of Washington.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the safety of acalabrutinib and axicabtagene ciloleucel in treating patients with B-cell lymphoma. Acalabrutinib may stop the growth of tumor cells by blocking key pathways needed for cell growth. Immunotherapy with axicabtagene ciloleucel is engineered to target a specific surface antigen on lymphoma cells. Acalabrutinib may enhance the efficacy of axicabtagene ciloleucel in treating patients with B-cell lymphoma.
Primary Outcome
Toxicity as defined by the following: grade \>= 3 cytokine release syndrome, grade \>= 3 neurotoxicity within 30 days of infusion of axicabtagene ciloleucel. Grading will be done in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for neurotoxicity and the Lee Criteria for cytokine release syndrome, unless otherwise specified.
Conditions Studied
Interventions
- DRUG Acalabrutinib
- BIOLOGICAL Axicabtagene Ciloleucel
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2031-03-01 |
| Phase | Phase 1 |
What the registry record for NCT04257578 still lists
NCT04257578 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 61-participant average among 25 other High Grade B-Cell Lymphoma trials with a reported enrollment target (62% lower).
The record links to 8 conditions, with High Grade B-Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Acalabrutinib is the first listed.
NCT04257578 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT04257578 about?
NCT04257578 is a clinical study titled "Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma". This phase I/II trial studies the safety of acalabrutinib and axicabtagene ciloleucel in treating patients with B-cell lymphoma. Acalabrutinib may stop the growth of tumor cells by blocking key pathways needed for cell growth. Immunotherapy with axicabtagene ciloleucel is engineered to target a spec...
What is the current status of trial NCT04257578?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-12-02. Estimated completion is 2031-03-01.
What conditions does trial NCT04257578 study?
This clinical trial studies the following conditions: High Grade B-Cell Lymphoma, B-Cell Non-Hodgkin Lymphoma, Grade 3a Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Grade 1 Follicular Lymphoma.
What interventions are being tested in trial NCT04257578?
The interventions under investigation include: Acalabrutinib (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT04257578?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04257578 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04257578's enrollment target sits among peer trials
23 23rd of 25 higher than 3 of 25 other High Grade B-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade B-Cell 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.
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