Study of Vemurafenib and Rituximab for Untreated Hairy Cell Leukemia Patients

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Azienda Sanitaria Locale Di Pescara	Pescara	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Amxtbdp Osnxkzpplap Uukewazpvhikm Sxwliz	Siena	Italy
Antsqsd Oxogphycgxj Pdbh Glhkrtqp Xfdii	Bergamo	Italy
Umrymkatif Dtmzn Sjtwz Ds Rjwo Lq Srynhoja	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	15.01.2023

Trial locations

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.

Investigated diseases:

Hairy cell leukaemia

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 ID:

2024-520119-41-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Vemurafenib and Rituximab for Untreated Hairy Cell Leukemia Patients

What is this study about?

Who Can Join the Study?

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