Your session is about to expire
← Back to Search
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
Relapsed or refractory B-precursor ALL defined as one of the following: Primary refractory disease, Any relapse within 18 months after first diagnosis, Relapsed or refractory disease after 2 or more lines of systemic therapy, Relapsed or refractory disease after allogeneic transplant provided individual is at least 100 days from stem cell transplant at the time of enrollment
Disease burden defined as at least 1 of the following: Morphological disease in the bone marrow (> 5% blasts), Minimal/Measurable Residual Disease (MRD) positive (threshold 10^-4 by flow or Polymerase chain reaction (PCR)), Individuals with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
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 belowSelect...
My B-precursor ALL has come back or didn't respond to treatment.
Select...
I have a specific type of blood cancer with certain markers or have not responded well to two types of treatment.
Select...
I am 21 or younger, weigh at least 6 kg, and can do most activities.
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
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 moreZUMA-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
~3780
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,540 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,898 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 21 or younger, weigh at least 6 kg, and can do most activities.You have any tumors or abnormalities in your brain or spine, high levels of white blood cells in your cerebrospinal fluid with lymphoblasts, or any neurological symptoms. You also have a history or current presence of a brain disorder, stroke, or autoimmune disease affecting the brain. Additionally, if you have had a stroke or seizure within the past year or require medication for seizures, you cannot participate in the study.You have been diagnosed with a specific type of leukemia or lymphoma, or have had any type of cancer (except non-melanoma skin cancer or in situ carcinoma) within the last 3 years. Additionally, you have experienced a severe allergic reaction to certain types of medication.My B-precursor ALL has come back or didn't respond to treatment.I have a specific type of blood cancer with certain markers or have not responded well to two types of treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger