Pet Eligibility Questionnaire
If you believe that your pet may be eligible for this study, please complete our prescreening questionnaire for owners.
Standard treatment of lymphoma involves a 16-week conventional chemotherapy protocol with an 80% response rate for an average of 10 to 12 months. This study is an investigation to evaluate the safety and effectiveness of a new treatment (verdinexor) for lymphoma in dogs.
This pivotal field study (clinical trial) is a randomized, masked, placebo-controlled, pivotal effectiveness study. The study will test the investigational drug compared to a placebo (a tablet that does not contain the investigational drug). There is a 1 in 5 chance that your dog will receive the placebo tablets. Because this drug is conditionally licensed and commercially available you can elect to purchase this drug at your own cost; your pet would not be enrolled in the study, but it would ensure that your pet would not receive a placebo treatment.
For a dog to be eligible for study enrollment, all of the following inclusion criteria must be met:
If present, the following exclusion criteria will disqualify a dog from being enrolled in the study:
If you elect to enroll your dog in the study, the study sponsor will provide the investigational treatment for lymphoma to be used during the study and pay for the cost of the examinations and tests. Your dog will be evaluated weekly and if there is evidence of progression of lymphoma (meaning the lymph nodes are enlarging in size) your dog will complete the study and if on placebo you will be offered the study drug if you elect. If your pet is on the study drug (not placebo) and their lymphoma progresses, you can pursue additional chemotherapy treatments if you elect. Additional chemotherapy treatments are not covered by the study.
If your dog has any adverse events that are study-related and require treatment, the sponsor will cover the costs of reasonable treatment. If your dog is withdrawn due to other factors, your veterinarian will be compensated for the portion of the study your dog did complete.
Your participation in the study will be for 56 days during which time you will need to bring your dog to the veterinary clinic for scheduled or unscheduled follow-up visits. There will be a minimum of once-weekly visits to the clinic for up to 6 weeks. You will need to administer the study medication to your pet twice weekly and record the dose in a form that will be sent home with you. You will also record any abnormal health issues occurring in your pet in an additional form.
If you believe that your pet may be eligible for this study, please complete our prescreening questionnaire for owners.
If you believe you have a patient who is eligible for this clinical trial study or you would like additional information from the Clinical Trials Office at the Cummings Veterinary Medical Center, complete a referring physician questionnaire.
For questions regarding the clinical trial please email clinicaltrials@tufts.edu.