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NCT05757219 · ClinicalTrials.gov registry record · Phase 2
Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy
A Phase 2 study of Diffuse Large B Cell Lymphoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT05757219: Recruiting Phase 2 study of Diffuse Large B Cell Lymphoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT05757219 is a Phase 2 study of Diffuse Large B Cell Lymphoma that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 27 participants, below the 218-participant average among 114 other Diffuse Large B Cell 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
NCT05757219, a Phase 2 study of Diffuse Large B Cell Lymphoma, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to assess the safety and efficacy of once daily itacitinib oral administration in participants with diffuse large B-cell lymphoma (DLBCL) who will receive CAR-T cell therapy with axicabtagene ciloleucel (axi-cel).
Primary Outcome
Progression Free Survival is defined as the time from start of treatment to the time of disease progression or death. Among patients treated with axi-cel who have a ferritin \>400 ng/ml and CRP\>2 mg/dl at the time of apheresis, the 6 month PFS was 25%. The primary endpoint of this study will be met if pre-modulation with itacitinib followed by axi-cel leads to a 6 month PFS of 45% or higher.
Conditions Studied
Interventions
- DRUG Itacitinib
- BIOLOGICAL Chimeric antigen receptor (CAR) T-cell therapy
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2023-05-19 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What NCT05757219 shows while recruiting
NCT05757219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Itacitinib is the first listed.
NCT05757219 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05757219 about?
NCT05757219 is a clinical study titled "Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy". The purpose of the study is to assess the safety and efficacy of once daily itacitinib oral administration in participants with diffuse large B-cell lymphoma (DLBCL) who will receive CAR-T cell therapy with axicabtagene ciloleucel (axi-cel).
What is the current status of trial NCT05757219?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2023-05-19. Estimated completion is 2027-01.
What conditions does trial NCT05757219 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma.
What interventions are being tested in trial NCT05757219?
The interventions under investigation include: Itacitinib (DRUG), Chimeric antigen receptor (CAR) T-cell therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT05757219?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05757219 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diffuse Large B Cell 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 NCT05757219's enrollment target sits among peer trials
27 84th of 114 higher than 29 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large 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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