Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Tennessee Oncology, PLLC, Nashville, TN
Relapsed or Refractory Large B-cell Lymphoma+2 More
Axicabtagene Ciloleucel - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

Other trials for Relapsed or Refractory Large B-cell Lymphoma

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

2 of 3
This is further along than 68% of similar trials

Other trials for Relapsed or Refractory Large B-cell Lymphoma

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
Photo of Nashville  1Photo of Nashville  2Photo of Nashville  3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.