Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma
Phase-Based Progress Estimates
Effectiveness
Safety
Tennessee Oncology, PLLC, Nashville, TN
Relapsed or Refractory Large B-cell Lymphoma+2 More
Axicabtagene Ciloleucel - BiologicalEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
The primary objective of this study is to evaluate the rate and severity of cytokine release syndrome (CRS) and neurologic events following outpatient administration of axicabtagene ciloleucel in participants with relapsed or refractory (r/r) large B-cell lymphoma (LBCL).
Eligible Conditions
- Relapsed or Refractory Large B-cell Lymphoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 24 Secondary · Reporting Duration: Up to 24 months
Baseline, 6 Months
Change in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L) From Baseline to Month 6
Day 14
Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 14 days
Month 24
Duration of CRS and Neurologic Events Following Axicabtagene Ciloleucel Administration
Duration of Initial Hospitalization After Axicabtagene Ciloleucel Infusion
Percentage of Participants Experiencing Treatment- Emergent Adverse Events
Percentage of Participants Experiencing Treatment- Emergent Serious Adverse Events
Time to Onset of CRS and Neurologic Events Following Axicabtagene Ciloleucel Administration
Day 30
Rates of Hospitalization After Axicabtagene ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 30 days
Day 7
Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 7 days
Hour 72
Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 72 hours
Up to 24 months
Blood Levels of Axicabtagene Ciloleucel Chimeric Antigen Receptor (CAR) T-cells Over Time
Complete Response (CR) Rate as Assessed by Investigator Assessment
Duration of ICU Admission During First Hospitalization After Axicabtagene Ciloleucel Infusion
Duration of response (DOR) as Assessed by Investigator Assessment
Event Free Survival (EFS) as Assessed by Investigator Assessment
Objective Response Rate (ORR) as Assessed by Investigator Assessment
Overall Survival (OS)
Peak Serum Levels of Chemokines: IL-8, C-X-C Motif Chemokine Ligand-10 (CXCL-10), and Monocyte Chemotactic Protein-1 (MCP-1).
Peak Serum Levels of Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15
Peak Serum Levels of Immune Effector Molecules: Granzyme A, Granzyme B, and Perforin
Peak Serum Levels of Inflammatory and Immune Modulating Cytokines: IFN-γ, IL-1, IL-6, IL- 13, IL-17, IL-1, IL-1RA, Granulocyte-macrophage Colony Stimulating Factor (GM-CSF), Tumor Necrosis Factor-Alpha (TNF-α), and IL-12p40/p70
Peak Serum Levels of the Acute Phase Response Proteins: C-Reactive Protein (CRP), Serum Amyloid A (SAA), Soluble IL-2 Receptor Alpha (sIL-1Ra), Ferritin
Percentage and Severity of Participants with Treatment-emergent Cytokine Release Syndrome (CRS) and Neurologic Events
Progression-free Survival (PFS) as Assessed by Investigator Assessment
Proportion of Intensive Care Unit (ICU) Admitted Participants
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Axicabtagene Ciloleucel
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: Axicabtagene Ciloleucel · No Placebo Group · Phase 2
Axicabtagene CiloleucelExperimental Group · 4 Interventions: Axicabtagene Ciloleucel, Fludarabine, Dexamethasone, Cyclophosphamide · Intervention Types: Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 2
~1240
Dexamethasone
2007
Completed Phase 4
~2420
Cyclophosphamide
1995
Completed Phase 3
~4020
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Closest Location: Tennessee Oncology, PLLC · Nashville, TN
2009First Recorded Clinical Trial
1 TrialsResearching Relapsed or Refractory Large B-cell Lymphoma
153 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have DLBCL not otherwise specified.
You have chronic inflammation of the lung.
You have a primary cutaneous DLBCL, leg type.
You have relapsed or refractory disease after first-line chemotherapy.
You have measurable lesions according to the Lugano Response Criteria for Malignant Lymphoma.
A diagnosis of follicular lymphoma must be excluded before a diagnosis of DLBCL can be made.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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