CAR T-cell Therapy

axicabtagene ciloleucel for Follicular Lymphoma

Banner MD Anderson Cancer Center, Gilbert, AZ
Targeting 3 different conditionsaxicabtagene ciloleucel +2 morePhase 2Waitlist AvailableResearch Sponsored by Kite, A Gilead Company

Study Summary

This trial will enroll 160 adults with relapsed or refractory non-Hodgkin's lymphoma. Subjects will receive axicabtagene ciloleucel, an experimental product made from the subject's own genetically-modified white blood cells. The goal is to determine if the product is safe and effective.

Eligible Conditions
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Slow-Growing Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate per central read
Secondary outcome measures
Best Objective Response per Central Read or Investigator Read
CR Rate per central read
Complete response rate among those participants with 3 or more lines of prior therapy
+11 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
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: axicabtagene ciloleucelExperimental Treatment3 Interventions
Participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single infusion of CAR transduced autologous T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Find a site

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
35 Previous Clinical Trials
3,178 Total Patients Enrolled
Kite Study DirectorStudy Director
Kite, A Gilead Company
26 Previous Clinical Trials
2,879 Total Patients Enrolled

Media Library

Axicabtagene Ciloleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03105336 — Phase 2
Follicular Lymphoma Research Study Groups: axicabtagene ciloleucel
Follicular Lymphoma Clinical Trial 2023: Axicabtagene Ciloleucel Highlights & Side Effects. Trial Name: NCT03105336 — Phase 2
Axicabtagene Ciloleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03105336 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues is this experiment currently taking place in?

"Currently, 17 medical facilities are hosting this clinical trial. In addition to Seattle, Gilbert and Miami, there are 14 additional sites. To best accommodate your needs, it is important that you choose the closest clinic when deciding whether or not to join the study."

Answered by AI

Are there any openings remaining for participants in this trial?

"Clinicaltrials.gov indicates that, as of this moment, the trial is not currently accepting applications. This study was initially posted on June 20th 2017 and most recently updated November 22nd 2022; however, 2644 other medical studies are still accepting participants at present."

Answered by AI

Could you elucidate what other tests have been undertaken with axicabtagene ciloleucel?

"Currently, 894 active clinical trials are being conducted in order to further research axicabtagene ciloleucel. Of those studies, 161 have reached Phase 3 status. Furthermore, 28479 locations across the globe are researching this treatment with the majority of them located in Philadelphia, Pennsylvania."

Answered by AI

What precautions should be taken when using axicabtagene ciloleucel?

"As axicabtagene ciloleucel is only in Phase 2, the limited data available suggests it has a relatively high safety profile. Thus, our team at Power rated it as a level 2 on their scale of 1 to 3."

Answered by AI

In what clinical contexts is axicabtagene ciloleucel commonly employed?

"Axicabtagene ciloleucel can be employed therapeutically to treat a variety of diseases, such as lung cancer, multiple sclerosis and acute myelocytic leukemia."

Answered by AI

How many individuals are currently enrolled in this experiment?

"At the present time, this investigation is not actively recruiting participants. It was initially posted on June 20th 2017 and last updated November 22nd 2022. Other studies in related fields include 1,750 trials for those with lymphoma and 894 involving axicabtagene ciloleucel that are currently looking for patients to take part."

Answered by AI
Recent research and studies
~26 spots leftby Jan 2025