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Study on Nintedanib for Adults with Unicentric Castleman Disease

Verified siteRegistered drugNo placebo
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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 the effects of the medication nintedanib, also known by its code name BIBF 1120, in treating a rare condition called Unicentric Castleman Disease. This disease involves the overgrowth of cells in a single lymph node, which can cause various symptoms and complications. The trial will use two forms of the medication: Ofev 100 mg soft capsules and Ofev 150 mg soft capsules, both taken orally.

The purpose of the study is to evaluate how effective nintedanib is in reducing the size and activity of the affected lymph node over a period of six months. Participants will be monitored to see if there is a decrease in the activity of the disease, measured by a method called Total Lesion Glycolysis (TLG), which assesses how much energy the affected tissue is using. The study will also track any side effects or adverse events that occur during the treatment period.

Throughout the study, participants will undergo regular assessments to monitor changes in the disease and any potential complications. These assessments will include imaging tests and evaluations of lung function, as well as blood tests to measure the concentration of nintedanib in the body. The study aims to provide valuable information on the potential benefits and risks of using nintedanib for treating Unicentric Castleman Disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. This includes being 18 years or older, having a confirmed diagnosis of unicentric Castleman disease, and agreeing to participate by signing a consent form.

  2. Step 2

    Medication administration

    The treatment involves taking nintedanib, which is available in two forms: Ofev 100 mg and Ofev 150 mg soft capsules. The medication is taken orally.

    The dosage and frequency of administration are determined by the study protocol and the healthcare provider overseeing the trial.

  3. Step 3

    Treatment duration

    The treatment with nintedanib is planned to last for a period of 6 months. During this time, the effectiveness of the medication in reducing the size and activity of the disease will be evaluated.

  4. Step 4

    Evaluation and monitoring

    Throughout the trial, regular assessments are conducted to monitor the response to treatment. This includes imaging tests at 3 months (M3) and 6 months (M6) to measure changes in the disease.

    The primary goal is to achieve a significant reduction in disease activity, specifically a decrease of more than 30% in Total Lesion Glycolysis (TLG).

  5. Step 5

    Safety and side effects

    The study also tracks any side effects or adverse events that may occur during the treatment period. This monitoring continues up to 9 months (M9) to ensure patient safety.

  6. Step 6

    Follow-up and additional assessments

    Additional evaluations may include changes in the size and characteristics of the disease, as well as any autoimmune-related complications.

    Blood tests may be conducted to assess the concentration of nintedanib in the body and to evaluate the genetic characteristics of the disease.

Who can join the trial?

6 criteria

  • Must be an adult aged 18 years or older.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.
  • Must have a confirmed diagnosis of **hyaline-vascular Unicentric Castleman disease** through a biopsy, which is a small sample of tissue taken for testing.
  • Must have a **UCD lesion** that cannot be completely removed by surgery or have chosen not to have surgery.
  • Must be able to take medication by mouth.
  • Must have health insurance coverage.

Who cannot join the trial?

8 criteria

  • Patients who are under 18 years old cannot participate.
  • Patients who do not have a condition called unicentric hyalino-vascular Castleman's disease cannot participate. This is a specific type of disease that affects the lymph nodes.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial at the same time cannot participate.
  • Patients who have had a recent surgery or are planning to have surgery during the study period cannot participate.
  • Patients who have a history of allergic reactions to the study medication or similar medications cannot participate.
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Investigated drugs

Nintedanib is a medication being studied for its effectiveness in treating Unicentric Castleman disease. The trial aims to see if nintedanib can reduce the activity of the disease over a six-month period. Nintedanib works by blocking certain proteins that contribute to the growth of abnormal cells, which may help in managing the symptoms and progression of the disease.

What is already known about the treatment

Nintedanib – Nintedanib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating unicentric hyalino-vascular Castleman's disease in adults. The main therapeutic indication is to reduce the metabolic activity of the disease lesions. At the molecular level, nintedanib works by inhibiting certain enzymes known as tyrosine kinases, which play a role in the growth of blood vessels that supply the tumor. It is classified as a tyrosine kinase inhibitor in pharmacology.

Investigated diseases

Unicentric Hyaline-Vascular Castleman's Disease – This is a rare disorder characterized by the overgrowth of cells in a single lymph node or a group of lymph nodes. It is a type of Castleman's disease that typically affects only one area of the body, unlike its multicentric counterpart. The disease often presents with enlarged lymph nodes, which may cause symptoms due to pressure on surrounding tissues. Patients may experience fatigue, fever, or weight loss, although some individuals remain asymptomatic. The condition is generally localized, and its progression is usually slow. The exact cause of this disease is not well understood, but it is not considered cancerous.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510253-42-00Protocol codeAPHP220273Estimated enrolment13 patientsSponsorAssistance Publique Hopitaux De Paris

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