Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05757219
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    Participants start itacitinib 200 mg PO once daily within 1-4 days after apheresis while awaiting CAR-T-cell manufacturing, which is expected to take approximately from week -4 until day -7. Patients will remain on itacitinib 200 mg PO once daily from initiation until 30 days post-CAR-T-cell therapy (Day 30) including throughout lymphodepleting chemotherapy period (Days -5, -4, -3) and axi-cel infusion (Day 0) for a total of approximately 58 doses.
  • Chimeric antigen receptor (CAR) T-cell therapy — BIOLOGICAL
    Yescarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help the T cells recognize cancer cells. The reengineered T cells are infused back into the patient to attack the cancer.

Study Details

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).

Key Dates

Start date
May 19, 2023
Status verified
Mar 2026
Primary completion
Jun 20, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-Modulation Treatment
    Participants will receive itacitinib 200 mg PO QD beginning at time of apheresis approximately 4-6 weeks prior to CAR-T-cell therapy and will continue until Day 30 (30 Days Post-CAR-T-cell therapy)

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: at 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33617
Kelsey Lee
[email protected]
813-745-8228
Michael Jain, MD, PhD (PRINCIPAL_INVESTIGATOR)
Julio Chavez, MD, MS (SUB_INVESTIGATOR)
Rawan Faramand, MD (SUB_INVESTIGATOR)
Farhad Khimani, MD (SUB_INVESTIGATOR)
Aleksandr Lazaryan, MD, MPH, PhD (SUB_INVESTIGATOR)
Hien Liu, MD (SUB_INVESTIGATOR)
Frederick Locke, MD (SUB_INVESTIGATOR)
Taiga Nishihori, MD (SUB_INVESTIGATOR)
Javier Pinilla, MD, PhD (SUB_INVESTIGATOR)
Bijal Shah, MD, MS (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FL

Related Studies