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Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy

StatusRecruiting
PhasePhase 2
Started2023-05-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Jun 20, 2026 → Feb 2027
See other at-risk trials from H. Lee Moffitt Cancer Center and Research Institute

Amendment history

2026-09-17
Primary completion pushed: 2026-06-20 → 2027-02
2026-03-30
Study Status, Contacts/Locations v15
Study sitescontacts updated at 1 of 1 site
2026-02-25
Study Status v14
Primary completion date2026-01→2026-06-20
2026-01-06
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 1 site
2025-12-02
Study Status v12
Primary completion date2025-10→2026-01
Completion date2026-10→2027-01
Show 11 earlier versions
2025-09-29
Study Status v11
Re-verified, no change to tracked fields
2025-07-31
Study Status v10
Primary completion date2025-06→2025-10
Completion date2026-06→2026-10
2025-06-11
Study Status v9
Re-verified, no change to tracked fields
2025-03-12
Study Status v8
Primary completion date2025-04→2025-06
Completion date2026-04→2026-06
2024-12-10
Study Status v7
Primary completion date2024-12→2025-04
Completion date2025-12→2026-04
2024-08-23
Study Status v6
Primary completion date2024-10→2024-12
Completion date2026-11→2025-12
2024-06-04
Study Status v5
Primary completion date2024-06→2024-10
Completion date2026-05→2026-11
2024-02-09
Study Status v4
Primary completion date2028-02→2024-06
Completion date2028-02→2026-05
2023-10-17
Study Status v3
Re-verified, no change to tracked fields
2023-08-03
Study Status v2
Start date2023-02-23→2023-05-19
2023-03-06
Study Status, Study Description v1
Study description+12 characters
[...] infusion of axi-cel therapy will be administered on Day 0. WeInvestigators hypothesize that pre-modulation with itacitinib started app [...] oma (DLBCL) who express high levels of systemic inflammation.
2023-02-24
Original filing
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).
Trial Details
NCT Number NCT05757219
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Incyte Corporation
Conditions Diffuse Large B Cell Lymphoma
Enrollment 27 participants
Start Date 2023-05-19
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-16