Colorado Animal Specialty & Emergency (CASE)
Description
Lymphoma is the most common malignancy in dogs, with B-cell lymphomas accounting for ~70% of all canine lymphomas. There is an unmet need for effective treatments for canine B-cell lymphoma. The standard of care for dogs with B-cell lymphoma provides relatively short median overall survival times despite high remission rates. Side effects are common and may be dose-limiting.
B-cell lymphoma occurs as a result of neoplastic transformation and clonal expansion of B-lymphocytes. Aberrant expression of multiple components of B-cell receptor (BCR) signaling has been demonstrated in canine B-cell lymphoma. Bruton’s tyrosine kinase (BTK) plays a crucial role in oncogenic signaling downstream of the BCR that is critical for the proliferation and survival of B-cells in many B-cell malignancies. The BTK inhibitor BI 705564 has the potential to achieve marked clinical responses in dogs with B-cell malignancies and addresses major unmet needs. These include the expected improvement of quality of life with minimal side effects, increased survival time, oral administration, and affordability. These characteristics will empower general practitioners to treat canine lymphoma and increase accessibility to care for dogs with lymphoma.
This study will evaluate the efficacy and safety of BI 705564 in dogs with treatment-naïve B-cell lymphoma.
Screening Eligibility
Dogs >1 year of age and weighing between 10-50 kg
At least two lymph nodes measuring >2 cm in largest diameter
Dogs cannot have received systemic corticosteroid treatment for more than 2 weeks and/or within 5 days prior to screening
No prior chemotherapy (cytotoxic chemotherapy, verdinexor/Laverdia) or radiation therapy.
No current immunotherapy treatment (e.g. monoclonal antibodies: beimvetmab/Librela, lokivetmab/Cytopoint).
Enrollment Criteria
Stage II, III, or IV B-cell lymphoma
Benefits of Participation
Participating pet owners will receive:
Screening testing, including blood work, urinalysis, chest x-rays, abdominal ultrasound, flow cytometry, and IDEXX Cancer Dx Panel are covered. Once enrolled, the study is fully funded.
What to Expect
Participating patients will be required to complete standard pre-enrollment screening that involves a physical exam, blood work, urinalysis, lymph node testing, radiographs, and ultrasound. Dogs are seen weekly, then every 2 weeks for a study duration of 12 weeks. Owners will administer oral BI 705565 daily with a meal. We will monitor blood work and lymph node size to evaluate safety and efficacy.
Interested?
Email: [email protected]
