LymphomaPhase 1NCT04608487
Axi-cel in CNS Lymphoma
A Phase 1 study testing Fludarabine, Cyclophosphamide and Axicabtagene Ciloleucel in people with Lymphoma and Lymphoma Cns, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This research is being done to test the safety and effectiveness of axicabtagene ciloleucel (axi-cel), an anti-CD19 directed chimeric antigen receptor (CAR) T-cell therapy in treating relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, or systemic lymphoma with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Lymphoma Cns
- What is being tested?
- Fludarabine, Cyclophosphamide and Axicabtagene Ciloleucel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 2020to 14 Jun 2038
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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/refractory active primary or secondary CNS lymphoma, histologically proven aggressive B cell lymphoma, including DLBCL, HGBL, PMBL, or tFL, and defined by the following categories:
- Primary CNS lymphoma, relapsed or refractory following at least one line of CNS-directed therapy. There is no restriction on the number of recurrences.
- Secondary CNS lymphoma, relapsed or refractory following at least one line of CNS-directed therapy for prophylaxis or treatment of CNS lymphoma.
- Radiographically event CNS disease by MRI of the brain (ie enhancing lesion on gadolinium enhanced MRI)
- For patients with secondary CNSL with concurrent systemic lymphoma, the concurrent systemic lymphoma must be either DLBCL, PMBL, high grade B cell lymphoma, or transformed lymphoma and must have relapsed following at least 1 prior lines of therapy (which must have included an anti-CD20 monoclonal antibody (unless the tumor is CD20 negative) and an anthracycline
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent
Show all 19Show fewer
- Age 18 years or older at the time of informed consent
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal, hepatic, pulmonary and cardiac function defined as:
- Absolute neutrophil count (ANC) ≥1000/μL
- Platelet count ≥ 75,000/μL
- Absolute lymphocyte count ≥ 100/μL
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min
- Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome
- Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
- No clinically significant pleural effusion
- Baseline oxygen saturation > 92% on room air GCSF and transfusions are not allowed for eligibility determination.+++
- Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Who cannot join
- Primary vitreoretinal lymphoma and intraocular PCNSL without evidence of brain disease. Patients with prior history of intraocular involvement treated only with intraocular methotrexate and no prior systemic therapy are excluded
- PCNSL patients who cannot undergo magnetic resonance imaging assessments
- Patients with brain stem lesions
- Patients with leptomeningeal disease only without brain parenchymal involvement
- Bulky leptomeningeal disease and or CSF protein ≥100 mg/dL
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years
Show all 27Show fewer
- History of Richter's transformation of CLL
- History of allogeneic stem cell transplant
- Prior CD19 targeted therapy
- Treatment with systemic immunostimulatory agents (including but not limited to interferon and IL-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of axicabtagene ciloleucel or SOC
- Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
- History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
- Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
- Active tuberculosis
- History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12 months of enrollment
- Requirement for urgent therapy due to tumor mass effects
- History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 12 months.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed.
- History of symptomatic deep vein thrombosis or pulmonary embolism requiring ongoing systemic anticoagulation
- Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
- History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study
- Treatment with a live, attenuated vaccine within 6 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study
- Women of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of chemotherapy on the fetus or infant. Subjects of either sex who are not willing to practice birth control from the time of consent and at least 6 months after the last dose of axicabtagene ciloleucel or SOC chemotherapy
- In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: A Phase I Study of Anti-CD19 CAR T-cell Therapy With Axicabtagene Ciloleucel (Axi-cel) in Patients With Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphoma
This research is being done to test the safety and effectiveness of axicabtagene ciloleucel (axi-cel), an anti-CD19 directed chimeric antigen receptor (CAR) T-cell therapy in treating relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, or systemic lymphoma with a history of treated CNS lymphoma, and to better understand what causes neurological toxicity following treatment with axi-cel.
The names of the study drug(s) involved in this study are:
- axicabtagene ciloleucel (axi-cel)
- ludarabine will be given with axicel to help axicel work more effectively
- cyclophosphamide will be given with axicel to help axicel work more effectively
Read the detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. This study will examine the safety and efficacy of axi-cel in participants who either currently or previously had had central nervous system involvement of their lymphoma.
The name of the study drug involved in this study is axi-cel. Axi-cel is a chimeric antigen receptor (CAR) T-cell therapy that is manufactured using a person's own white blood cells. A virus is used to introduce a gene that creates a protein (called a CAR) on the surface of T cells, a type of blood cell that fights infection and can eliminate cancer cells. The CAR on the T cells may bind to and kill cells that express CD19, a molecule that is found on B-cell lymphomas. CAR-T cells (including axi-cel) designed to target CD19, a protein present on B lymphocytes have been used to treat patients with CD19+ tumors. This adoptive cell therapy (ACT) approach has shown significant and durable clinical benefits in the treatment of CD19+ tumors. Axi-cel has been FDA approved for the treatment of relapsed and refractory aggressive B cell lymphomas that occur outside the central nervous system and have recurred after two or more prior therapies.
Participants will receive two chemotherapy medicines, fludarabine and cyclophosphamide. These drugs are not intended as direct cancer treatment but instead to help axi-cel work with less interference from immune system cells.
The research study procedures include screening for eligibility and study treatment including leukapheresis, evaluations and follow up visits.
Participants will receive study treatment once and will be followed for up to 15 years.
It is expected that about 18 people will take part in this research study.
Kite Pharma, a pharmaceutical company, is supporting this research study by providing axi-cel.
- Conditions
- Lymphoma, Lymphoma Cns
- Being tested
- Fludarabine, Cyclophosphamide, Axicabtagene Ciloleucel
- Keywords
- relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, systemic lymphoma with a history of treated CNS lymphoma
- Medical subject headings
- Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Also called Fludara
Intravenous infusion
CyclophosphamideDrug
Also called Cytoxan, Neosar
Intravenous infusion
Axicabtagene CiloleucelBiological
Also called Yescarta
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine + Cyclophosphamide + Axicabtagene Ciloleucel | Experimental | Prior to receiving axi-cel, participants will undergo leukapheresis and the need for a Ommaya reservoir placement will be assessed and administered.
Day -5 to Day -3 of 28 day study cycle Fludarabine and cyclophosphamide; Day -1 admitted to hospital, receive axi-cel on day 0; Till at least cycle day 7 hospital monitoring; post treatment follow up will occur on day 14 and day 28 of cycle 1, monthly in cycles 2, 3, 6, 9,12,15,18,21,24, then yearly after cycle 24. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: Axicabtagene Ciloleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Measured by the rate of TLTs and the rate of grade 3+ adverse events (AEs) regardless of attribution
Measured: Enrollment until 30 days after last dose of study treatment up to 24 Months
Secondary outcomes (5)
Objective response rate (ORR)
CNS lymphoma response assessment will be evaluated by International Primary CNS Lymphoma Collaborative Group (IPCG) criteria Systemic lymphoma response assessment will be evaluated by the Lugano 2014 criteria
Measured: 2 years
Complete response (CR) rate
CNS lymphoma response assessment will be evaluated by International Primary CNS Lymphoma Collaborative Group (IPCG) criteria Systemic lymphoma response assessment will be evaluated by the Lugano 2014 criteria
Measured: 2 years
Duration of response (DOR)
CNS lymphoma response assessment will be evaluated by International Primary CNS Lymphoma Collaborative Group (IPCG) criteria Systemic lymphoma response assessment will be evaluated by the Lugano 2014 criteria
Measured: 2 years
Progression-free survival (PFS)
CNS lymphoma response assessment will be evaluated by International Primary CNS Lymphoma Collaborative Group (IPCG) criteria Systemic lymphoma response assessment will be evaluated by the Lugano 2014 criteria
Measured: 2 years
Overall survival (OS)
CNS lymphoma response assessment will be evaluated by International Primary CNS Lymphoma Collaborative Group (IPCG) criteria Systemic lymphoma response assessment will be evaluated by the Lugano 2014 criteria
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start4 Dec 2020
- Primary completion14 Jun 2025
- Study completion14 Jun 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kite, A Gilead Company
- Responsible party
- Principal investigator, Caron A. Jacobson, MD, Dana-Farber Cancer Institute
- Investigators
- Caron Jacobson, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608487
- Sponsor's protocol ID
- 20-274
- Status last verified
- Aug 2026
- First submitted
- 19 Oct 2020
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: the Sponsor Investigator, Dr. Caron Jacobson. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Anti-CD19 CAR T-cell Therapy With Axicabtagene Ciloleucel (Axi-cel) in Patients With Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphoma
- ClinicalTrials.gov ID
- NCT04608487
- Acronym / sponsor ID
- 20-274
- Conditions
- Lymphoma, Lymphoma Cns
- Keywords
- relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, systemic lymphoma with a history of treated CNS lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Kite, A Gilead Company
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 14 Jun 2025 (actual)
- Study completion
- 14 Jun 2038 (estimated)
- First posted
- 29 Oct 2020 (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 research is being done to test the safety and effectiveness of axicabtagene ciloleucel (axi-cel), an anti-CD19 directed chimeric antigen receptor (CAR) T-cell therapy in treating relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, or systemic lymphoma with a history of treated CNS lymphoma, and to better understand what causes neurological toxicity following treatment with axi-cel.
The names of the study drug(s) involved in this study are:
- axicabtagene ciloleucel (axi-cel)
- ludarabine will be given with axicel to help axicel work more effectively
- cyclophosphamide will be given with axicel to help axicel work more effectively
Detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. This study will examine the safety and efficacy of axi-cel in participants who either currently or previously had had central nervous system involvement of their lymphoma.
The name of the study drug involved in this study is axi-cel. Axi-cel is a chimeric antigen receptor (CAR) T-cell therapy that is manufactured using a person's own white blood cells. A virus is used to introduce a gene that creates a protein (called a CAR) on the surface of T cells, a type of blood cell that fights infection and can eliminate cancer cells. The CAR on the T cells may bind to and kill cells that express CD19, a molecule that is found on B-cell lymphomas. CAR-T cells (including axi-cel) designed to target CD19, a protein present on B lymphocytes have been used to treat patients with CD19+ tumors. This adoptive cell therapy (ACT) approach has shown significant and durable clinical benefits in the treatment of CD19+ tumors. Axi-cel has been FDA approved for the treatment of relapsed and refractory aggressive B cell lymphomas that occur outside the central nervous system and have recurred after two or more prior therapies.
Participants will receive two chemotherapy medicines, fludarabine and cyclophosphamide. These drugs are not intended as direct cancer treatment but instead to help axi-cel work with less interference from immune system cells.
The research study procedures include screening for eligibility and study treatment including leukapheresis, evaluations and follow up visits.
Participants will receive study treatment once and will be followed for up to 15 years.
It is expected that about 18 people will take part in this research study.
Kite Pharma, a pharmaceutical company, is supporting this research study by providing axi-cel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fludarabine + Cyclophosphamide + Axicabtagene Ciloleucel | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: Axicabtagene CiloleucelPrior to receiving axi-cel, participants will undergo leukapheresis and the need for a Ommaya reservoir placement will be assessed and administered. Day -5 to Day -3 of 28 day study cycle Fludarabine and cyclophosphamide; Day -1 admitted to hospital, receive axi-cel on day 0; Till at least cycle day 7 hospital monitoring; post treatment follow up will occur on day 14 and day 28 of cycle 1, monthly in cycles 2, 3, 6, 9,12,15,18,21,24, then yearly after cycle 24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with relapsed/refractory active primary or secondary CNS lymphoma, histologically proven aggressive B cell lymphoma, including DLBCL, HGBL, PMBL, or tFL, and defined by the following categories:
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent
- Age 18 years or older at the time of informed consent
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal, hepatic, pulmonary and cardiac function defined as:
Key exclusion criteria (27 listed)
- Primary vitreoretinal lymphoma and intraocular PCNSL without evidence of brain disease. Patients with prior history of intraocular involvement treated only with intraocular methotrexate and no prior systemic therapy are excluded
- PCNSL patients who cannot undergo magnetic resonance imaging assessments
- Patients with brain stem lesions
- Patients with leptomeningeal disease only without brain parenchymal involvement
- Bulky leptomeningeal disease and or CSF protein ≥100 mg/dL
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 |
|---|---|---|
| FludarabineAlso: FludaraIntravenous infusion | Drug | Fludarabine + Cyclophosphamide + Axicabtagene Ciloleucel |
| CyclophosphamideAlso: Cytoxan, NeosarIntravenous infusion | Drug | Fludarabine + Cyclophosphamide + Axicabtagene Ciloleucel |
| Axicabtagene CiloleucelAlso: YescartaIntravenous infusion | Biological | Fludarabine + Cyclophosphamide + Axicabtagene Ciloleucel |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Time frame: Enrollment until 30 days after last dose of study treatment up to 24 Months
Measured by the rate of TLTs and the rate of grade 3+ adverse events (AEs) regardless of attribution
5 secondary outcomes
Objective response rate (ORR)
Time frame: 2 years
Complete response (CR) rate
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: the Sponsor Investigator, Dr. Caron Jacobson. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Caron Jacobson, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fludarabine, Cyclophosphamide and Axicabtagene Ciloleucel in people with Lymphoma and Lymphoma Cns, run by Dana-Farber Cancer Institute 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 19 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 (time frame: Enrollment until 30 days after last dose of study treatment up to 24 Months). 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 12 Aug 2026.