New Clinical Trial for Dogs with T-cell Lymphoma
Craig A Clifford DVM, MS, DACVIM (Oncology)
Kate Vickery, VMD, MS, DACVIM, CVA; Christine Mullin, VMD, Diplomate ACVIM (Oncology); Kristin Kicenuik, DVM, DACVIM (Oncology)
Lymphoma (LSA) is the most common cancer in dogs. About 30% of lymphomas are of the T cell immunophenotype, which is typically associated with a lower response rate and shorter overall survival (~6 months) with current CHOP-based protocols. Clearly, novel therapies are needed for this disease.
Recent evidence suggests that a subset of human T-cell LSA may have an abnormal internal signaling protein (called ITK) that can be targeted with drugs. The current trial will evaluate CP-596, which is a novel, potent, and selective small-molecule inhibitor of ITK. Clinical, pharmacokinetic, and pharmacodynamic evaluation of CP-596 will be performed in dogs with spontaneous non-Hodgkin’s T-cell LSA. Duration of the study will be dependent upon the duration of responses observed. Initially, 6 dogs will be enrolled at a twice daily starting dose based upon preclinical data. Dogs will be evaluated weekly for the first 4 weeks, then biweekly thereafter for toxicity and response to therapy. Dogs experiencing progressive disease at any time will be removed from the study. After at least 6 dogs have completed treatment or have received treatment for 12 or more weeks, a reassessment of dosing and additional dogs may be added thereafter.
- Age: At least 1-year-old on Day 0.
- Body weight: Dogs must weigh at least 10 kg on Day 0.
- All dogs must have a histologic or cytologic diagnosis of lymphoma confirmed and documentation of T-cell immunophenotype via immunohistochemistry, immunocytochemistry, flow cytometry, or PARR.
- Dogs must have adequate organ function as indicated by standard laboratory tests: (CBC, clinical chemistry, and urinalysis). Specifically, dogs must have:
- Absolute neutrophil count > 2,000 cells/mL
- Hematocrit > 25%
- Platelet count > 75,000/mL
- Serum creatinine < 2.5 mg/dL
- Bilirubin ≤1.25 times the upper normal limit
- Dogs must have a performance status of either 0 (normal activity) or 1 (reduced activity) on Day 0, according to the modified ECOG Performance Scheme (Veterinary and Comparative Oncology, 2004).
- Signed informed owner consent must be obtained prior to enrolling in the study.
- The owner must be capable of administering the drug to the dog orally twice daily and maintaining dosing records as required by the protocol.
- Dogs with B-cell or null-cell (neither B nor T cell) immunophenotype.
- Dogs that have received chemotherapy within 3 weeks of Day 0.
- Dogs that have received radiation therapy within 6 weeks of Day 0.
- Dogs that have received corticosteroids within 72 hours of Day 0.
- Concurrent malignancy other than lymphoma, or other serious systemic disorder incompatible with this study.
- Dogs that are on homeopathic/alternative therapies for their lymphoma. These should be discontinued on Day -1. Supplements such as glucosamine, chondroitin sulphate, vitamins, and essential fatty acids are permitted during the trial period.
- Dogs that have commenced acupuncture treatment less than 2 weeks prior to Day 0. (Dogs that have commenced acupuncture > 2 weeks prior to Day 0 can be included but they must stay on their acupuncture treatment during the study period).
Upon enrolment, the study is fully funded including funds in case of any adverse events.
For more information, please contact us:
Phone: (610) 296-2099
Email: [email protected]