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Anti-inflammatory
Anakinra for Leukemia (PACER Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed or refractory B-acute lymphoblastic leukemia
Patients or their parents/legally authorized representatives (LARs) must have the ability to understand and the willingness to sign a written informed consent document
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post car-t infusion
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if giving a medication called anakinra before CAR T-cell therapy can reduce the severe side effects that can happen in children and young adults with B-acute lymphoblastic leukemia
Who is the study for?
This trial is for children and young adults under 25 with B-acute lymphoblastic leukemia (B-ALL) who are undergoing CAR T-cell therapy. They must have a significant presence of cancer cells in their bone marrow or detectable cancer cells in the blood recently.
What is being tested?
The study tests if giving Anakinra before symptoms start can prevent severe cytokine release syndrome after CAR T-cell therapy in patients with high levels of leukemia cells. It's a pilot study where all participants receive Anakinra when they develop a persistent fever.
What are the potential side effects?
Anakinra may cause reactions at the injection site, increased risk of infections, headaches, nausea, diarrhea, and potential allergic responses. The severity varies among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia has returned or didn't respond to treatment.
Select...
I (or my guardian) can understand and am willing to sign the consent form.
Select...
I am between 1 and 26 years old.
Select...
My cancer tests show CD19+ in bone marrow or other areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months post car-t infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post car-t infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of Severe CRS within 30 days of CAR T-cell infusion
Secondary study objectives
CRS and ICANS Severity
Cell expansion and plasma cytokine profiles
Complete Remission Rate
+5 moreSide 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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
273 Previous Clinical Trials
5,183,527 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
378 Previous Clinical Trials
413,046 Total Patients Enrolled