Not recruitingRare disease

Study of Obinutuzumab, Vemurafenib, and Cobimetinib for Hairy Cell Leukemia in Patients Previously Treated with Purine Analogs or Unfit for Chemotherapy

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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 involves patients who have either been previously treated with certain drugs called purine analogs or are not suitable for chemotherapy. The trial will use a combination of three medications: Obinutuzumab, Vemurafenib, and Cobimetinib. These medications are being tested together to see how well they work in treating HCL, especially in patients with a specific genetic change known as the BRAF-V600E mutation.

The purpose of the study is to understand how effective these drugs are in fighting the leukemia. The trial is organized into different groups, where patients will receive the medications in a step-by-step manner. Obinutuzumab is given as an infusion, which means it is administered directly into the bloodstream through a vein. Vemurafenib and Cobimetinib are taken as tablets by mouth. The study will observe how patients respond to these treatments over time.

Participants in the study will be monitored for any side effects and how well the leukemia responds to the treatment. The trial aims to gather information on the safety and effectiveness of the drug combination, including how long patients remain free from the disease and their overall survival. This research is important for developing better treatment options for people with Hairy Cell Leukemia.

The research process

The trial runs in 4 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 verifying the diagnosis of hairy cell leukemia (HCL) and the presence of the BRAF-V600E mutation.
A review of previous treatments and recovery from any side effects is necessary. A performance status evaluation is also performed to ensure the patient is fit for the trial.
Step 2
Treatment phase
The treatment involves a step-wise combination of three medications: vemurafenib, cobimetinib, and obinutuzumab.
Vemurafenib is administered orally in the form of Zelboraf 240 mg film-coated tablets.
Cobimetinib is also taken orally as Cotellic 20 mg film-coated tablets.
Obinutuzumab is given intravenously as Gazyvaro 1,000 mg concentrate for solution for infusion.
The specific dosage, frequency, and duration of each medication are determined based on the patient's cohort and phase within the study.
Step 3
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and to identify any adverse events. This includes blood tests and imaging studies as needed.
The primary goal is to evaluate the depth of anti-leukemic activity of the medications. Secondary assessments include tracking the time to response, relapse-free survival, and overall survival.
Patients are required to use effective contraception during treatment and for a specified period afterward to prevent pregnancy.
Step 4
Completion and evaluation
Upon completion of the treatment phase, a final evaluation is conducted to determine the overall response to the study drugs.
The study aims to meet or exceed a pre-determined rate of response, which is assessed through a per-protocol analysis.

Who can join the trial?

10 criteria

Must be a male or female patient who is at least 18 years old.
Must have a confirmed diagnosis of **HCL** (Hairy Cell Leukemia) according to specific criteria, including the presence of the **BRAF-V600E mutation**. This mutation is a change in a specific gene that can be detected with a special test.
Must have a clinical need for treatment, which means having one or more of the following: low levels of **neutrophils** (a type of white blood cell), low **hemoglobin** (a protein in red blood cells), low **platelets** (cells that help with blood clotting), an enlarged spleen that causes symptoms, or significant involvement of other organs.
Must have completed any previous treatment for HCL at least 12 weeks before starting the study medication, unless it is clear that the treatment did not work earlier.
Must have an **ECOG performance status** of 0-2, which is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, while 2 means capable of all self-care but unable to carry out any work activities.
Must have recovered from all side effects of their most recent treatment for HCL.
Premenopausal women must have a negative pregnancy test within 14 days before starting the study. Women who cannot have children may participate if they are surgically sterile or have been postmenopausal for at least one year.
Fertile men and women must use an effective method of contraception during treatment and for a specified period after treatment ends. Effective methods include implants, injectables, or intrauterine devices. Oral contraceptives are not reliable due to possible interactions with the study drugs. Total abstinence may be acceptable if it fits the patient's lifestyle.
Must not have any psychological, familial, sociological, or geographical conditions that could interfere with following the study protocol and schedule. These conditions should be discussed with the patient before joining the trial.
Must sign an informed consent form before any study-related procedures are performed. This means agreeing to participate in the study after understanding all the details and potential risks.

Who cannot join the trial?

10 criteria

Patients who do not have the specific genetic change called BRAF-V600E mutation cannot participate. This mutation is a change in a gene that can affect how cells grow.
Patients who are not able to take the study drugs due to allergies or other medical reasons are excluded.
Patients who are pregnant or breastfeeding cannot join the study.
Patients with other serious health conditions that might interfere with the study treatment are not eligible.
Patients who are currently participating in another clinical trial are not allowed to join this study.
Patients who have had another type of cancer in the past, unless it was treated and has not come back for a certain period, are excluded.
Patients who have an active infection that is not controlled are not eligible.
Patients who have had a recent heart attack or have severe heart problems cannot participate.
Patients who have severe liver or kidney problems are excluded from the study.
Patients who have a history of certain mental health conditions that might affect their ability to participate in the study are not eligible.

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Verified sites

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

Azienda Ospedaliera Papa Giovanni XXIII
Verified
Bergamo, Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Verified
Catania, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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Investigated drugs

Obinutuzumab
is a medication used in this trial to help treat patients with hairy cell leukemia. It is a type of drug known as a monoclonal antibody, which works by targeting specific proteins on the surface of cancer cells. This helps the immune system recognize and destroy these cancer cells more effectively.
Vemurafenib
is another medication involved in the trial. It is used to target and inhibit a specific mutation known as BRAF-V600E, which is found in some cancer cells. By blocking this mutation, vemurafenib can help slow down or stop the growth of cancer cells.
Cobimetinib
is used in combination with vemurafenib in this study. It works by inhibiting a protein called MEK, which is part of a pathway that helps cancer cells grow. By blocking this pathway, cobimetinib can enhance the effects of vemurafenib, making the treatment more effective against the cancer cells.

What is already known about the treatment

Obinutuzumab
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating hairy cell leukemia (HCL), particularly in patients who have previously been treated with purine analogs or are unfit for chemotherapy. It is primarily used for its anti-leukemic properties. Obinutuzumab works by targeting and binding to a specific protein on the surface of certain white blood cells, leading to their destruction. It is classified as a monoclonal antibody.
Vemurafenib
Taken orally, vemurafenib is under investigation for its role in treating HCL in patients with the BRAF-V600E mutation. It is used to inhibit the growth of cancer cells by blocking the activity of a mutated protein that promotes cell growth. Vemurafenib is classified as a BRAF inhibitor.
Cobimetinib
Administered orally, cobimetinib is being evaluated for its potential in combination therapies for HCL. It is used to enhance the effects of other cancer treatments by inhibiting a protein involved in cell division and growth. Cobimetinib is classified as a MEK inhibitor.

Investigated diseases

Hairy Cell Leukemia – Hairy Cell Leukemia (HCL) 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 cells are characterized by their "hairy" appearance under a microscope. The disease progresses slowly, often causing symptoms such as fatigue, frequent infections, and an enlarged spleen. Over time, the accumulation of these abnormal cells can interfere with the production of normal blood cells, leading to anemia, increased risk of infections, and bleeding problems. HCL is typically diagnosed in middle-aged adults and is more common in men than women.