Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma
Public ClinicalTrials.gov record NCT04432506. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pilot Study of Anakinra to Mitigate CAR-T Toxicity in Subjects With Relapsed or Refractory Large B-Cell Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04432506
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 22 participants
Conditions and interventions
Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent High Grade B-Cell Lymphoma
- Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
- Refractory Diffuse Large B-Cell Lymphoma
- Refractory High Grade B-Cell Lymphoma
- Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Interventions
- Anakinra Biological
- Axicabtagene Ciloleucel Biological
- Cyclophosphamide Drug
- Fludarabine Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 26, 2020
- Primary completion
- May 27, 2024
- Completion
- May 27, 2024
- Last update posted
- Jan 27, 2025
2020 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04432506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 27, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04432506 live on ClinicalTrials.gov.