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Study of Vemurafenib and Rituximab for Untreated Hairy Cell Leukemia Patients

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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 Hairy Cell Leukemia (HCL). The study is exploring a new treatment approach that combines two medications, Vemurafenib and Rituximab, as a chemotherapy-free alternative to the standard treatment with Cladribine. The goal is to determine if this new combination is as effective and less harmful than the traditional treatment. The trial involves patients who have not previously received treatment for their HCL.

Participants in the study will receive either the new combination of Vemurafenib and Rituximab or the standard treatment with Cladribine. The study will monitor the effectiveness of these treatments by looking at how well the cancer responds and how long it takes for the cancer to return, if at all. The study will also assess the side effects experienced by participants to ensure the new treatment is safe.

The trial will take place over several months, with regular check-ups to monitor the health and progress of the participants. The study aims to provide a new treatment option for patients with Hairy Cell Leukemia that is less toxic and potentially more effective than current treatments. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The trial begins with the administration of vemurafenib and rituximab as a chemotherapy-free alternative to cladribine. This phase is designed to treat patients with previously untreated hairy cell leukemia (HCL).

    Vemurafenib is taken orally in the form of 240 mg film-coated tablets. The dosage and frequency will be determined by the healthcare provider based on individual patient needs.

    Rituximab is administered intravenously as a solution for infusion. The specific dosage and schedule will be provided by the healthcare team.

  2. Step 2

    Monitoring and assessment

    Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

    The primary goal is to achieve complete remission approximately six months after treatment initiation. This will be evaluated by an independent committee.

    Patients will undergo various tests, including blood tests and imaging, to monitor the response to treatment and to detect any minimal residual disease (MRD).

  3. Step 3

    Follow-up treatment

    If necessary, additional doses of rituximab may be administered based on the presence of MRD. This is known as MRD-guided rituximab treatment.

    The healthcare team will determine the need for further treatment based on the patient's response and any remaining disease activity.

  4. Step 4

    Long-term follow-up

    Patients will be followed up to monitor long-term outcomes, including survival free from disease progression and any subsequent treatments.

    Regular assessments will continue to ensure the patient's health and to manage any potential late side effects of the treatment.

Who can join the trial?

14 criteria

  • Patients must have a diagnosis of **HCL** (a type of blood cancer) that has not been treated before.
  • Patients must need treatment, which means they have at least one of the following: low white blood cells, low red blood cells, low platelets, enlarged spleen, or other organ issues related to the disease.
  • Patients must be able to swallow tablets and not have issues like nausea, vomiting, or problems absorbing medicine.
  • Patients should not have any serious infections that are not under control.
  • Patients must have good kidney function, which means their kidneys are working well.
  • Patients must have good liver function, which means their liver is working well.
  • The heart's electrical activity, measured by the **QTc interval**, must be within a safe range.
  • Patients must have an **ECOG Performance Status** of 0-2, which means they are fully active or have some symptoms but can still take care of themselves.
  • Patients must be 18 years or older.
  • Women who can have children must have a negative pregnancy test before starting the study.
  • Women who can have children and men must use effective birth control during the study and for a period after the study ends.
  • Patients must not have any conditions that would make it hard for them to follow the study rules or affect the study results.
  • Patients must agree to participate by signing a consent form.
  • Patients must have a specific genetic mutation called **BRAF-V600E** confirmed by a central lab.

Who cannot join the trial?

5 criteria

  • Patients who have already received treatment for their condition cannot participate.
  • Patients who do not have a diagnosis of **HCL** (Hairy Cell Leukemia) are excluded.
  • Patients who are not within the specified age range for the study cannot join. The age range is typically defined by the study but is not specified here.
  • Patients who are not part of the specified clinical trial group cannot participate. The specific group is not detailed here.
  • Patients who are considered part of a **vulnerable population** are excluded. This term generally refers to groups who may have limited ability to give informed consent or are at higher risk of harm, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

  • Vemurafenib

    is a medication used in this trial as part of an experimental therapy for treating hairy cell leukemia. It works by targeting and inhibiting a specific protein in cancer cells, which helps to stop their growth and spread.

  • Rituximab

    is another medication used in the trial, both in combination with vemurafenib and as a follow-up treatment. It is a type of therapy known as a monoclonal antibody, which targets specific proteins on the surface of cancer cells, helping the immune system to destroy them.

  • Cladribine

    is the standard therapy used in the trial for comparison with the experimental treatment. It is a chemotherapy drug that interferes with the growth of cancer cells, leading to their death.

What is already known about the treatment

  • Vemurafenib

    Vemurafenib is administered orally in tablet form. It is currently being studied as a treatment option for previously untreated patients with a diagnosis of Hairy Cell Leukemia (HCL). The medication works by inhibiting a specific protein called BRAF, which is involved in cell growth, thereby slowing down or stopping the growth of cancer cells. Vemurafenib is classified as a BRAF inhibitor and is being explored as a chemotherapy-free alternative in combination with Rituximab.

  • Rituximab

    Rituximab is administered through intravenous infusion. It is being evaluated in combination with Vemurafenib for the treatment of Hairy Cell Leukemia (HCL) in patients who have not received prior treatment. Rituximab targets a protein called CD20 found on the surface of certain white blood cells, leading to the destruction of these cells. It is classified as a monoclonal antibody and is part of a chemotherapy-free treatment strategy in this clinical trial.

Investigated diseases

Hairy Cell Leukemia (HCL) – Hairy Cell Leukemia is a rare type of blood cancer that affects the bone marrow and blood, leading to an overproduction of abnormal B lymphocytes, a type of white blood cell. These abnormal cells are characterized by their "hairy" appearance under a microscope. As the disease progresses, these cells accumulate in the bone marrow, spleen, and blood, interfering with the production of normal blood cells. This can result in symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to low blood counts. The disease typically progresses slowly, and many patients may not require immediate treatment. However, over time, the accumulation of these cells can lead to significant health issues that necessitate medical intervention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520119-41-00Estimated enrolment120 patientsSponsorUniversita Degli Studi Di Perugia

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