Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06067048
Status:
RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-07-12
Brief Title:
Zanubrutinib in Primary Cold Agglutinin Disease
Sponsor:
Stichting Hemato-Oncologie voor Volwassenen Nederland
Organization:
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study Overview
Official Title:
Phase II Trial of Zanubrutinib in Primary Cold Agglutinin Disease CaZa Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOVON169CAD
Brief Summary:
Cold agglutinin disease CAD is defined as a chronic autoimmune hemolytic anemia AIHA with a monospecific direct antiglobulin test DAT strongly positive for C3d and the presence of cold agglutinins CA titer 64 at 4C Patients may have a B-cell clonal lymphoproliferative disorder LPD detectable in blood or marrow but no clinical or radiological evidence of malignancy CAD can lead to AIHA peripheral ischemic symptoms cold-induced peripheral symptoms such as acrocyanosis etc or both The CAs are typically monoclonal IgM antibodies produced by the clonal B-cells usually IgM kappa with specificity for the I antigen on erythrocytes There is no curative treatment Current treatment options include rituximab monotherapy however this has only a limited and short-lasting effect Rituximab in combination with chemotherapy induces deeper and more durable responses however since CAD patients typically do not have an overt malignancy this comes with concerns about short- and long-term toxicity Novel complement inhibitors may be effective for the hemolysis but are not expected to be effective against cold induced peripheral symptoms while this is directly IgM mediated Bruton Tyrosine Kinase inhibitors BTKis are effective in many B-cell lymphoproliferative disorders including the IgM producing clone of Waldenström macroglobulinemia WM and were very effective on both AIHA and peripheral ischemic symptoms in patients with CAD based on retrospective data
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None