Locations:
Study Details
BluePearl Specialty and Emergency Pet Hospital is participating in a fully funded, placebo-controlled, randomized study to confirm the efficacy and safety of verdinexor for the treatment of lymphoma in dogs. Dogs will randomly be assigned either a placebo or study drug, with a 1 in 5 chance of receiving the study drug. Owners will be required to bring their dog to the hospital for a total of eight visits over 56 days.
Inclusion Criteria
- Dog is 1 year old or older and weighs 9 kg (19.8 pounds) or more.
- Dog has naïve or first relapse lymphoma:
- Naïve: dog who has not received any treatment for lymphoma.
- First relapse: Dog has failed a single round of any chemotherapy completed at least 14 days prior to study entry and has recovered from any acute toxicity from prior chemotherapy, or is on prednisone and has exhibited progressive disease. Evidence of disease (progression) at the time of screening is based on direct measurement of at least one peripheral lymph node less than 20 mm longest diameter (LD).
- Dog has histological or cytological diagnosis of stages II, III, or IV B-cell or T-cell lymphoma (confirmed by flow cytometry prior to or during screening procedures).
- Dog has a life expectancy of at least 28 days.
- If on NSAIDs treatment, the dog has been treated for at least two weeks prior to enrollment.
Exclusion Criteria
- Dog has stage I lymphoma.
- Dog has clinical evidence of stage V lymphoma involving the CNS, gastrointestinal tract or pulmonary system.
- Dogs has a lymphocyte count greater than 15,000 per μL.
- Dog has received prior radiation specifically for the treatment of lymphoma.
- Dog has a clinically relevant abnormal laboratory result that in the opinion of the Investigator may interfere with the outcome of the study.
- Dog has a serious, concurrent medical condition (e.g., renal, cardiovascular, hepatic, endocrine, concurrent malignancy) that may preclude a successful lymphoma treatment outcome.
- Dog has significant bulky disease such that clinical deterioration is likely to occur even in the setting of stable disease.
- Dog is participating in another study or is receiving an investigational therapy.
- Dog has received any immunotherapy for the treatment of lymphoma.
- Dog is receiving complementary or alternative medicines that the investigator believes could interfere with the primary endpoint of the study.
- Dog that is lactating, pregnant or intended for breeding.
Duration of study
Enrollment period consists of 56 days.
Covered Costs
The study sponsor will cover all costs for procedures and treatments required by the study.
Pennsylvania – Pittsburgh Participation Contact Rebecca Newman at 412.366.3400.
