Enhancing the efficacy of immunotherapy in Diffuse Large B-Cell Lymphoma in dogs
The purpose of this clinical trial is to evaluate the activity of new immunotherapy agents for the treatment of canine B cell lymphoma. The ultimate goal is to create a less intense treatment regimen that is equivalent or superior to that achieved with chemotherapy alone in terms of remission and survival.
- Dogs newly diagnosed with B cell lymphoma are eligible. Dogs must be at least 1 year of age.
- Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
- ANC1000/1.11 and platelet count? 80,000/µL
- Liver: Total bilirubin 5 1.5X the institutional upper limit of normal (ULN), ALT 5 3X ULN
- Renal: Serum creatinine 5 1.5X ULN
- ECOG performance score of 0-1
- Dogs must have an estimated life expectancy of at least 14 days.
- Dogs must not have received any prior therapy for the lymphoma.
- Informed written consent obtained
- Owner must be able to orally administer drug and return for scheduled visits according to designated schedule.
- Pregnant or lactating dogs
- Dogs with uncontrolled autoimmune hemolytic anemia (AIHA) or immune mediated thrombocytopenia (ITP) are not eligible.
- Dogs with evidence of significant bone marrow, gastrointestinal or hepatic involvement and are therefore categorized as stage b.
- Concurrent use of complementary or alternative medicines that in the opinion of the principal investigators would confound the interpretation of toxicities and/or antitumor activity of the study drug.
- Dogs with significant cardiovascular disease.
- Less than 2 weeks from a major surgical procedure.
- Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators).
- Dogs that have received any prior therapy.
The study will cover all diagnostics (bloodwork, etc) and treatments (antibody administration, oral drug) associated with the lymphoma while your dog is enrolled in this study as well as the management of any study-related side effects (an average of $5000 per dog). Except for the specific financial support described here, any tests or procedures unrelated to this study including treatment of conditions unrelated to the lymphoma are your responsibility.
Sample or Data Requirements
Your dog will undergo several blood tests/diagnostics prior to and during the course of treatment to monitor blood counts and collect plasma for additional genetic analyses. These blood draws amount to approximately 2 tbsp. of blood at each visit. We will also obtain a baseline needle biopsy of one of the lymph nodes and then 1-2 additional biopsies during the course of treatment. All biopsies will be performed under local anesthesia (no general anesthesia). We will also monitor your dog’s heart function periodically during the course of the study (this is termed an echocardiogram). Your dog’s treatment for lymphoma will involve intravenous administration of an antibody that targets the lymphoma cells (anti-CD20, similar to the human antibody Rituxan used to treat human B cell lymphoma). Your dog will also simultaneously receive either doxorubicin (DOX) chemotherapy alone or in combination with two oral drugs to stimulate the immune system to kill cancer cells (KPT-9274/RV1001) A total of 4 combined treatments will be given (one treatment every 3 weeks). Following completion of the chemotherapy/immune therapy treatment regimen, your dog will receive an oral drug twice per week called Laverdia (verdinexor) to help keep the lymphoma in remission. Laverdia has been conditionally approved by the FDA to treat lymphoma in dogs. We will need to evaluate your dog on the schedule provided to ensure that he/she is handling the treatments well and responding to therapy.
For questions regarding the clinical trial please email email@example.com.