Ongoing Clinical Trials for Castleman’s Disease
Currently, there is one clinical trial investigating treatment options for Castleman’s disease. This trial focuses on adults with unicentric Castleman disease and is testing the medication nintedanib to evaluate its effectiveness in reducing disease activity. The trial is being conducted in France and aims to provide valuable information about a potential treatment approach for this rare condition.
Clinical trial locations
Study on Nintedanib for Adults with Unicentric Castleman Disease
This clinical trial is investigating nintedanib, a medication that blocks certain proteins involved in abnormal cell growth, as a potential treatment for unicentric Castleman disease. The condition involves overgrowth of cells in a single lymph node or group of lymph nodes, which can cause various symptoms and complications.
Who can participate:
- Adults aged 18 years or older
- Patients with confirmed hyaline-vascular unicentric Castleman disease diagnosed through a tissue biopsy
- Patients who have a disease lesion that cannot be completely removed by surgery or who have chosen not to undergo surgery
- Patients who can take medication by mouth
- Patients with health insurance coverage
- Patients who provide written informed consent after understanding the study details
Who cannot participate:
- Anyone under 18 years of age
- Patients without the specific unicentric hyalino-vascular type of the disease
- Patients unable to follow study procedures or take the medication as required
- Patients with other serious health conditions that might interfere with the study
- Pregnant or breastfeeding women
- Patients participating in another clinical trial simultaneously
- Patients who have had recent surgery or are planning surgery during the study period
- Patients with a history of allergic reactions to nintedanib or similar medications
What the trial involves:
The main goal of this trial is to evaluate whether nintedanib can effectively reduce the size and activity of the affected lymph node over six months. The medication is available as Ofev capsules in two strengths: 100 mg and 150 mg, taken orally. Researchers will measure disease activity using a method called Total Lesion Glycolysis, which assesses how much energy the affected tissue is using.
During the trial, participants will undergo regular assessments including imaging tests at 3 months and 6 months to track changes in the disease. Additional evaluations may include blood tests to measure nintedanib levels in the body and to assess genetic characteristics of the disease. The study will also monitor lung function and track any side effects that occur during treatment, with safety monitoring continuing up to 9 months.
Investigational drug:
Nintedanib is a tyrosine kinase inhibitor that works by blocking enzymes involved in the growth of blood vessels that supply abnormal tissue. In this trial, researchers aim to determine if nintedanib can help manage symptoms and slow the progression of unicentric Castleman disease by reducing the metabolic activity of disease lesions.
Summary
Currently, there is limited research activity in the field of Castleman’s disease clinical trials, with only one ongoing study identified. This single trial is taking place in France and focuses specifically on the unicentric form of the disease, which affects a localized area rather than multiple body sites. The study is investigating nintedanib, a medication that works by targeting specific enzymes involved in abnormal blood vessel growth.
The trial represents an important step in exploring treatment options for this rare condition, particularly for patients who cannot undergo complete surgical removal of the affected tissue or who choose not to have surgery. The six-month treatment period with ongoing monitoring aims to provide valuable data about both the effectiveness and safety of this therapeutic approach.
Patients interested in participating should note that the trial has specific requirements, including confirmed diagnosis through biopsy and the ability to take oral medication. As with any clinical trial, participation involves regular medical assessments and monitoring to ensure patient safety throughout the study period.
