WOOF for the Cure – Canine Lymphoma Study

Patient Disease:
Canine B-cell Lymphoma

Study Name:
WOOF for the Cure – Lymphoma Study

Purpose of the Study: 
Presage Biosciences is sponsoring the study of a clinical diagnostic device called CIVO™ designed to enable the individual evaluation and prioritization of multiple anti-cancer agents in canine B-cell lymphoma without exposing the patient to systemic toxicity. During a brief outpatient procedure under sedation, the CIVO device is used to inject micro-doses of different anti-cancer drugs or combinations of drugs through the skin and directly into the canine patient’s lymph node. The node is then resected by a board-certified veterinary surgeon, and transferred to Presage scientists who evaluate each compound’s anti-cancer activity. By developing the clinical capabilities of this technology, Presage hopes to revolutionize personalized medicine and eliminate patient exposure to ineffective therapies. 

Primary Eligibility Criteria:
•    Diagnosis of B-cell lymphoma
•    Peripheral lymphadenopathy
•    >2.5 cm palpable and accessible node for injection through overlying skin
•    No evidence of hypercalcemia
•    Patient is clinically stable enough to delay treatment until after lymph node removal
•    No contraindications to surgery or anesthesia
•    Prior prednisone or chemotherapy is not exclusionary

Study Protocol:
•    Non-randomized study
•    A lymph node will be selected for CIVO microinjection and evaluated by ultrasound. 
•    Microdoses of several drugs or drug combinations will be administered directly into the lymph node during a brief outpatient procedure under sedation.
•    24 hours later, the injected lymph node will be removed by a board-certified veterinary surgeon and the tissue will be analyzed by Presage scientists to determine the anti-cancer activity of each injected compound. 

Study Budget:
The following services are covered by the study when performed by the participating veterinary clinic: 
•    Cytological confirmation of lymphoma, unless recently performed
•    Immunophenotyping
•    Blood and urine testing, unless recently performed
•    Thoracic radiographs, unless recently performed
•    Abdominal ultrasound, unless recently performed
•    Costs associated with the injection procedure
•    Complete cost for surgical removal of a lymph node
•    Up to $1000 towards approved chemotherapy protocols

Owner Responsibilities:
•    Follow appointment schedule required by study protocol
•    Cover all costs associated with treatment other than those funded by the study