Who may be eligible for the Nintedanib Treatment in Unicentric Castleman Disease trial?

Inclusion Criteria: 1. Age ≥ (equal to or greater than) 18 years 2. Written informed consent 3. Biopsy-proven diagnosis of hyaline-vascular Unicentric Castleman disease 4. Unresectable or partially resectable UCD lesion or surgery refusal 5. Available oral route 6. Affiliated to National French social security system (registered or being a beneficiary of such a scheme) 7. Women of childbearing potential should be advised and agree to avoid becoming pregnant while receiving treatment and to use highly effective contraceptive methods at initiation of, during and at least 3 months after the last dose of treatment; pregnancy testing must be conducted prior to treatment and during treatment as appropriate; breast-feeding should be discontinued during treatment 8. In male patients, with WOCBP partner(s), willingness to use adequate contraceptive measures to prevent his partner from becoming pregnant during the study, prior to administration of the first dose of study treatment until 3 months after the last dose of study treatment Exclusion Criteria: 1. Synchronous Follicular Dendritic Cell sarcoma 2. Known hypersensitivity to nintedanib, soy or peanut or to any of the excipients of the experimental drug, or known hypersensitivity to the auxiliary drugs listed or to any of their excipients. 3. For women of childbearing age: negative serum or urine pregnancy test at inclusion and confirmed each month during the study, up to 3 months after the last dose. 4. Inability to obtain informed consent 5. Patients under legal protection 6. Liver transaminases (AST and/or ALT) \>3N 7. End-stage liver disease (Child B or C cirrhosis) 8. End-stage renal failure (CrCl\<30 mL/min) 9. Severe hemorrhagic or thromboembolic events in the past 6 months 10. Uncontrolled systemic illness such as chronic heart failure, unstable angina, hypertension; history of myocardial infarction or stroke or aneurysm 11. Major injuries in the 10 days prior to start of the study, or Recent surgery with inadequate wound healing, or Abdominal surgery in the past 4 weeks. 12. Severe pulmonary hypertension 13. Bleeding risk, any of the following: 1. Known genetic predisposition to bleeding. 2. Patients who require 1\. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin) 2. High dose antiplatelet therapy corresponding to a combination of two anti-platelet aggregation treatment (aspirin + an Inhibitor of P2Y12 receptor) 14. Contraindication to the experimental drug or auxiliary drugs listed 15. Patients under guardianship or curatorship and protected adults or unable to consent 16. Enrollment in another interventional study (ongoing at the time of inclusion)

ClinicalTrials.gov record NCT06643091

Nintedanib Treatment in Unicentric Castleman Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

Nintedanib Treatment in Unicentric Castleman Disease

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

Age18 years old and older

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This phase 2, single-group study gives oral nintedanib to adults with biopsy-proven hyaline-vascular unicentric Castleman disease who cannot have complete surgery or refuse it. Treatment is planned for six months (usual dose 150 mg twice daily, with a lower dose option) and includes imaging and clinical checks to track lesion activity, size, and safety. The study records metabolic changes on PET/CT at 3 and 6 months and monitors safety through about 9 months.

What it is studying. The study evaluates whether nintedanib changes lesion metabolic activity (measured by Total Lesion Glycolysis on PET/CT) and lesion size in unresectable or partially resectable hyaline-vascular unicentric Castleman disease, and it collects safety data and measures that might relate to response (including PDGFRB mutation status).

What the researchers hope to learn. To learn whether nintedanib changes the metabolic activity and size of unicentric Castleman disease lesions, to assess safety and tolerability in this patient group, to see if PDGFRB mutation status relates to response, and to evaluate effects on associated autoimmune/paraneoplastic complications.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Unicentric Castleman Disease (UCD) is a rare non-malignant localised disease involving one or more lymph nodes, associating germinal centre atrophy, mantle zone thickening and intense vascular proliferation penetrating the germinal centres. Patients usually seek medical attention because of a localised, sometimes compressive, lymph node or the development of life-threatening autoimmune complications (paraneoplastic pemphigus or PNP or myasthenia gravis or MG). The best treatment option is complete surgical excision, but it has been recently demonstrated that up to half of the patients cannot undergo surgery. In these patients, an efficient medical approach needs be defined, as no current medical treatment has demonstrated to lower morbidity and mortality. The cause of UCD is currently unknown and current data favour a scenario of stromal impairment leading to the loss of lymph node architecture rather than one of a primary hematopoietic disease. UCD lesions are often associated with synchronous follicular dendritic cell (FDC) proliferation and can sometimes evolve towards a true FDC sarcoma (FDCS), indicating a possible role for FDC, a germinal centre stromal cell component, in UCD pathogenesis. A recurrent somatic activating mutation in PDGFRB (p.N666S) has been recently described in the CD45 negative (non-hematopoietic) compartment of up to 17% UCD specimens. Moreover, activation of the VEGFR pathway is thought to play a role in the development of the disease, especially in the increased vascularity characteristic of the UCD lesion. Nintedanib is a commercially available tyrosine-kinase inhibitor targeting PDGF, VEGF and FGF receptors. The drug has obtained European Market Authorization in 2015 for the treatment of Non-Small Cell Lung Cancer and Idiopathic Pulmonary Fibrosis with a satisfactory safety profile. The hypothesis is that nintedanib could benefit patients with unresectable or partially resectable UCD.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Nintedanib

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Age ≥ (equal to or greater than) 18 years
Written informed consent
Biopsy-proven diagnosis of hyaline-vascular Unicentric Castleman disease
Unresectable or partially resectable UCD lesion or surgery refusal
Available oral route
Affiliated to National French social security system (registered or being a beneficiary of such a scheme)
Women of childbearing potential should be advised and agree to avoid becoming pregnant while receiving treatment and to use highly effective contraceptive methods at initiation of, during and at least 3 months after the last dose of treatment; pregnancy testing must be conducted prior to treatment and during treatment as appropriate; breast-feeding should be discontinued during treatment
In male patients, with WOCBP partner(s), willingness to use adequate contraceptive measures to prevent his partner from becoming pregnant during the study, prior to administration of the first dose of study treatment until 3 months after the last dose of study treatment

Exclusion criteria

Synchronous Follicular Dendritic Cell sarcoma
Known hypersensitivity to nintedanib, soy or peanut or to any of the excipients of the experimental drug, or known hypersensitivity to the auxiliary drugs listed or to any of their excipients.
For women of childbearing age: negative serum or urine pregnancy test at inclusion and confirmed each month during the study, up to 3 months after the last dose.
Inability to obtain informed consent
Patients under legal protection
Liver transaminases (AST and/or ALT) \>3N
End-stage liver disease (Child B or C cirrhosis)
End-stage renal failure (CrCl\<30 mL/min)
Severe hemorrhagic or thromboembolic events in the past 6 months
Uncontrolled systemic illness such as chronic heart failure, unstable angina, hypertension; history of myocardial infarction or stroke or aneurysm
Major injuries in the 10 days prior to start of the study, or Recent surgery with inadequate wound healing, or Abdominal surgery in the past 4 weeks.
Severe pulmonary hypertension
Bleeding risk, any of the following:
Known genetic predisposition to bleeding.
Patients who require
Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin) 2. High dose antiplatelet therapy corresponding to a combination of two anti-platelet aggregation treatment (aspirin + an Inhibitor of P2Y12 receptor) 14. Contraindication to the experimental drug or auxiliary drugs listed 15. Patients under guardianship or curatorship and protected adults or unable to consent 16. Enrollment in another interventional study (ongoing at the time of inclusion)

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take oral nintedanib (usually 150 mg twice daily for 6 months; dose may be reduced to 100 mg twice daily if needed) and attend study visits with safety monitoring for up to about 9 months. Expect PET/CT scans (baseline, month 3, month 6), blood tests including drug plasma levels (months 1, 3, 6), and regular checks for side effects. Disease assessments include lesion size and PET measures (SUV, Total Lesion Glycolysis), lung function tests if bronchiolitis obliterans is present, and scoring/antibody tests for paraneoplastic pemphigus or myasthenia gravis at specified visits. Women of childbearing potential will have pregnancy tests before and monthly during treatment and must not breast‑feed while on treatment.

How the study is structured. An open-label, single-group Phase 2 drug trial. Eligible adults with biopsy-proven hyaline-vascular unicentric Castleman disease who are not fully resectable receive oral nintedanib (typically 150 mg twice daily; 100 mg twice daily if dose-adjusted) for six months. Participants have PET/CT imaging at month 3 and month 6 to assess lesion metabolic activity, regular clinical visits and blood tests for safety (followed up to about 9 months), and additional assessments for lesion size and autoimmune/paraneoplastic complications.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on Castleman disease

Clinical trials14 trials listed for Castleman diseaseEvery trial the registry lists for Castleman disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Castleman disease researchLatest monthly update: September 2026. Includes: Unicentric tumor removal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Nov 1, 2024 (estimated)
Primary completion: May 1, 2030 (estimated)
Study completion: Sep 1, 2030 (estimated)
Target enrollment: 13 participants (estimated)
Last updated on registry: Oct 15, 2024
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Assistance Publique - Hôpitaux de Paris

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

David Boutboul, MD 📞 +33142499140 ext. +33 ✉ david.boutboul@aphp.fr
Jérôme Lambert, MD PhD 📞 +33142499742 ext. +33 ✉ jerome.lambert@u-paris.fr

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

Written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Biopsy-proven: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Women of childbearing potential: Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
CrCl: A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
Contraindication: A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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