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CAR T-cell Therapy

Brexucabtagene Autoleucel for Leukemia and Lymphoma (ZUMA-4 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Kite, A Gilead Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine clearance (as estimated by Cockcroft Gault or Schwartz) ≥ 60 mL/min, Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN), Total bilirubin ≤ 1.5 x ULN, except in individuals with Gilbert's syndrome, Left ventricular shortening fraction (LVSF) ≥ 30% or left ventricular ejection fraction (LVEF) ≥ 50%, as determined by an echocardiogram or multi-gated acquisition scan (MUGA), no evidence of pericardial effusion (except trace or physiological) as determined by an echocardiogram (ECHO) and no clinically significant arrhythmias, No clinically significant pleural effusion, Baseline oxygen saturation > 92% on room air

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

ZUMA-4 Trial Summary

This trial is testing a new treatment for kids with leukemia or non-Hodgkin lymphoma who have relapsed or are refractory to other treatments.

Who is the study for?

This trial is for children and adolescents up to 21 years old with relapsed/refractory B-precursor acute lymphoblastic leukemia or B-cell non-Hodgkin lymphoma. They must have a certain level of disease in the bone marrow, be intolerant or unresponsive to specific therapies, weigh at least 6 kg, and have good performance status and organ function. Those with CNS involvement, other cancers within 3 years (except some skin cancers), severe allergies, or recent heart issues cannot join.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of brexucabtagene autoleucel (KTE-X19) combined with fludarabine and cyclophosphamide chemotherapy in young patients who haven't responded well to previous treatments. The focus is now on those with B-cell non-Hodgkin lymphoma as recruitment for acute B-cell ALL has ended.See study design

What are the potential side effects?

Possible side effects include allergic reactions to medication components, organ inflammation due to immune response, fatigue from treatment burden, digestive disturbances from chemotherapy drugs used alongside KTE-X19 therapy.

ZUMA-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ZUMA-4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT)

Phase 2: Objective Response Rate in the NHL Cohorts

Phase 2: Overall Complete Remission Rate in the ALL Cohort

Secondary outcome measures

Allogeneic Stem Cell Transplant Rate in the ALL Cohort

CR Rate Within 3 Months Per Independent Review in ALL Cohorts

Changes Over Time in Patient Reported Outcomes (PRO) Scores in the ALL and NHL Cohorts

+8 more

ZUMA-4 Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment3 Interventions

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR+ T cells/kg or 1 x 10^6 anti-CD19 CAR+ T cells/kg

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1080

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor

44 Previous Clinical Trials

3,985 Total Patients Enrolled

Kite Study DirectorStudy DirectorKite, A Gilead Company

29 Previous Clinical Trials

3,343 Total Patients Enrolled

Media Library

Brexucabtagene Autoleucel (KTE-X19) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02625480 — Phase 1 & 2

B-Cell Non-Hodgkin Lymphoma Research Study Groups: Single Arm

B-Cell Non-Hodgkin Lymphoma Clinical Trial 2023: Brexucabtagene Autoleucel (KTE-X19) Highlights & Side Effects. Trial Name: NCT02625480 — Phase 1 & 2

Brexucabtagene Autoleucel (KTE-X19) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02625480 — Phase 1 & 2

Frequently Asked Questions

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

How extensive is the participant base of this medical research?

"This research is not currently seeking participants. It was initially posted February 1st 2016 and subsequently updated November 2nd 2022. Currently, there are 2901 trials searching for individuals with relapsed/refractory b-precursor acute lymphoblastic leukemia (ALL) and 890 studies actively recruiting patients for Brexucabtagene Autoleucel (KTE-X19)."

Answered by AI

Are any of the sites hosting this trial located in North America?

"This trial is currently being conducted at 15 medical centres, including those based in Honolulu, Los Angeles and Miami. To minimise the need for travel when taking part in this study, it may be prudent to select a site closest to you."

Answered by AI

Has Brexucabtagene Autoleucel (KTE-X19) been tested in clinical trials prior to this one?

"Brexucabtagene Autoleucel (KTE-X19) was initially investigated at City of Hope Comprehensive Cancer Center in 1997. In the current day, there have been 1275 studies completed and 890 still ongoing at various locations around the world; a majority of which are based out of Honolulu, Hawaii."

Answered by AI

Are there any vacancies left for this trial?

"Clinicaltrials.gov's information indicates that this medical study is no longer open for recruitment, as it was initially posted in February 2016 and last updated on November 2nd 2022. Despite this, there are still 3,791 other clinical trials actively searching for patients at the moment."

Answered by AI

What illnesses and conditions is Brexucabtagene Autoleucel (KTE-X19) typically prescribed to address?

"Brexucabtagene Autoleucel (KTE-X19) offers a potential course of treatment for patients suffering from multiple sclerosis, leukemia, myelocytic, acute and refractory b-cell precursor acute lymphoblastic leukemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

2016. "Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02625480.

All > Hawaii > Virginia