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NCT04608487 · ClinicalTrials.gov registry record · Phase 1
Axi-cel in CNS Lymphoma
A Phase 1 study of Lymphoma and Lymphoma Cns, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT04608487: Active Phase 1 study of Lymphoma and Lymphoma Cns, sponsored by Dana-Farber Cancer Institute.
NCT04608487 is a Phase 1 study of Lymphoma and Lymphoma Cns that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 18 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04608487, a Phase 1 study of Lymphoma and Lymphoma Cns, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research is being done to test the safety and effectiveness of axicabtagene ciloleucel (axi-cel), an anti-CD19 directed chimeric antigen receptor (CAR) T-cell therapy in treating relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, or systemic lymphoma with a history of treated CNS lymphoma, and to better understand what causes neurological toxicity following treatment with axi-cel. The names of the study drug(s) involved in this study are: * axicabtagene ciloleucel (axi-cel) * ludarabine will be given with axicel to help axicel work more effectively * cyclophosphamide will be given with axicel to help axicel work more effectively
Primary Outcome
Measured by the rate of TLTs and the rate of grade 3+ adverse events (AEs) regardless of attribution
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Axicabtagene Ciloleucel
Study Locations (2)
Massachusetts
- Dana Farber Cancer Institute - Boston
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-12-04 |
| Est. Completion | 2038-06-14 |
| Phase | Phase 1 |
What the registry record for NCT04608487 still lists
NCT04608487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT04608487 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04608487 about?
NCT04608487 is a clinical study titled "Axi-cel in CNS Lymphoma". This research is being done to test the safety and effectiveness of axicabtagene ciloleucel (axi-cel), an anti-CD19 directed chimeric antigen receptor (CAR) T-cell therapy in treating relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, or system...
What is the current status of trial NCT04608487?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-12-04. Estimated completion is 2038-06-14.
What conditions does trial NCT04608487 study?
This clinical trial studies the following conditions: Lymphoma, Lymphoma Cns.
What interventions are being tested in trial NCT04608487?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT04608487?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04608487 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04608487's enrollment target sits among peer trials
18 255th of 299 higher than 43 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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