Study on Brexucabtagene Autoleucel for Adults with Relapsed/Refractory Hairy Cell Leukemia

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What is this study about?

This clinical trial is focused on studying a rare type of blood cancer called Hairy Cell Leukemia (HCL), which can be difficult to treat when it comes back or does not respond to previous treatments. The study is testing a new treatment called brexucabtagene autoleucel, also known by its code name KTE-X19. This treatment is a type of cell therapy, which involves using a patient’s own immune cells that are modified to better fight cancer cells. The main goal of the study is to see how effective this treatment is in helping patients with HCL.

Participants in the study will receive the treatment through an intravenous infusion, which means it will be given directly into the bloodstream. The study will monitor how patients respond to the treatment over time, looking at how well the cancer responds and how long the response lasts. The study will also track the overall health and survival of the participants, as well as the time it takes before any additional treatment might be needed.

In addition to the main treatment, other medications may be used to support the participants’ health during the study. These include methylprednisolone and dexamethasone, which are corticosteroids that help reduce inflammation, and fludarabine and cyclophosphamide, which are chemotherapy drugs that help prepare the body for the cell therapy. The study aims to provide valuable information on the safety and effectiveness of brexucabtagene autoleucel for people with relapsed or refractory HCL.

1 enrollment and initial assessment

Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the study criteria.

You must be 18 years or older, have a confirmed diagnosis of hairy cell leukemia (HCL), and have received at least two prior therapies.

2 pre-treatment phase

Before starting the main treatment, you will receive medications to prepare your body. This includes fludarabine and cyclophosphamide, administered through an intravenous infusion. These medications help to create a suitable environment for the main treatment.

The pre-treatment phase typically lasts for a few days, during which you will be closely monitored.

3 main treatment

The main treatment involves receiving brexucabtagene autoleucel, a specialized therapy administered through an intravenous infusion. This is designed to target and treat your specific type of leukemia.

You will be monitored closely during and after the infusion to manage any potential side effects.

4 post-treatment monitoring

After receiving the main treatment, you will enter a monitoring phase. This involves regular check-ups to assess your response to the treatment and to ensure your safety.

You may receive additional medications, such as methylprednisolone or dexamethasone, to help manage any side effects. These are typically given through intravenous infusion.

5 follow-up assessments

Throughout the study, you will have scheduled follow-up assessments to evaluate the effectiveness of the treatment. These assessments will help determine your response rate and overall health status.

The study aims to measure outcomes such as complete response, partial response, and overall survival.

Who Can Join the Study?

Must be a male or female who is 18 years of age or older.
Any side effects from previous treatments must be stable and have improved to a mild level (Grade 1 or lower).
Must have an ECOG performance status score of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have adequate blood and organ function.
If able to have children and engaging in heterosexual intercourse, must agree to use specified methods of contraception.
Must have a confirmed diagnosis of hairy cell leukemia (HCL) and need treatment based on at least one of the following:
- Low levels of neutrophils (a type of white blood cell) less than 1.0 x 10⁹/L
- Low levels of platelets (cells that help with blood clotting) less than 100 x 10⁹/L
- Low hemoglobin (a protein in red blood cells) less than 11 g/dL
- Symptomatic splenomegaly (enlarged spleen causing symptoms)
- Symptomatic lymphadenopathy (swollen lymph nodes causing symptoms)
Must have received at least two prior therapies, including a treatment called purine nucleoside analog (PNA) and moxetumomab pasudotox if eligible and available.

Who Cannot Join the Study?

Patients who have not been diagnosed with Relapsed/Refractory Hairy Cell Leukemia cannot participate. This is a specific type of blood cancer that has returned or is not responding to treatment.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial group cannot participate. This refers to specific categories or classifications of patients that the study is focusing on.
Patients who are not able to provide informed consent or are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups that may have limited ability to make informed decisions about their participation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Hospital Universitario De Salamanca	Salamanca	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Virgen del Rocío University Hospital	Sevilla	Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Sdjnxmygh Rcbzdon Uexfdmsmko Mfdmicg Cakucx	Nijmegen	The Netherlands
Urpmyqdtod Hzxxaauu Cyxzlwq	Cologne	Germany
Afejjrn Usfat Swzcptewy Lvcrvr Dk Bgoilrq	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.03.2023
France	Not recruiting	01.03.2023
Germany	Not recruiting	01.03.2023
Italy	Not recruiting	01.03.2023
Spain	Not recruiting	01.03.2023
Sweden	Not recruiting	01.03.2023
The Netherlands	Not recruiting	01.03.2023

Trial locations

Investigated drugs:

Brexucabtagene Autoleucel is a type of therapy that uses your own immune cells to fight cancer. In this treatment, some of your white blood cells, which are part of your immune system, are taken out of your body. These cells are then changed in a lab to help them recognize and attack cancer cells more effectively. After they are modified, the cells are put back into your body to help fight the cancer. This therapy is being tested to see how well it works for people with a specific type of blood cancer called Hairy Cell Leukemia (HCL).

Investigated diseases:

Hairy cell leukaemia

Relapsed/Refractory Hairy Cell Leukemia – Hairy Cell Leukemia is a rare type of blood cancer that affects B-lymphocytes, a kind of white blood cell. In this condition, the bone marrow produces abnormal B-cells that appear “hairy” under a microscope. These abnormal cells accumulate in the bone marrow, spleen, and blood, interfering with normal blood cell production. As the disease progresses, it can lead to a decrease in healthy blood cells, causing symptoms like fatigue, infections, and easy bruising. Relapsed or refractory cases occur when the disease returns after treatment or does not respond to standard therapies. The progression of the disease can vary, with some individuals experiencing slow changes over time.

Trial ID:

2022-501262-21-00

Protocol code:

KT-US-568-0138-D

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Brexucabtagene Autoleucel for Adults with Relapsed/Refractory Hairy Cell Leukemia

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