Conditionally Licensed Monoclonal Antibody + 
CCNU Chemotherapy for Dogs with T-Cell Lymphoma

ACI is currently enrolling cases in a nationwide clinical trial to evaluate a monoclonal antibody (AT-005) that is conditionally licensed by the USDA to aid in the treatment of dogs with lymphoma. The study is designed to assess the benefit of adding AT-005 to a single-agent CCNU chemotherapy protocol for dogs with intermediate to high grade T-cell lymphoma.

 

CLINICAL STUDY DETAILS

Trial Summary

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.

 

Trial Funding

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.

 

Trial Eligibility

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

 

Trial Participation

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

(520) 888-3177
Veterinary Specialty Hospital of San Diego

10435 Sorrento Valley Rd

San Diego, CA 92121

(858) 875-7500
BluePearl Veterinary Partners – Manhattan

410 West 55th St

New York, NY 10019

(212) 767-0099
Veterinary Cancer & Surgery Specialists
10400 SE Main Street
Milwaukie, OR 97222
(503) 343-9857
Veterinary Specialty Hospital of the Carolinas
6405-100 Tryon Rd
Cary, NC 27518
(919) 233-4911
BluePearl Veterinary Partners – Southfield, MI
29080 Inkster Road
Southfield, MI 48034
(248) 354-0303
Oradell Animal Hospital
580 Winters Ave
Paramus, NJ 07652
(201) 262-0010
University of Wisconsin
School of Veterinary Medicine

2015 Linden Drive
Madison, WI 53706
608-263-9754
Blue Pearl Veterinary Partners – Tampa
3000 Busch Lake Blvd
Tampa, FL 33614
813-933-8944
Veterinary Cancer Group – Orange County
2887 Edinger Ave
Tustin, CA 92780
(949) 552-8274
UC Davis School of Veterinary Medicine
One Shields Avenue
Davis, CA 95616
(530) 752-5366
Animal Medical Center
510 East 62nd Street
New York, NY 10065
(212) 838-8100
Angell Animal Medical Center
350 South Huntington Ave
Boston, MA 02130
(617) 522-7282
Chicago Veterinary Cancer Center
3130 N Clybourn Ave
Chicago, IL 60618
(872) 829-2944

 

This participating site list will be updated often, so please check again soon.