Not yet recruitingRare disease

Dose optimization study of ibrutinib drug combination in adult patients with haematological diseases

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

Adults with haematological diseases—disorders that affect the blood, bone marrow, or the system that helps fight infection—are being studied to find the safest and most effective amount of medicine to give. The main goal of the trial is to identify the optimal treatment intensity for these conditions.

Participants may receive one of several study medicines: an oral tablet called ibrutinib, an oral capsule named zanubrutinib, an intravenous infusion of linvoseltamab, a subcutaneous injection (under the skin) of elranatamab, a subcutaneous injection of teclistamab, or a subcutaneous injection of talquetamab. Oral medicines are taken by mouth, while the infusion is given through a vein and the injections are placed just under the skin. Each medication is given at a specific dose that is determined by the study plan.

People are randomly assigned to receive one of the medicines and are followed for a period of time with regular clinic visits, blood tests, and health questionnaires. Throughout the study, researchers track how long participants live (called overall survival) and other health outcomes such as disease progression and quality of life, while also monitoring for any side effects.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment
After enrollment, a baseline visit is scheduled to collect medical history, physical measurements, and laboratory tests required for the trial.
The information is used to compare future results with the starting condition.
Step 2
First dose administration
The assigned study medicine is given according to the trial arm.
If the oral medication ibrutinib is assigned, the dose is 420 mg taken by mouth once daily.
If the oral medication zanubrutinib is assigned, the dose is 320 mg taken by mouth once daily.
If the intravenous infusion linvoseltamab is assigned, the dose is 200 mg given as a single infusion over the time specified by the protocol.
If the subcutaneous injection elranatamab is assigned, the dose is 76 mg injected under the skin.
If the subcutaneous injection teclistamab is assigned, the dose is 1.5 mg per kilogram of body weight injected under the skin.
If the subcutaneous injection talquetamab is assigned, the dose is 0.8 mg per kilogram of body weight injected under the skin.
The exact frequency and total treatment period are defined in the study protocol and will be followed for the duration of participation.
Step 3
Regular monitoring visits
Follow‑up visits are scheduled at regular intervals defined by the protocol, often every 2 to 4 weeks.
At each visit, vital signs, blood tests, and any new symptoms are recorded.
The study staff checks for possible side effects and records any adverse events.
Step 4
Continuous medication administration
Oral medicines (ibrutinib or zanubrutinib) are taken at home each day at the same time, unless the protocol specifies a different schedule.
Intravenous or subcutaneous medicines are given at the clinic on the days assigned by the protocol.
The patient must not miss a dose without informing the study team, as missed doses may affect the trial results.
Step 5
Adverse event reporting
Any new health problem, worsening of existing symptoms, or unexpected feeling must be reported to the study staff as soon as possible.
The report includes the date, description, and severity of the event.
The study team records the information to evaluate safety.
Step 6
Interim assessments
Periodically, additional assessments such as imaging studies or quality‑of‑life questionnaires are completed according to the protocol.
These data help determine the effectiveness of the treatment.
Step 7
Treatment completion
When the predefined number of doses or treatment period ends, the patient stops receiving the study medicine.
A final assessment is performed to collect end‑of‑treatment data, including laboratory results and patient‑reported outcomes.
Step 8
Post‑treatment follow‑up
After stopping the study medicine, the patient continues to attend scheduled visits for a defined follow‑up period.
The purpose is to monitor long‑term safety and overall survival.

Who can join the trial?

5 criteria

Be at least 18 years old when you give your consent.
Any sex (male or female) can take part.
Have a diagnosed haematological disease – a disorder that mainly affects the blood, bone marrow, lymphatic system, or organs that make blood.
Be eligible for at least one of the study’s currently active domains (specific parts of the trial that match your condition).
Be able to sign a written informed consent, which means you understand the study and agree to join.

Who cannot join the trial?

2 criteria

Life expectancy less than 3 months: The doctor thinks you are unlikely to live more than three months, so you cannot join the study.
Inability to understand the study or follow instructions: Any health problem that makes it hard for you to understand what will happen, give permission to take part, or follow the study rules means you cannot participate.

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Verified sites

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

Aalborg University Hospital
Verified
Aalborg, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark
Region Sjaelland
Verified
Holbæk, Denmark

Trial locations

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Investigated drugs

Ibrutinib
is a pill taken by mouth that blocks a protein called Bruton’s tyrosine kinase (BTK). This protein helps certain blood cancer cells grow, so stopping it can slow the disease. In the trial, patients receive this medication to see how well it works at different treatment intensities.
Linvoseltamab
is given through an intravenous infusion, which means it is delivered directly into a vein over a short period. It is a type of targeted antibody therapy that attaches to specific cells involved in blood cancers. The study tests how effective it is when used at various dose levels.
Elranatamab
is administered as a subcutaneous injection, which is an injection just under the skin. It is a monoclonal antibody designed to recognize and attack cancer cells in the blood. The trial evaluates its safety and how well it works when the dose is adjusted.
Zanubrutinib
is an oral medication, taken as a pill, that also blocks the BTK protein, similar to ibrutinib. By inhibiting this pathway, it can help control the growth of certain blood cancers. In the study, different dosing strategies are compared to find the best balance of benefit and side effects.
Teclistamab
is delivered by subcutaneous injection. It is a bispecific antibody, meaning it can bind to two different targets at once—helping the immune system recognize and kill cancer cells. The trial examines how changing the amount given affects outcomes for patients.
Talquetamab
is also given as a subcutaneous injection. This bispecific antibody connects immune cells to cancer cells, encouraging the body’s own defenses to attack the disease. Researchers are testing various dose levels to determine the optimal treatment intensity.

What is already known about the treatment

IBRUTINIB
This medication is taken as an oral tablet, usually swallowed with water. It is an approved drug that is widely used for several blood cancers and is well described in medical literature. Ibrutinib works by blocking a protein called BTK, which helps cancer cells grow and survive. It belongs to the class of drugs known as BTK inhibitors.
LINVOSELTAMAB
Linvoseltamab is given by intravenous infusion, where the medicine is slowly dripped into a vein. It is currently being studied in clinical trials and is not yet broadly approved. The drug is a bispecific antibody that connects immune cells to cancer cells, helping the immune system attack the disease. It is classified as a bispecific T‑cell engager antibody.
ELRANATAMAB
Elranatamab is administered as a subcutaneous injection, placed under the skin. It has received regulatory approval for certain blood cancers and is also discussed in recent research. This antibody links immune cells to cancer cells by binding to BCMA and CD3, directing the body’s defenses to the tumor. It is a bispecific T‑cell engager antibody.
ZANUBRUTINIB
Zanubrutinib is taken as an oral tablet that patients swallow. It is an approved treatment for specific types of blood cancer and is well documented in the literature. The drug blocks the BTK protein, stopping signals that allow cancer cells to multiply. It is also a BTK inhibitor.
TECLISTAMAB
Teclistamab is given by subcutaneous injection, placed just under the skin. It has been approved for use in multiple myeloma and is described in recent medical publications. The medicine works by binding to BCMA on cancer cells and CD3 on immune cells, bringing them together to kill the tumor. It is a bispecific T‑cell engager antibody.
TALQUETAMAB
Talquetamab is administered as a subcutaneous injection. It is currently in late‑stage clinical trials and not yet widely approved. This antibody connects immune cells to cancer cells by targeting a protein called GPRC5D and CD3, helping the immune system destroy the disease. It belongs to the bispecific T‑cell engager antibody class.

Investigated diseases

Chronic lymphocytic leukemia
a type of blood cancer that starts in the bone marrow and creates many abnormal white blood cells. These cells grow slowly and can build up in the blood, lymph nodes, and spleen. Over time the number of healthy blood cells may fall, leading to fatigue or easy bruising. The disease often progresses in stages, with each stage showing more abnormal cells than the previous one.
Mantle cell lymphoma
a cancer that begins in a part of the immune system called the mantle zone of lymph nodes. It creates clusters of abnormal lymph cells that can spread to other lymph nodes, the spleen, and sometimes the bone marrow. As the disease advances, the affected areas may become larger and cause swelling. The pattern of growth can be steady or may speed up, showing more widespread involvement.
Waldenström macroglobulinemia
a disorder where the bone marrow makes too many abnormal white blood cells that produce a large protein called IgM. The excess protein can make the blood thicker, and the abnormal cells may collect in the spleen and lymph nodes. Over time the amount of IgM and the number of abnormal cells can rise, leading to larger organ size and more noticeable symptoms. The condition usually follows a slow, step‑by‑step course.
Multiple myeloma
a cancer of plasma cells, which are a type of white blood cell that normally makes antibodies. The malignant plasma cells grow in the bone marrow and can cause damage to bones and affect blood cell production. As the disease progresses, more bone areas may be involved and the amount of abnormal cells in the marrow increases. The pattern of growth can be gradual, with periods of slower change followed by faster expansion.