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Anakinra for CAR-T Cell Therapy Side Effects in Lymphoma
Phase 2
Waitlist Available
Led By Jae Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients (age >/= 18) with a diagnosis of relapsed CD19+ B-cell ALL, MCL, or NHL receiving commercially approved CD19-specific CAR T cells (e.g. tisagenleuleucel, axicabtagene, brexucabtagene autoleucel, etc) are eligible for the study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days from the start of treatment
Awards & highlights
Study Summary
This trial is testing if anakinra can prevent or reverse the severe side effects of CAR-T cell therapy.
Who is the study for?
This trial is for adults over 18 with relapsed B-cell ALL, MCL, or NHL who are getting approved CD19-specific CAR T cell therapy. It's not for pregnant or breastfeeding women, those with uncontrolled infections, or anyone allergic to E. coli-derived proteins.Check my eligibility
What is being tested?
The study tests if anakinra can prevent or treat severe side effects in patients undergoing CAR-T cell therapy for certain blood cancers like lymphomas and leukemia.See study design
What are the potential side effects?
Anakinra may cause reactions at the injection site, headache, nausea, diarrhea, joint pain and swelling. There might also be a risk of infection due to its effect on the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with relapsed B-cell cancer and will receive approved CAR T cell therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days from the start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days from the start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities
Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation
Side effects data
From 2018 Phase 2 & 3 trial • 104 Patients • NCT0180913219%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1 (CART Cell Group)Experimental Treatment1 Intervention
Cohort 1 Patients will receive anakinra 100mg s.c. every 12 hours starting on day 2 post CAR T cell infusion, or after 2 documented fevers of ≥38.5° C prior to day 2, whichever time point is earlier. Anakinra will be continued for 10 days.
Cohort 2 Patients will receive anakinra 100mg s.c. daily on day 0 of T cell infusion, and continue anakinra daily for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
2016
Completed Phase 4
~2240
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,558 Total Patients Enrolled
Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
14 Previous Clinical Trials
423 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I do not have any uncontrolled fungal or bacterial infections.I am not pregnant and cannot become pregnant due to surgery or being postmenopausal for 2+ years.I am 18 or older with relapsed B-cell cancer and will receive approved CAR T cell therapy.You are allergic to proteins derived from E. coli bacteria.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 (CART Cell Group)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there still spots available to participate in this experiment?
"This clinical trial, which was initially posted on October 30th 2019 is still seeking participants. Data hosted on clinicaltrials.gov shows the study has been recently revised as of August 22nd 2022."
Answered by AI
What other research has been conducted regarding the efficacy of Anakinra?
"In 2016, Anakinra was initially studied at Royal Glamorgan Hospital. Currently, there have been 68 completed trials and 33 experiments in progress; a significant number of these are located in the city of New york."
Answered by AI
How hazardous is the use of Anakinra for individuals?
"Anakinra's safety has been partially verified in Phase 2 trials, so it was given a rating of 2. Unfortunately, there is yet to be sufficient evidence regarding its efficacy."
Answered by AI
How many participants are being administered treatment in the ongoing research?
"Affirmative. Clinicaltrials.gov records confirm that this trial, first posted on October 30th 2019 and recently updated on August 22nd 2022, is actively recruiting 62 subjects across 2 medical centres."
Answered by AI
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