Trials / Completed

CompletedNCT04432506

Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma

Pilot Study of Anakinra to Mitigate CAR-T Toxicity in Subjects With Relapsed or Refractory Large B-Cell Lymphoma

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 22 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and best dose of anakinra and to see how well it works in reducing side effects (toxicity) associated with a CAR-T cell treatment called axicabtagene ciloleucel in patients with large B-cell lymphoma that has come back (relapsed) or has not responded to treatment (refractory). Anakinra is a drug typically used to treat rheumatoid arthritis but may also help in reducing CAR-T cell therapy toxicity. Giving anakinra in combination with axicabtagene ciloleucel may help control relapsed or refractory large B-cell lymphoma.

Detailed description

PRIMARY OBJECTIVE: I. To assess safety and tolerability of anakinra in reducing incidence of cytokine release syndrome (CRS) within 30 days after infusion of chimeric antigen receptor (CAR) T cells in subjects with relapsed or refractory large B-cell lymphoma. SECONDARY OBJECTIVES: I. To determine incidence of all grades and duration of both CRS and immune-cell associated neurotoxicity syndrome (ICANS). II. To determine the complete response rate (CRR), overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). EXPLORATORY OBJECTIVES: I. To determine the effects of anakinra on the cytokine and chemokine profile in peripheral blood after CAR-T therapy. II. To determine the effects of anakinra on the expansion and persistence of CAR T cells. III. To correlate baseline characteristics with toxicity, response and survival after anakinra combined with CAR-T therapy. OUTLINE: This is a dose-escalation study of anakinra. Patients receive cyclophosphamide intravenously (IV) over 60 minutes and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive axicabtagene ciloleucel IV over 30 minutes or less on day 0 and anakinra subcutaneously (SC) on days 0-6 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 2 and 4 weeks, and then at 2, 3, 6, 9, 12, 18, and 24 months.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	Anakinra	Given SC
BIOLOGICAL	Axicabtagene Ciloleucel	Given IV
DRUG	Cyclophosphamide	Given IV
DRUG	Fludarabine	Given IV

Timeline

Start date: 2020-07-27
Primary completion: 2024-05-28
Completion: 2024-05-28
First posted: 2020-06-16
Last updated: 2025-01-28
Results posted: 2025-01-28

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04432506. Inclusion in this directory is not an endorsement.