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CAR T-cell Therapy
CAR T-Cell Therapy for Central Nervous System Lymphoma
Phase 1
Waitlist Available
Led By Caron Jacobson, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary CNS lymphoma, relapsed or refractory following at least one line of CNS-directed therapy. There is no restriction on the number of recurrences.
Age 18 years or older at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is being done to test the safety and effectiveness of axicabtagene ciloleucel, 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. The trial will also assess neurological toxicity following treatment with axi-cel.
Who is the study for?
Adults over 18 with relapsed/refractory central nervous system (CNS) lymphoma or systemic lymphoma with CNS involvement, who've had at least one prior treatment. They must have adequate organ function, no severe infections, and not be pregnant or breastfeeding. Excluded are those with certain heart conditions, active infections requiring IV treatment, history of other cancers within 3 years (except some skin cancers), and those unable to undergo MRI.Check my eligibility
What is being tested?
The trial is testing axicabtagene ciloleucel (axi-cel), a CAR T-cell therapy targeting CD19 in patients with specific types of CNS lymphomas that have returned after treatment. It includes pre-treatment drugs cyclophosphamide and fludarabine to enhance the effectiveness of axi-cel.See study design
What are the potential side effects?
Potential side effects include neurological toxicity which can affect brain function, immune reactions causing inflammation in various organs including the heart and lungs, blood cell count changes leading to increased infection risk or bleeding problems, fatigue, allergic reactions to infusion components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain lymphoma has returned or didn't respond after treatment.
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I am 18 years old or older.
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My lymphoma is aggressive and has come back or didn't respond to treatment.
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My CNS lymphoma has returned or didn't respond after treatment.
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I am fully active or can carry out light work.
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My heart pumps well, and I have no serious heart fluid buildup or ECG issues.
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My kidneys are functioning well.
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I do not have serious fluid buildup in my chest.
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My oxygen level is above 92% without assistance, and I haven't used GCSF or transfusions for this condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Secondary outcome measures
Complete response (CR) rate
Duration of response (DOR)
Objective response rate (ORR)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Fludarabine + Cyclophosphamide + Axicabtagene CiloleucelExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Axicabtagene ciloleucel
FDA approved
Fludarabine
FDA approved
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,854 Total Patients Enrolled
4 Trials studying Central Nervous System Lymphoma
137 Patients Enrolled for Central Nervous System Lymphoma
Kite, A Gilead CompanyIndustry Sponsor
43 Previous Clinical Trials
3,633 Total Patients Enrolled
Caron Jacobson, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lymphoma in my eye but no brain disease, and haven't had systemic therapy.I have a history of serious brain or nerve conditions.My brain lymphoma has returned or didn't respond after treatment.I am 18 years old or older.My lymphoma is aggressive and has come back or didn't respond to treatment.I have a lesion in my brain stem.I have had CAR-T cell therapy or other genetic modifications to my T-cells.I haven't had major heart issues or treatments in the last year.My lymphoma has returned after treatment including an anti-CD20 drug and an anthracycline.I am not pregnant or breastfeeding and willing to use birth control during and 6 months after treatment.You have had a serious allergic reaction in the past to tocilizumab or any of the other medications being used in this study.My CNS lymphoma has returned or didn't respond after treatment.I have had a stem cell transplant from a donor.I have previously received treatment targeting CD19.I have a significant brain or spinal cord tumor or my CSF protein is high.I have been cancer-free for 3 years, except for non-dangerous skin cancers or early-stage cancers.I haven't taken any immune-boosting drugs in the last 6 weeks or before their effects wore off.I have HIV or hepatitis B/C, but if treated, my viral load is undetectable.I cannot have MRI scans due to my condition.My CLL has transformed into a more aggressive form.I do not have any serious infections, or if I do, they are under control with treatment.I have active tuberculosis.My lymphoma affects my heart's atrium or ventricle.I need urgent treatment because my tumor is causing symptoms.I am on blood thinners due to a serious clot in my veins or lungs.I have not received a live vaccine in the last 6 weeks and do not plan to during the study.It's been over 2 weeks or 5 half-lives since my last cancer treatment.My cancer has spread to the lining of my brain and spinal cord but not into the brain tissue itself.I have an autoimmune disease and have been on systemic treatment in the past year.I have a history of lung scarring or inflammation but not from radiation.I don't have any health issues that could affect the study's safety or results.I am fully active or can carry out light work.My heart pumps well, and I have no serious heart fluid buildup or ECG issues.My kidneys are functioning well.I do not have serious fluid buildup in my chest.I am not pregnant and cannot become pregnant due to surgery or being postmenopausal for 2+ years.My heart, lungs, liver, kidneys, and bone marrow are functioning well.You have experienced a serious allergic reaction in the past to a certain type of antibiotic called aminoglycosides.My oxygen level is above 92% without assistance, and I haven't used GCSF or transfusions for this condition.
Research Study Groups:
This trial has the following groups:- Group 1: Fludarabine + Cyclophosphamide + Axicabtagene Ciloleucel
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given clearance to Axicabtagene Ciloleucel for public use?
"While there is limited evidence supporting the safety and efficacy of axicabtagene ciloleucel, our team at Power have assigned it a score of 1."
Answered by AI
What are the primary applications of Axicabtagene Ciloleucel?
"Axicabtagene Ciloleucel is a drug regularly prescribed to treat lung cancers. It has also shown efficacy in the management of multiple sclerosis, leukemia, myelocytic acute and retinoblastoma."
Answered by AI
How many individuals have been enrolled in this research?
"Affirmative. According to the clinicaltrials.gov website, this clinical trial is actively seeking participants and was first posted on December 4th 2020 with its last update occuring October 13th 2022. A total of 18 individuals are needed across a single recruitment site."
Answered by AI
What other investigations have been undertaken using Axicabtagene Ciloleucel?
"Currently, there are 894 investigations regarding Axicabtagene Ciloleucel being conducted with 161 of them at Phase 3. This medication is extensively tested throughout the United States, with numerous trials taking place in Philadelphia alone and a total of 28482 trial centres all together."
Answered by AI
Are there any remaining vacancies for participants in this research project?
"The clinical trial is presently recruiting participants, as seen in its listing on clinicaltrials.gov. It was advertised initially on December 4th 2020 and the entry has been recently modified on October 13th 2022."
Answered by AI
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