Study on Adding Blinatumomab to Treatment for Adults with Precursor B-Acute Lymphoblastic Leukemia

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called Precursor B-acute lymphoblastic leukemia (B-ALL) in adults. The study is testing a treatment called Blinatumomab, which is a special type of protein designed to help the body’s immune system target and fight cancer cells. Blinatumomab is given to patients as a solution through a vein, a process known as an infusion.

The purpose of the study is to see how well Blinatumomab works when added to the usual treatment plan for B-ALL. This includes using it during the early phase of treatment and again during a phase called consolidation therapy, which helps to strengthen the initial treatment’s effects. The study aims to find out how many patients achieve a state where no minimal residual disease (MRD) is detected after the first phase of consolidation therapy. MRD refers to the small number of cancer cells that might remain in the body after treatment, which can be a sign of how well the treatment is working.

Participants in the study will receive Blinatumomab as part of their treatment plan, and some may receive a placebo. The study will monitor various outcomes, such as the level of MRD after different treatment phases, the response of blood cells to the treatment, and the overall survival of patients. The study will also look at the side effects of the treatment and how the immune cells in the body respond to it. The trial is expected to continue until the end of 2025.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and diagnosis of precursor B-acute lymphoblastic leukemia.

Informed consent is required, ensuring understanding of the study’s purpose and procedures.

2 prephase therapy

Initial treatment phase designed to prepare the body for the main treatment.

This phase may involve medications to stabilize the condition before starting the main therapy.

3 first consolidation phase with blinatumomab

Blinatumomab, a medication administered through an intravenous infusion, is used during this phase.

The goal is to achieve a minimal residual disease (MRD) negative response, indicating a reduction in cancer cells to very low levels.

Monitoring of MRD levels is conducted to assess the effectiveness of the treatment.

4 second consolidation phase with blinatumomab

A second course of blinatumomab is administered to further reduce cancer cells.

Continued monitoring of MRD levels to evaluate treatment progress.

5 follow-up and monitoring

Regular follow-up appointments are scheduled to monitor health status and detect any potential relapse.

Assessment of overall survival and event-free survival, which measures the time without cancer progression or recurrence.

Who Can Join the Study?

The patient must have a type of blood cancer called Precursor B-acute lymphoblastic leukemia. This includes a specific type called Philadelphia positive/BCR-ABL positive ALL and another type called CD19 positive mixed phenotype acute lymphoblastic leukemia (MPAL). It does not include mature B-cell ALL or B-lymphoblastic lymphoma.
The patient must be between the ages of 18 and 70 years old.
The patient must have a WHO performance status of 0 to 2. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, while 2 means the person is up and about more than half the day but may not be able to work.
If the patient is able to become pregnant, they must have a negative pregnancy test before joining the study.
The patient must provide written informed consent, which means they agree to participate in the study after being fully informed about it.
The patient must be capable of giving informed consent, meaning they understand what the study involves and agree to participate.

Who Cannot Join the Study?

Patients with other types of cancer besides Precursor B-acute lymphoblastic leukemia cannot participate. This is a specific type of blood cancer.
Patients who have not achieved a MRD negative response after the first consolidation phase cannot participate. MRD stands for Minimal Residual Disease, which means the amount of cancer cells that remain after treatment.
Patients outside the age range of 3 to 4 years old cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Both male and female patients are eligible, but those who do not meet other criteria cannot participate.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups like children or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Universitair Ziekenhuis Gent	Gent	Belgium
Isala Klinieken Stichting	Zwolle	The Netherlands
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Meander Medical Center	Amersfoort	The Netherlands
Gasthuiszusters Antwerpen	Antwerp	Belgium
Lxhye Uqfnksooczqx Mvtsdku Cqqgenj (uarvx	Leiden	The Netherlands
Ufgmxnepupdq Mgtlhvt Cwrscdn Guggqbcfn	Groningen	The Netherlands
Avavbrxib Uxl	Amsterdam	The Netherlands
Ebyhhsx Uemqqfygdeua Muxdgub Cwtrbrq Rppfcbodu (lxipduv Mvj	Rotterdam	The Netherlands
Ulocdcnanp Os Atxrnpi	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	04.06.2018
The Netherlands	Not recruiting	04.06.2018

Trial locations

Investigated drugs:

Blinatumomab

Blinatumomab is a medication used in this trial to treat adults with precursor B-acute lymphoblastic leukemia. It is added to the prephase and consolidation therapy to help the immune system target and destroy cancer cells. The goal is to achieve a response where minimal residual disease (MRD) is not detectable after the first consolidation phase.

Precursor B-acute lymphoblastic leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells known as lymphoblasts. It primarily occurs in children but can also be found in adults. The disease progresses rapidly, leading to symptoms such as fatigue, fever, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. As the abnormal cells multiply, they crowd out normal cells, impairing the body’s ability to fight infections and carry oxygen. The condition requires prompt medical attention to manage the rapid growth of these cancerous cells.

Trial ID:

2024-511050-44-00

Protocol code:

HOVON 146 ALL

NCT ID:

NCT03541083

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Adding Blinatumomab to Treatment for Adults with Precursor B-Acute Lymphoblastic Leukemia

What is this study about?

Who Can Join the Study?

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