Axicabtagene Ciloleucel for Relapsed/Refractory Follicular Lymphoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
TriStar Centennial Medical Center - Cell Processing, Nashville, TN
Relapsed/Refractory Follicular 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 determine if axicabtagene ciloleucel is superior to standard of care therapy (SOCT), as measured by progression-free survival (PFS) in participants with relapsed/refractory follicular lymphoma.

Eligible Conditions

  • Relapsed/Refractory Follicular Lymphoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Relapsed/Refractory Follicular Lymphoma

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Up to 5 years

Year 5
Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)
Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20)
Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30
Change From Baseline in the Physical Functioning Domain of the NHL-LG20
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L)
Changes From Baseline in the Visual Analog Scale (VAS) Scores
Year 5
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Up to 5 years
Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification
Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification
Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification
Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification
Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification
Overall Survival (OS)
Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification
Time to Next Treatment (TTNT)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Relapsed/Refractory Follicular Lymphoma

Trial Design

2 Treatment Groups

Standard of Care Therapy
1 of 2
Axicabtagene Ciloleucel
1 of 2
Active Control
Experimental Treatment

230 Total Participants · 2 Treatment Groups

Primary Treatment: Axicabtagene Ciloleucel · No Placebo Group · Phase 3

Axicabtagene CiloleucelExperimental Group · 3 Interventions: Fludarabine, Axicabtagene Ciloleucel, Cyclophosphamide · Intervention Types: Drug, Biological, Drug
Standard of Care TherapyActiveComparator Group · 7 Interventions: Lenalidomide, Bendamustine, Vincristine, Doxorubicin, Cyclophosphamide, Rituximab, Prednisone · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 2
~1240
Cyclophosphamide
1995
Completed Phase 3
~4020

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: TriStar Centennial Medical Center - Cell Processing · Nashville, TN
Photo of Nashville 1Photo of Nashville 2Photo of Nashville 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Relapsed/Refractory Follicular Lymphoma
0 CompletedClinical Trials

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
29 Previous Clinical Trials
2,624 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
23 Previous Clinical Trials
2,474 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a clinical indication for treatment.
You have at least 1 measurable lesion per the Lugano Classification.

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.