Not recruitingRare disease

Study of Venetoclax and Blinatumomab for Adults with Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of blood cancer called relapsed/refractory B cell precursor acute lymphoblastic leukemia (BCP-ALL). This condition occurs when the cancer returns or does not respond to treatment. The study is testing a combination of two treatments: Venetoclax and Blinatumomab. Venetoclax, also known by its code names ABT-199 and GDC-0199, is a medication that comes in the form of film-coated tablets and is taken orally. Blinatumomab is a medication given through an intravenous infusion, which means it is administered directly into the bloodstream.

The purpose of this study is to determine how safe and tolerable the combination of Venetoclax and Blinatumomab is for patients, as well as to find the best dose to use. The study will also evaluate how well patients respond to this combination treatment. The trial is divided into two phases. In the first phase, researchers will focus on understanding the safety and appropriate dosage of the treatment. In the second phase, they will assess how effective the treatment is in helping patients with BCP-ALL.

Participants in the study will receive the combination of Venetoclax and Blinatumomab, and some may receive a placebo. The study will continue until the researchers gather enough information to understand the effects of the treatment. This trial aims to provide valuable insights into the potential benefits of combining these two medications for treating BCP-ALL, offering hope for improved outcomes in patients with this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the study criteria.
Step 2
Phase I treatment
The first phase focuses on determining the feasibility, safety, and tolerability of the treatment. The patient receives Venetoclax and Blinatumomab to establish the maximum tolerated dose.
Venetoclax is administered orally in the form of film-coated tablets. The dosage may vary, starting with 10 mg, 50 mg, or 100 mg tablets, depending on the treatment plan.
Blinatumomab is given intravenously as a solution for infusion. The frequency and duration of administration are determined by the study protocol.
Step 3
Phase II treatment
In the second phase, the focus shifts to evaluating the patient's response to the combination of Venetoclax and Blinatumomab.
The treatment continues with the same medications, and the patient's progress is closely monitored through regular assessments.
Step 4
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess the patient's health and response to the treatment. This includes blood tests and other necessary evaluations.
Follow-up visits are scheduled to ensure the patient's well-being and to gather data on the treatment's effectiveness.
Step 5
Completion of trial
Upon completion of the trial, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.
The study is estimated to conclude by July 2026, with all data collected and analyzed to determine the success of the treatment.

Who can join the trial?

9 criteria

The patient must provide a written informed consent before any screening procedures. This means they agree to participate after understanding the study details.
The patient must be 18 years or older.
The patient should have an ECOG performance status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
The patient must have specific molecular markers available. These are unique identifiers in the patient's genes that help track the disease.
The patient must have a diagnosis of Ph-negative, CD19-positive B-precursor acute lymphoblastic leukemia. This is a specific type of blood cancer.
The patient must have a positive MRD marker greater than 0.01% if they are in the first or second remission. MRD stands for minimal residual disease, which indicates the presence of cancer cells.
Women who can become pregnant must have a negative pregnancy test within 7 days before starting the study drug. They must also use effective birth control methods during the study and for 3 months after the last dose.
The patient must be able to understand and be willing to sign the written informed consent.
The patient must be willing to participate in the registry of the German Multicenter Study Group for Adult ALL (GMALL).

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than the one being studied.
Patients who have not experienced a return or resistance of their cancer after treatment.
Patients who are not within the specified age range for the study.
Patients who are pregnant or breastfeeding.
Patients who have a serious medical condition that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery.
Patients who have an active infection that requires treatment.
Patients who have a known allergy to the study drugs.
Patients who have a history of certain heart conditions.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Goethe University Frankfurt
Frankfurt, Germany
Verified
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany

Trial locations

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Investigated drugs

Venetoclax
is a medication used in this trial to help treat a type of blood cancer called B cell precursor acute lymphoblastic leukemia (BCP-ALL). It works by targeting and blocking a specific protein in cancer cells that helps them survive. By blocking this protein, Venetoclax can help kill the cancer cells and reduce the size of the cancer.
Blinatumomab
is an immunotherapy used in the trial to treat BCP-ALL. It works by helping the body's immune system find and destroy cancer cells. Blinatumomab connects certain immune cells to the cancer cells, allowing the immune system to attack and kill the cancer cells more effectively.

What is already known about the treatment

Venetoclax
Venetoclax is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory B cell precursor acute lymphoblastic leukemia. The main therapeutic indication for Venetoclax is its use in combination with other therapies to target specific types of leukemia. At the molecular level, Venetoclax works by inhibiting a protein called BCL-2, which helps cancer cells survive, thereby promoting their death. It is classified as a BCL-2 inhibitor in pharmacology.
Blinatumomab
Blinatumomab is administered through intravenous infusion. It is being evaluated in clinical trials for its role in treating relapsed or refractory B cell precursor acute lymphoblastic leukemia. The primary therapeutic use of Blinatumomab is to engage the body's immune system to target and destroy cancer cells. Its mechanism of action involves binding to both T cells and cancer cells, facilitating the immune system's ability to attack the cancer. Blinatumomab is classified as a bispecific T-cell engager (BiTE) in pharmacological terms.

Investigated diseases

Relapsed/Refractory B Cell Precursor 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 specifically involves B cell precursors, which are early forms of B cells, a type of white blood cell important for the immune response. The term "relapsed" refers to the return of the disease after treatment, while "refractory" indicates that the disease does not respond to treatment. This condition can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. The disease progresses as these abnormal cells multiply rapidly, crowding out normal cells and impairing the body's ability to function properly.