Study Start Date: 06/01/2014
Study End Date: 3/31/2015

Conditionally Licensed Monoclonal Antibody + Multi-agent Chemotherapy for Dogs with T-Cell Lymphoma
An estimated 60 client-owned dogs will be enrolled 
in this study. During the first 5 weeks of the study, all enrolled dogs will receive single-agent CCNU chemotherapy. After two cycles of CCNU treatment, dogs that achieve a partial or complete response will be randomized equally (1:1) to receive AT-005 or placebo twice a week for the next 4 weeks. The veterinary oncologist performing the dogs' evaluations will be blinded to each dog's group assignment. Patients will continue to receive the monoclonal antibody or placebo every other week for another 8 weeks, after which they will be rechecked monthly. The study duration is 12 months; however, if progressive disease occurs before the 12-month visit, dogs will be removed from the study at that time.

Study Design:
Prospective, randomized, double-blinded positive-control study.

Sample Size:
60 dogs.

Inclusion Criteria:

• Client-owned dog > 1 year of age.
• Body weight at least 10 kg.
• Biopsy and flow cytometry confirmation of naïve, intermediate or high grade T-cell lymphoma, Stage II or higher.
• At least one, peripherally located lymph node measuring ≥ 2 cm longest diameter.
• Performance Score of 0, 1 or 2 [0 = normal activity; 1 = restricted activity: decreased activity from pre disease status; 2 = compromised, ambulatory only for vital activities, consistently defecates and urinates in acceptable areas].

Exclusion Criteria:

• Glucocorticoid therapy for more than 7 days prior to enrollment.
• Prior chemotherapy, immunotherapy, or molecular targeted therapy.
• Any uncontrolled medical condition (including other concurrent malignancy) that may be disruptive to the intent and objectives of the study.
• Dog is pregnant or likely to become pregnant.
• Dog is participating in another study.
• Dog is unlikely to be available for the entire study duration.

Study Controls:
All dogs will receive 2 cycles of CCNU - either alone or in combination with the monoclonal antibody.

Study Endpoints:
The study duration is 12 months; however, if progressive disease occurs before the 12-month visit, dogs will be removed from the study at that time.

Costs/Reimbursements
The pet owner will be financially responsible for the initial consultation, blood/urine analysis, and thoracic radiographs. A lymph node biopsy and flow cytometry analysis will be performed at no cost to the owner. Once the dog is confirmed eligible (non-indolent, T-cell lymphoma), all procedures and treatments required by the study including chemotherapy, antibody therapy, exam, bloodwork, and other required diagnostics will be fully funded. Previous studies with this antibody have shown that side effects tend to be minimal, but the study will pay up to $1,200 for medical management of side effects that may occur, either as a result of chemotherapy or monoclonal antibody treatment.

Study Website: http://www.animalci.com/trials/t-lab
Participating Oncology centers can be found at the bottom of the page in the link above.