Title:

Exploratory field trial to investigate efficacy and safety of an investigational veterinary product (IVP) in dogs with B-cell lymphoma

Investigator:

Corey Saba, DVM, DACVIM (Oncology faculty)

If interested, please have your primary veterinarian request additional information from our Clinical Trials office at 706-296-7818 or through the University of Georgia (UGA) Oncology service by calling the small animal referral coordinator at 706-542-5362.

Study description:

Canine lymphoma is a neoplasm that is sensitive to chemotherapy. Currently, the most successful protocols involve the use of a combination of drugs (CHOP). Complete remission is attainable in a majority of cases; however, the median survival time (MST) following treatment is approximately one year. This is a multi-centered, prospective, single arm open label exploratory field trial designed to assess the safety and the ability of an IVP agent as a treatment for dogs with large cell B cell lymphoma.

The following conditions must be met:

Inclusion criteria:

• Primary clinical cases of large B-cell lymphoma
• Dogs weighing at least 10 kg and no more than 50 kg and > 12 months of age
• Dogs must be naïve to treatment
• Written consent for entry to the trial from each dog’s owner/designee

Not eligible:

• Dogs with medical illness other than large B-cell lymphoma that, in the opinion of the investigator, could compromise evaluation of study endpoints
• Dogs having received previous chemotherapy, radiation therapy, immunotherapy, and/or other treatments for lymphoma, including prednisone administration for > 14 days.
• Dogs in the care of owners/designee living at a distance from the treatment center that will interfere with compliance with the treatment and follow-up schedule.

Dogs will undergo preliminary staging tests including initial consultation, physical examination, lab work, chest x-rays and abdominal ultrasound to determine trial eligibility. The IVP will be administered by mouth at home on a daily basis. Dogs will be required to return to UGA for recheck once weekly for 4 weeks, then every 2 weeks through the end of the study. The entire study period is 84 days. All rechecks and treatments must be performed at the University of Georgia Veterinary Teaching Hospital. Thereafter, dogs will exit the study. The costs of initial screening, follow-up visits, and IVP will be provided as part of the study.

Duration of study:

The study is currently OPEN.

Potential benefits to veterinary medicine:

Lymphoma is one of the most commonly diagnosed cancers in dogs. While conventional chemotherapy induces remission in the majority of dogs with multicentric lymphoma, relapses are common. Successful demonstration of efficacy and safety of this novel treatment will provide an important drug in the veterinarian’s armamentarium and a valuable option for pet owners seeking cancer treatment for their pets.