In short
Currently, there is 1 ongoing clinical trial for patients with recurrent Hairy Cell Leukaemia. This trial is testing a combination of three medications for patients who have previously been treated with purine analogs or are not suitable for standard chemotherapy. The study is being conducted in Italy and focuses on patients with a specific genetic mutation called BRAF-V600E.
Clinical trial locations
Study of Obinutuzumab, Vemurafenib, and Cobimetinib for Hairy Cell Leukemia in Patients Previously Treated with Purine Analogs or Unfit for Chemotherapy
This clinical trial is investigating a three-drug combination treatment for patients with recurrent Hairy Cell Leukaemia. The study is specifically designed for patients who have either received previous treatment with drugs called purine analogs or who are not healthy enough to receive standard chemotherapy.
Main focus and goal: The trial aims to evaluate how well a combination of obinutuzumab, vemurafenib, and cobimetinib works in treating Hairy Cell Leukaemia, particularly in patients who carry a specific genetic change known as the BRAF-V600E mutation. Researchers will observe how patients respond to these medications over time and monitor both the safety and effectiveness of this combination therapy. The study will track important outcomes including how deep the response is, how long patients remain free from disease, and overall survival rates.
Investigational drugs: The trial uses three medications in combination:
- Obinutuzumab – A monoclonal antibody given through an infusion into a vein. It works by helping the immune system recognize and destroy cancer cells by targeting specific proteins on their surface.
- Vemurafenib – An oral medication (tablet) that targets and blocks the BRAF-V600E mutation found in some cancer cells, helping to slow or stop their growth.
- Cobimetinib – An oral medication (tablet) that blocks a protein called MEK, which is part of a pathway that helps cancer cells grow. When used with vemurafenib, it can make the treatment more effective.
Who can participate – inclusion criteria:
- Adults aged 18 years or older
- Confirmed diagnosis of Hairy Cell Leukaemia with the BRAF-V600E mutation detected through testing
- Clinical need for treatment, such as having low levels of neutrophils (a type of white blood cell), low hemoglobin (protein in red blood cells), low platelets (blood clotting cells), an enlarged spleen causing symptoms, or significant involvement of other organs
- Previous treatment for the condition must have been completed at least 12 weeks before starting the study, unless it clearly did not work earlier
- Good enough general health to perform daily activities (ECOG performance status of 0-2)
- Recovery from all side effects of previous treatment
- For women of childbearing age, a negative pregnancy test within 14 days before starting the study
- Agreement to use effective contraception during treatment and for a specified period afterward (for both men and women who can have children)
- Ability to follow the study protocol and attend scheduled visits
- Signed informed consent after understanding all details and potential risks
Who cannot participate – exclusion criteria:
- Patients without the BRAF-V600E mutation
- Patients with allergies or medical reasons preventing them from taking the study drugs
- Pregnant or breastfeeding women
- Patients with other serious health conditions that might interfere with the study treatment
- Current participation in another clinical trial
- Previous history of another type of cancer, unless it was treated and has not returned for a certain period
- Active uncontrolled infection
- Recent heart attack or severe heart problems
- Severe liver or kidney problems
- History of certain mental health conditions that might affect participation in the study
Treatment approach: The study follows a step-wise approach where patients receive the three medications in combination. Obinutuzumab is administered as an intravenous infusion, while vemurafenib and cobimetinib are taken as oral tablets. Throughout the treatment, patients are regularly monitored with blood tests and imaging studies to assess how well the treatment is working and to identify any side effects.
Summary
Currently, there is one active clinical trial available for patients with recurrent Hairy Cell Leukaemia, taking place in Italy. This trial represents an important research effort for patients who have already received treatment with purine analogs or who are not suitable candidates for standard chemotherapy.
The trial is notable for testing a combination of three different drugs that work together through different mechanisms: obinutuzumab (a monoclonal antibody), vemurafenib (a BRAF inhibitor), and cobimetinib (a MEK inhibitor). This multi-pronged approach is specifically designed for patients with the BRAF-V600E mutation, which is a genetic change found in some cases of Hairy Cell Leukaemia.
For patients considering participation, it is important to note that this trial requires the presence of the BRAF-V600E mutation, which can be detected through genetic testing. Patients must also meet specific health criteria and be able to follow the treatment schedule and monitoring requirements. The study offers a potential treatment option for those who have exhausted other therapies or are not suitable for standard chemotherapy approaches.
