BridgeMD
NUCastle - Nintedanib treatment in Unicentric Castleman disease
EU CTIS ID: 2023-510253-42-00
What this study is testing
Evaluate the efficacy of nintedanib in decreasing Total Lesion Glycolysis (TLG) of the UCD lesion over a 6-month treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age equal to or greater than18 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)
You likely can't join if
- Synchronous Follicular Dendritic Cell sarcoma
- Uncontrolled systemic illness such as, chronic heart failure, unstable angina, hypertension, history or myocardial infarction in the 12 months prior to the start of the treatment
- Major injuries in the 10 days prior to start of the study / Recent surgery with wound healing in progress (<14 days)
- Bleeding risk, any of the following : a. Known genetic predisposition to bleeding. b. 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).
- Contraindication to the experimental drug or auxiliary drugs listed in section 7.3
- Enrolment in another interventional study(ongoing at the time of inclusion)
See the full eligibility criteria
- Age equal to or greater than18 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)
- Synchronous Follicular Dendritic Cell sarcoma
- Uncontrolled systemic illness such as, chronic heart failure, unstable angina, hypertension, history or myocardial infarction in the 12 months prior to the start of the treatment
- Major injuries in the 10 days prior to start of the study / Recent surgery with wound healing in progress (<14 days)
- Bleeding risk, any of the following : a. Known genetic predisposition to bleeding. b. 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).
- Contraindication to the experimental drug or auxiliary drugs listed in section 7.3
- Enrolment in another interventional study(ongoing at the time of inclusion)
- Known hypersensitivity to nintedanib, soy or peanut
- For women of childbearing age: positive serum or urine pregnancy test at inclusion and during the study period, up to 3 months after the last dose (plasmatic at inclusion)
- Inability to obtain informed consent
- Patients under guardianship or curatorship and protected adults
- Liver transaminases (AST and/or ALT) >5N
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.