T-CHOMP and T-LAB: Understanding the Clinical Studies
Aratana Therapeutics is sponsoring two nationwide clinical trials. Both studies are intended to evaluate how a conditionally licensed monoclonal antibody (AT-005) benefits dogs with intermediate to high grade T-cell lymphoma when paired with either single- or multi-agent chemotherapy protocols. AT-005, the first T-cell biological therapeutic, is a caninized monoclonal antibody engineered using the Aratana technology platform.
T-CHOMP: The dogs enrolled in the multi-agent chemotherapy trial will be randomized equally (1:1) to either receive placebo or the monoclonal antibody during the chemotherapy (CHOP) protocol. Study visits are required twice weekly for four weeks, once weekly for another 15 weeks, and monthly thereafter. The study duration is 18 months; however, if progressive disease occurs before the 18-month visit, dogs will be removed from the study at that time. The enrollment for this study is about 48 client-owned dogs.
T-LAB: An additional 60 dogs are to be enrolled in the single-agent + monoclonal antibody study. In this study during the first 5 weeks, all of the enrolled dogs will receive single-agent CCNU chemotherapy. After the first 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. 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 presented to the participating trial sites will be screened for enrollment. The pet owner will be 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, blood work, 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.
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