Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedPhase 2NCT04205838
Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma
A Phase 2 study testing Anakinra, Axicabtagene Ciloleucel and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, Not Otherwise Specified and High Grade B-Cell Lymphoma, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This phase II trial studies how well anakinra works in preventing severe chimeric antigen receptor T-cell-related encephalopathy syndrome after chimeric antigen receptor T-cell therapy in patients with large B-cell lymphoma that has come back or has not responded to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma, Progressive Disease
- What is being tested?
- Anakinra, Axicabtagene Ciloleucel and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Mar 2020to 19 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with relapsed or refractory large B-cell lymphoma that has progressed on two prior lines of therapy, who meet the indication for the Food and Drug Administration (FDA)-approved therapy axicabtagene ciloleucel
- Large B-cell lymphoma includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
- The above includes patients with progressive or stable disease as the best response to the most recent treatment regimen or disease progression within 12 months after autologous hematopoietic stem cell transplantation
- Patients with central nervous system (CNS) involvement of large B-cell lymphoma that originated outside of the CNS will be included (not primary CNS lymphoma)
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 2.5 upper limit of normal
- Total bilirubin =< 2.0 mg/dL
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- Creatinine clearance > 30 mL/min based on Cockcroft-Gault formula
- Patients with human immunodeficiency virus (HIV) who have an undetectable viral load will be included
- Deemed competent to make medical decisions
Who cannot join
- Patients who receive CAR T-cell therapy with a product other than axicabtagene ciloleucel
- Primary CNS lymphoma
- Transformed DLBCL from chronic lymphocytic leukemia (CLL)
- Burkitt?s lymphoma
- Bridging chemotherapy completed < 7 days prior to CAR T-cell lymphodepleting chemotherapy
- In patients who receive bridging chemotherapy, positron emission tomography (PET)-computed tomography (CT) or CT of chest, abdomen, pelvis was not done after bridging chemotherapy prior lympho-depleting therapy
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- Most recent PET-CT or CT of all known disease is sites done more than 6 weeks prior to CAR T-cell infusion
- Any individual CNS tumor mass > 2 cm
- History of autologous hematopoietic stem cell transplantation administered less than 100 days prior to CAR T-cell infusion
- History of allogeneic hematopoietic stem cell transplantation
- Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
- Less than 3 half-lives elapsed since receiving immune checkpoint inhibitor (pembrolizumab, ipilimumab, nivolumab, atezolizumab, etc.)
- Presence of uncontrolled fungal, bacterial, or viral infection that require intravenous (IV) antimicrobial treatment
- History of autoimmune disease resulting in end-organ damage, or autoimmune disease requiring systemic immunosuppressants or disease-modifying antirheumatic drug (DMARDs) within the past 6 months
- Hypersensitivity to E. Coli-derived proteins
- Patients with HIV who have a detectable viral load
- Pregnant or nursing
- Fertile women who decline use of contraception during the study period
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC Davis Comprehensive Cancer Center
Davis, California, 95817
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: IL-1 Receptor Antagonist to Prevent Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome
This phase II trial studies how well anakinra works in preventing severe chimeric antigen receptor T-cell-related encephalopathy syndrome after chimeric antigen receptor T-cell therapy in patients with large B-cell lymphoma that has come back or has not responded to treatment. Immunosuppressive therapy, such as anakinra, is used to decrease the body?s immune response, which may prevent severe chimeric antigen receptor T-cell-related encephalopathy syndrome.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if it is feasible to accrue a sufficient number of study participants at one site, in order to justify expanding the trial to three additional sites (pilot study).
II. To estimate the efficacy of anakinra in prevention of severe immune effector cell-associated neurotoxicity syndrome. syndrome (ICANS) (full study).
SECONDARY OBJECTIVES:
- To estimate the impact that anakinra has on the efficacy of chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory lymphoma.
II. To estimate the rate of subsequent ICANS development in patients who receive anakinra for grade >= 3 cytokine release syndrome (CRS) in the absence of ICANS.
III. To estimate the duration of neurotoxicity in patients who receive anakinra.
IV. To estimate the duration of severe neurotoxicity in patients who receive anakinra.
- To determine if anakinra causes persistent hepatotoxicity in patients receiving CAR T-cell for refractory lymphoma.
VI. to evaluate the overall toxicity of anakinra in patients receiving CAR T-cell therapy for refractory lymphoma.
EXPLORATORY OBJECTIVES:
- To evaluate CRS and ICANS grade by using the American Society for Blood and Marrow Transplantation (ASBMT) 2018 consensus grading for adults.
II. To investigate changes in inflammatory markers including IL-1 and IL-6 in the peripheral blood during episodes of ICANS.
III. To describe the electroencephalogram (EEG) changes that characterize ICANS.
OUTLINE:
Patients receive standard lymphodepleting therapy including fludarabine and cyclophosphamide on days -5 to -3, then receive axicabtagene ciloleucel CAR T-cell infusion. Patients with clinical evidence of ICANS of any grade, or CRS >= grade 3 receive anakinra subcutaneously (SC) every 6-12 hours for 12-36 doses over 9 days in the absence of unacceptable toxicity.
After completion of study, patients are followed up at 30, 90, and 100 days, then at 6 months.
- Conditions
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma, Progressive Disease, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent High Grade B-Cell Lymphoma, Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
- Being tested
- Anakinra, Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Fludarabine Phosphate
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraBiological
Also called Kinaret, Kineret, rIL-1ra, rIL1RN
Given SC
Axicabtagene CiloleucelBiological
Also called KTE C19, KTE-C19, KTE-C19 CAR, Yescarta
Given via infusion
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida
Given via infusion
FludarabineDrug
Also called Fluradosa
Given via infusion
Also called 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara
Given via infusion
| Study group | Role | What they receive |
|---|---|---|
| Prevention (anakinra, CAR T-cell therapy) | Experimental | Patients receive standard lymphodepleting therapy including fludarabine and cyclophosphamide on days -5 to -3, then receive axicabtagene ciloleucel CAR T-cell infusion. Patients with clinical evidence of ICANS of any grade, or CRS >= grade 3 receive anakinra SC every 6-12 hours for 12-36 doses over 9 days in the absence of unacceptable toxicity. Receives: Biological: Anakinra; Biological: Axicabtagene Ciloleucel; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Fludarabine Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who met the eligibility criteria to receive and did receive anakinra
The study will be considered feasible if 8 study participants are enrolled over 12 months at University of California, Los Angeles.
Measured: Up to 12 months
Rate of severe chimeric antigen receptor T-cell-related encephalopathy syndrome (ICANS)
Will be defined as grade >= 3 neurotoxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03. The proportion of patients developing severe ICANS and the corresponding 90% binomial exact confidence interval (CI) will be reported.
Measured: Up to 30 days
Secondary outcomes (6)
Objective response rate (ORR)
Will be defined as a complete response or partial response per the International Working Group criteria malignancy lymphoma based on positron emission tomography (PET)/computed tomography (CT) scan. To account for the adaptive nature of Simon?s two-stage design, final analysis of the objective response rate will report the uniformly minimum variance unbiased estimator and the corresponding p-value and 95% CI for the ORR.
Measured: Up to 90 days
Proportion of patients who received anakinra and develop ICAN
The proportion of patients who received anakinra in the absence of ICANS and then develop ICANS of any grade out of the total number of participants who received anakinra in the absence of ICANS will be evaluated. Will be summarized using descriptive statistics such as proportion, mean, standard deviation, median, as appropriate.
Measured: Up to 30 days
Duration of neurotoxicity
Defined as number of days that elapse from first day of ICANS of any grade to complete resolution of ICANS. Will be summarized using descriptive statistics such as proportion, mean, standard deviation, median, as appropriate.
Measured: From first day of CRES of any grade to complete resolution of CRES, assessed up to 100 days
Duration of neurotoxicity
Defined as number of days that elapse from first day of ICANS of >= grade 3 to improvement of ICANS to < grade 3 based on CTCAE v4.03. Will be summarized using descriptive statistics such as proportion, mean, standard deviation, median, as appropriate.
Measured: From first day of ICANS of >= grade 3 to improvement of ICANS to < grade 3, assessed up to 100 days
Persistent hepatotoxicity
Will be defined as grade > 2 aspartate aminotransferase (AST)/alanine aminotransferase (ALT) increased for at least 4 weeks duration according to CTCAE v4.03. Will be summarized using descriptive statistics such as proportion, mean, standard deviation, median, as appropriate.
Measured: Up to 100 days
Incidence of adverse events (AEs)
Will be based on CTCAE v4.03. Will be summarized using descriptive statistics such as proportion, mean, standard deviation, median, as appropriate. All AEs will be listed, documenting the course, outcome, severity, and relationship to the study treatment. Incidence rates of AEs and the proportion of subjects prematurely withdrawn from the study due to AEs will be shown.
Measured: Up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start4 Mar 2020
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John M Timmerman, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205838
- Sponsor's protocol ID
- 19-000604
- Other IDs
- NCI-2019-02887, 19-000604
- Status last verified
- Jul 2025
- First submitted
- 2 Oct 2019
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL-1 Receptor Antagonist to Prevent Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome
- ClinicalTrials.gov ID
- NCT04205838
- Acronym / sponsor ID
- 19-000604
- Conditions
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma, Progressive Disease, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent High Grade B-Cell Lymphoma, Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well anakinra works in preventing severe chimeric antigen receptor T-cell-related encephalopathy syndrome after chimeric antigen receptor T-cell therapy in patients with large B-cell lymphoma that has come back or has not responded to treatment. Immunosuppressive therapy, such as anakinra, is used to decrease the body?s immune response, which may prevent severe chimeric antigen receptor T-cell-related encephalopathy syndrome.
Detailed description
PRIMARY OBJECTIVES:
- To determine if it is feasible to accrue a sufficient number of study participants at one site, in order to justify expanding the trial to three additional sites (pilot study).
II. To estimate the efficacy of anakinra in prevention of severe immune effector cell-associated neurotoxicity syndrome. syndrome (ICANS) (full study).
SECONDARY OBJECTIVES:
- To estimate the impact that anakinra has on the efficacy of chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory lymphoma.
II. To estimate the rate of subsequent ICANS development in patients who receive anakinra for grade >= 3 cytokine release syndrome (CRS) in the absence of ICANS.
III. To estimate the duration of neurotoxicity in patients who receive anakinra.
IV. To estimate the duration of severe neurotoxicity in patients who receive anakinra.
- To determine if anakinra causes persistent hepatotoxicity in patients receiving CAR T-cell for refractory lymphoma.
VI. to evaluate the overall toxicity of anakinra in patients receiving CAR T-cell therapy for refractory lymphoma.
EXPLORATORY OBJECTIVES:
- To evaluate CRS and ICANS grade by using the American Society for Blood and Marrow Transplantation (ASBMT) 2018 consensus grading for adults.
II. To investigate changes in inflammatory markers including IL-1 and IL-6 in the peripheral blood during episodes of ICANS.
III. To describe the electroencephalogram (EEG) changes that characterize ICANS.
OUTLINE:
Patients receive standard lymphodepleting therapy including fludarabine and cyclophosphamide on days -5 to -3, then receive axicabtagene ciloleucel CAR T-cell infusion. Patients with clinical evidence of ICANS of any grade, or CRS >= grade 3 receive anakinra subcutaneously (SC) every 6-12 hours for 12-36 doses over 9 days in the absence of unacceptable toxicity.
After completion of study, patients are followed up at 30, 90, and 100 days, then at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (anakinra, CAR T-cell therapy) | Experimental | Biological: Anakinra, Biological: Axicabtagene Ciloleucel, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Fludarabine PhosphatePatients receive standard lymphodepleting therapy including fludarabine and cyclophosphamide on days -5 to -3, then receive axicabtagene ciloleucel CAR T-cell infusion. Patients with clinical evidence of ICANS of any grade, or CRS >= grade 3 receive anakinra SC every 6-12 hours for 12-36 doses over 9 days in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with relapsed or refractory large B-cell lymphoma that has progressed on two prior lines of therapy, who meet the indication for the Food and Drug Administration (FDA)-approved therapy axicabtagene ciloleucel
- Large B-cell lymphoma includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
- The above includes patients with progressive or stable disease as the best response to the most recent treatment regimen or disease progression within 12 months after autologous hematopoietic stem cell transplantation
- Patients with central nervous system (CNS) involvement of large B-cell lymphoma that originated outside of the CNS will be included (not primary CNS lymphoma)
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 2.5 upper limit of normal
Key exclusion criteria (18 listed)
- Patients who receive CAR T-cell therapy with a product other than axicabtagene ciloleucel
- Primary CNS lymphoma
- Transformed DLBCL from chronic lymphocytic leukemia (CLL)
- Burkitt?s lymphoma
- Bridging chemotherapy completed < 7 days prior to CAR T-cell lymphodepleting chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnakinraAlso: Kinaret, Kineret, rIL-1ra, rIL1RNGiven SC | Biological | Prevention (anakinra, CAR T-cell therapy) |
| Axicabtagene CiloleucelAlso: KTE C19, KTE-C19, KTE-C19 CAR, YescartaGiven via infusion | Biological | Prevention (anakinra, CAR T-cell therapy) |
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, CiclofosfamidaGiven via infusion | Drug | Prevention (anakinra, CAR T-cell therapy) |
| FludarabineAlso: FluradosaGiven via infusion | Drug | Prevention (anakinra, CAR T-cell therapy) |
| Fludarabine PhosphateAlso: 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, FludaraGiven via infusion | Drug | Prevention (anakinra, CAR T-cell therapy) |
Primary outcome
Number of patients who met the eligibility criteria to receive and did receive anakinra
Time frame: Up to 12 months
The study will be considered feasible if 8 study participants are enrolled over 12 months at University of California, Los Angeles.
Rate of severe chimeric antigen receptor T-cell-related encephalopathy syndrome (ICANS)
Time frame: Up to 30 days
Will be defined as grade >= 3 neurotoxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03. The proportion of patients developing severe ICANS and the corresponding 90% binomial exact confidence interval (CI) will be reported.
6 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 90 days
Proportion of patients who received anakinra and develop ICAN
Time frame: Up to 30 days
Duration of neurotoxicity
Time frame: From first day of CRES of any grade to complete resolution of CRES, assessed up to 100 days
Duration of neurotoxicity
Time frame: From first day of ICANS of >= grade 3 to improvement of ICANS to < grade 3, assessed up to 100 days
Persistent hepatotoxicity
Time frame: Up to 100 days
Incidence of adverse events (AEs)
Time frame: Up to 100 days
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Timmerman, MD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra, Axicabtagene Ciloleucel and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, Not Otherwise Specified and High Grade B-Cell Lymphoma, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who met the eligibility criteria to receive and did receive anakinra (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.