Colorado Animal Specialty & Emergency (CASE)

Stratification of Outcomes for Lymphoma in Dogs

CLOSED

SUMMARY OF STUDY:

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 the 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 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.

INCLUSION CRITERIA:

• Dogs >1 year of age and weighing between 10-50 kg

• At least ONE lymph node 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)

• Stage II, III, or IV B-cell lymphoma

FINANCIAL INCENTIVES:

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:

Dogs diagnosed with multicentric nodal lymphoma and no prior treatment (including corticosteroids) may be eligible for this study. Screening includes blood work, chest x-rays, lymph node biopsy, and a fine needle aspirate. Eligible dogs will receive standard 25 week-CHOP chemotherapy under the care of an Ethos Veterinary Health Oncologist. A key part of the study involves collecting blood and tissue samples to study gene variants and biomarkers. These insights aim to improve prognosis and develop better treatment options for canine lymphoma.

• Blood samples will be taken before treatment begins, and at various points during and after chemotherapy.

• Only one lymph node biopsy (during initial screening) is required.

• Treatment and monitoring will continue until disease progression (relapse).

• After progression, dogs will be removed from the study but may continue care with their Oncologist.

INTERESTED?

Email: [email protected]