Study on Itacitinib Before CAR-T Cell Therapy for Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05757219

Provider View

This clinical trial is testing the safety and effectiveness of taking the drug itacitinib before receiving CAR-T cell therapy in patients with diffuse large B-cell lymphoma (DLBCL) who have high levels of inflammation.

Patient Parameters

Program Overview

The study aims to find out if taking itacitinib, a medication taken by mouth once a day, can help improve outcomes for patients with diffuse large B-cell lymphoma (DLBCL) who are receiving CAR-T cell therapy. The trial involves about 27 adults who will be treated at the Moffitt Cancer Center. Participants must have high levels of certain inflammation markers in their blood. The treatment with itacitinib will start about 4-6 weeks before the CAR-T cell therapy and continue until 30 days after the therapy. The researchers believe that starting itacitinib before the CAR-T cell therapy may help improve patient outcomes.

Description

This study is a Phase 2 trial, meaning it focuses on evaluating the safety and effectiveness of a treatment. It is a single-arm, open-label study, which means all participants will receive the same treatment, and both the researchers and participants know what treatment is being given. The study is for adults with diffuse large B-cell lymphoma (DLBCL) who will receive CAR-T cell therapy with a drug called axicabtagene ciloleucel (Axi-cel). Participants must have high levels of inflammation markers, specifically ferritin and C-reactive protein (CRP), in their blood. The treatment involves taking itacitinib, a pill, once a day starting about 4-6 weeks before the CAR-T cell therapy and continuing until 30 days after the therapy. The exact timing may vary depending on the preparation of the CAR-T cells. The goal is to see if this approach can improve outcomes for patients with DLBCL who have high inflammation levels.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) who plan to receive treatment at the Moffitt Cancer Center.
  • Eligible to receive CAR-T cell therapy (axicabtagene ciloleucel) for DLBCL.
  • High levels of inflammation markers: ferritin above 400 mg/mL and C-reactive protein above 2 mg/dL (20 mg/L).
  • Good overall health with an ECOG performance status of 0 to 2.
  • Must agree to use effective birth control methods during the study and for a specified time after.
  • Ineligible for stem cell transplant due to active lymphoma.
  • Must meet specific laboratory test requirements at screening.

Exclusion Criteria

  • Recent use of any investigational study agent within 4 weeks before screening.
  • Previous treatment with CAR-T cell therapy.
  • Significant or uncontrolled heart disease or arrhythmias.
  • Active, uncontrolled infections.
  • History of certain immune or inflammatory diseases affecting the central nervous system.
  • Positive for HIV or active hepatitis B or C infections.
  • Need for chronic systemic steroids or immunosuppressants.
  • Known allergy to itacitinib or similar compounds.
  • Not fully recovered from side effects of previous cancer treatments.
  • Pregnant or breastfeeding women.
  • Any condition that might interfere with participation or pose a risk to the participant.
  • Inability to swallow pills.
  • Use of strong inhibitors of CYP3A4 enzyme.

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