Study on the Safety and Effectiveness of Brexucabtagene Autoleucel for Children and Teens with Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying two types of blood cancers: Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma. These are conditions where the cancer has returned or has not responded to previous treatments. The treatment being tested in this study is called KTE-X19, which is a type of cell therapy. This therapy involves using a patient’s own immune cells, which are modified in a laboratory to better recognize and attack cancer cells. The modified cells are then infused back into the patient to help fight the cancer.

The purpose of the study is to evaluate the safety and effectiveness of KTE-X19 in children and adolescents with these types of blood cancers. The study is divided into two phases. In the first phase, the focus is on assessing the safety of the treatment. In the second phase, the study aims to determine how well the treatment works in achieving remission, which means the cancer is no longer detectable. Participants will receive the treatment through an intravenous infusion, which is a method of delivering medication directly into the bloodstream.

Throughout the study, participants will be closely monitored for any side effects and to see how their cancer responds to the treatment. The study will also look at how long any remission lasts and overall survival rates. This research is important for understanding how effective KTE-X19 is in treating these challenging forms of cancer in young patients.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria related to age, weight, and medical history.

The study focuses on individuals with relapsed or refractory B-precursor acute lymphoblastic leukemia or B-cell non-Hodgkin lymphoma.

2 initial assessment

A comprehensive health assessment is conducted to ensure adequate renal, hepatic, pulmonary, and cardiac function.

Performance status is evaluated using the Lansky or Karnofsky scale, depending on age.

3 treatment preparation

Preparation for treatment involves confirming the absence of significant health issues such as pleural effusion or arrhythmias.

Baseline oxygen saturation must be above 92% on room air.

4 treatment administration

The treatment involves the administration of brexucabtagene autoleucel through an intravenous infusion.

The product used is Tecartus 0.4 – 2 x 10⁸ cells dispersion for infusion.

5 monitoring and follow-up

Regular monitoring is conducted to assess the incidence of adverse events and the body’s response to the treatment.

The primary focus is on evaluating the safety and efficacy of the treatment, with specific attention to remission rates and overall survival.

6 completion and evaluation

The study aims to conclude by April 2026, with ongoing evaluations of treatment outcomes.

Secondary outcomes include the duration of remission, progression-free survival, and changes in patient-reported outcomes.

Who Can Join the Study?

Must have a type of cancer called relapsed or refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) or relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL).
For NHL, the cancer must be aggressive and confirmed by a test called a histology.
For ALL, the cancer must be relapsed or refractory, meaning it has returned or not responded to treatment.
Must have received certain previous treatments, including a medicine called anti-CD20 monoclonal antibody and a type of chemotherapy that includes anthracycline.
Must be under 18 years old and weigh at least 6 kg (about 13 pounds).
Must have a good level of daily activity, measured by a score called Lansky (for those under 16) or Karnofsky (for those 16 and older), with a score of 80 or higher.
Must have good kidney, liver, lung, and heart function. This includes:
- Kidney function: Creatinine clearance of at least 60 mL/min.
- Liver function: ALT/AST levels no more than 5 times the normal limit, and total bilirubin no more than 1.5 times the normal limit, unless you have a condition called Gilbert’s syndrome.
- Heart function: Left ventricular shortening fraction (LVSF) of at least 30% or left ventricular ejection fraction (LVEF) of at least 50%, with no significant fluid around the heart or irregular heartbeats.
- Lung function: Oxygen levels in the blood must be more than 92% when breathing room air.
For ALL, must have a certain amount of cancer cells in the bone marrow or be positive for Minimal/Measurable Residual Disease (MRD), which is a small number of cancer cells that remain after treatment.
If you have a type of ALL called Ph+ disease, you can participate if you cannot tolerate a treatment called tyrosine kinase inhibitor (TKI) therapy, or if the disease has returned or not responded after trying at least two different TKIs.
Must be 21 years old or younger and weigh at least 6 kg (about 13 pounds) at the time of agreeing to participate.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied cannot participate.
Patients who have not experienced a return or resistance to treatment of their cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or attend required visits cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received certain treatments recently that might affect the study cannot participate.
Patients who have allergies to the study medication or its ingredients cannot participate.
Patients who are participating in another clinical trial at the same time cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Pellegrin Hospital	Bordeaux	France
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy	Bydgoszcz	Poland
Fakultni Nemocnice Brno	Brno	Czechia
Robert Debre University Hospital	Paris	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Uwekelwvrs Mbpcmiz Crdnmc Hhqjyhojfvobughez	Hamburg	Germany
Ahymalejou Pqublwbk Hbjtgdhb Dx Mitwspgsb	Marseille	France
Formmkcta Porc Lg Isngycckezbyp Bezatbyox Dmq Hebzzdsy Uoawreqrvqdjv Ls Pzp	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	12.03.2019
France	Not recruiting	12.03.2019
Germany	Not recruiting	12.03.2019
Italy	Not recruiting	12.03.2019
Poland	Not recruiting	12.03.2019
Spain	Not recruiting	12.03.2019

Trial locations

Investigated drugs:

Brexucabtagene Autoleucel

KTE-X19 is a treatment being studied for its safety and effectiveness in children and teenagers who have certain types of blood cancers that have come back or have not responded to previous treatments. These cancers include B-precursor Acute Lymphoblastic Leukemia and B-Cell Non-Hodgkin Lymphoma. The study aims to see how well this treatment works in achieving remission, which means the cancer is no longer detectable, and to understand any side effects it may cause.

Investigated diseases:

Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells called lymphoblasts. In relapsed or refractory cases, the disease returns after treatment or does not respond to initial therapy. The progression involves the accumulation of these abnormal cells, which can crowd out normal blood cells, leading to symptoms like fatigue, infections, and bleeding. The disease can spread to other parts of the body, including the lymph nodes, liver, and spleen. It primarily affects children and young adults, but can occur at any age.

Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (r/r NHL) – This is a group of blood cancers that originate in the lymphatic system, specifically affecting B-lymphocytes. In relapsed or refractory cases, the lymphoma returns after treatment or does not respond to initial therapy. The disease progresses as cancerous B-cells multiply uncontrollably, forming tumors in lymph nodes and potentially spreading to other organs. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. It can affect individuals of any age, but certain types are more common in adults.

Trial ID:

2023-509440-97-00

Protocol code:

KTE-C19-104

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Brexucabtagene Autoleucel for Children and Teens with Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?