CLINICAL STUDY DETAILS
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.
Dogs presenting to the participating trial site will be screened for enrollment. The pet owner will be financially responsible for the initial consultation, bloodwork/urinanalysis, 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 monoclonal 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 AT-005 treatment.
To qualify for enrollment, dogs must meet the following 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]
Dogs cannot be enrolled if any of the following conditions are met:
- Glucocorticoid therapy for more than 7 days prior to enrollment
- Prior chemotherapy, immunotherapy, or molecular- targeted therapy
- ALT ≥ 2x upper limit of normal at enrollment
- Any serious 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 may not be available for the entire study duration
The following veterinary oncology centers are offering this clinical trial:
Southern Arizona Veterinary Specialty and Emergency Center
141 E. Fort Lowell Rd
Tucson, AZ 85705
Veterinary Specialty Hospital of San Diego
10435 Sorrento Valley Rd
San Diego, CA 92121
BluePearl Veterinary Partners (Manhattan)
410 West 55th St
New York, NY 10019
Veterinary Cancer & Surgery Specialists
10400 SE Main Street
Milwaukie, OR 97222
Veterinary Specialty Hospital of the Carolinas
6405-100 Tryon Rd.
Cary, NC 27518
|BluePearl Veterinary Partners (MI)
29080 Inkster Road
Southfield, MI 48034
|Oradell Animal Hospital
580 Winters Ave.
Paramus, NJ 07652
This participating site list will be updated often, so please check again soon.