Study identifier:ACE-WM-001
ClinicalTrials.gov identifier:NCT02180724
EudraCT identifier:2014-003212-36
CTIS identifier:2023-509356-34-00
An Open-label, Phase 2 Study of ACP-196 in Subjects with Waldenström Macroglobulinemia
Waldenström Macroglobulinemia (WM)
Phase 2
No
Acalabrutinib (ACP-196)
All
107
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Mar 2025 by AcertaPharma
AcertaPharma
-
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.
Clinical studies have shown that targeting the B-cell receptor (BCR) signaling pathway by inhibiting Bruton tyrosine kinase (BTK) produces significant clinical benefit in patients with non-Hodgkin lymphoma, including Waldenström macroglobulinemia (WM). Ibrutinib (IMBRUVICA®), an oral, small-molecule BTK inhibitor has been approved for the treatment for chronic lymphocytic leukemia (CLL), mantle cell lymphoma, and WM. Acerta Pharma BV (AcertaPharma) has developed a novel BTK inhibitor, acalabrutinib, that achieves significant oral bioavailability and potency in preclinical models. The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.
Location
Location
Salamanca, Spain, 37007
Location
Santa Barbara, CA, United States, 93105
Location
Washington DC, DC, United States, 20007
Location
Bournemouth, United Kingdom, BH7 7DW
Location
Milan, Italy, 20162
Location
London, United Kingdom, SW3 6JJ
Location
Clermond Ferrand, France, 63003
Location
Reims Cedex, France, 51092
Arms | Assigned Interventions |
---|---|
Experimental: Previously Treated Subjects previously treated with Waldenström Macroglobulinemia N=92 | - |
Experimental: Treatment Naïve Subjects with treatment-naïve Waldenström Macroglobulinemia. N=14 | - |
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