Actively Recruiting
Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-31
27
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of diffuse large B-cell lymphoma (DLBCL) confirmed by tissue examination
- Age 18 years or older
- Able and willing to provide written informed consent
- Eligible for CAR-T cell therapy with axicabtagene ciloleucel (axi-cel) for DLBCL
- Serum ferritin level above 400 ng/mL and C-reactive protein level above 2 mg/dL (20 mg/L) at screening
- ECOG performance status of 0 to 2
- Women of childbearing potential and men must agree to use effective contraception during the study and safety follow-up
- Women of non-childbearing potential are eligible
- Not eligible for stem cell transplant due to active lymphoma
- Meet laboratory requirements as defined in the study protocol
You will not qualify if you...
- Received any investigational study drug within 4 weeks before screening
- Prior CAR-T cell therapy treatment
- Significant or uncontrolled heart disease, including recent heart attack or severe heart failure
- Unstable arrhythmias within 2 weeks before screening
- Active uncontrolled or untreated infections
- History of immune or autoimmune diseases affecting the central nervous system unrelated to lymphoma or prior treatment
- Known HIV infection
- Active or chronic hepatitis B infection without undetectable viral load on treatment
- History of hepatitis C infection unless cured
- Need for ongoing chronic systemic steroids or immunosuppressant drugs before leukapheresis
- Known allergy or severe reaction to itacitinib or similar drugs
- Unresolved side effects from prior cancer treatment greater than grade 1, except stable grade 2 peripheral neuropathy or any grade hair loss
- Pregnant or breastfeeding women
- Any condition that could interfere with participation or study procedures
- Unable to swallow and keep oral medication
- Taking strong CYP3A4 inhibitors or substances
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33617
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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