CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Anakinra +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04432506
NCT04432506Phase 2Completed

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

M.D. Anderson Cancer Center·interventional·Posted Jun 16, 2020·Updated Jan 28, 2025

In Brief

A Phase 2 clinical trial evaluating Anakinra, Axicabtagene Ciloleucel, and 2 other interventions for Hematopoietic and Lymphoid Cell Neoplasm and 8 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 16, 2020
Enrollment StartJul 27, 2020
Primary CompletionMay 28, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.0 years ago

Interventions

Anakinrabiological

Given SC

Axicabtagene Ciloleucelbiological

Given IV

Cyclophosphamidedrug

Given IV

Fludarabinedrug

Given IV