Study Description

This randomized, double-masked, placebo-controlled, GCP pivotal field study is evaluating the effectiveness and safety of verdinexor for the treatment of naïve or first relapse stages II, III and IV lymphoma in client owned dogs. Diagnosis of lymphoma must be confirmed by cytology or biopsy for the dog to be eligible for this study. Dogs will be randomized to receive the investigational veterinary product or a placebo treatment (tablets) to be administered with food twice weekly at least 72 hours apart for 8 weeks. After receiving treatment in-hospital on Day 0, the dog will be required to return to the study site on Days 7, 14, 28, 42, and 56 for follow up evaluation visits. Owners will be required to report and record abnormal daily observations and dosing using a phone app at home throughout the study.

Funding

This study is fully funded. Funding includes the initial study screening, the study treatment and administration, scheduled study lab work, recheck visits and exams, and management of side effects that are thought to be directly related to participation in the study. In addition, if your dog enrolls in the study and you are able to comply with all study requirements, a $1,000 credit will be applied to your account at the clinical study site to be used towards further medical care once your dog is off the study.

Eligibility

Dogs are eligible if they meet the following inclusion criteria:

• Written informed owner consent has been obtained prior to screening.
• Dog is ≥ 1 year, weighs ≥ 9 kg and has a life expectancy of at least 28 days.
• 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 ≥ 20 mm longest diameter (LD).
• Dog has histological or cytological diagnosis of B-cell or T-cell lymphoma (confirmed, or confirmation is pending, by flow cytometry or Polymerase Chain Reaction (PCR) assay, known as PCR for Antigen Receptor Rearrangements or PARR, prior to or during screening procedures), stages II, III, or IV:
  • Stage II: Regional lymphadenopathy (restricted to one side of diaphragm)
  • Stage III: Generalized lymphadenopathy (enlargement of lymph nodes)
  • Stage IV: Hepatosplenomegaly (provided there is also lymphadenopathy such that the Investigator can assess disease status through a physical exam)
• A modified Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 [0 = normal activity, 1 = restricted activity, decreased from pre-disease status].
• If on NSAIDs treatment, the dog has been treated for more than 2 weeks prior to enrollment.

Dogs are not eligible if they meet the following exclusion criteria:

• Dog has stage I lymphoma.
• Dog has clinical evidence of stage V lymphoma involving the CNS, gastrointestinal tract, or pulmonary system.
• Conditions that may interfere with the outcome of the study:
  • Clinically relevant abnormal laboratory results (e.g., lymphocyte count greater than 15,000 per μL)
  • Serious, concurrent medical condition (e.g., renal, cardiovascular, hepatic, endocrine, concurrent malignancy)
  • Significant bulky disease such that clinical deterioration is likely to occur even in the setting of stable disease.
• Dog has received prior radiation specifically 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 is participating in another study or is receiving an investigational therapy.
• Dog that is lactating, pregnant, or intended for breeding.

Study Sites

Akron, OH
Athens, GA
Bartlesville, OK
Dallas, TX
Denver, NC
Franklin, IN
Madison, WI
North Grafton, MA
Pittsburgh, PA
Quakertown, PA
Salt Lake City, UT

Additional study sites coming soon!