Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643091
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Nintedanib Treatment in Unicentric Castleman Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nintedanib Treatment in Unicentric Castleman Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUCastle
Brief Summary:
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 pN666S 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None