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Immunotherapy Drug Combinations in the treatment of Canine Lymphoma

Enhancing the Efficacy of immunotherapy in Diffuse Large B Cell Lymphoma using rational combination approaches

Status: Suspended

Species: Dog

Veterinary Speciality: Oncology

Description

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 chemotherapy free treatment regimen that is equivalent or superior to that achieved with chemotherapy alone in terms of remission and survival.

Your dog’s treatment for lymphoma will involve intravenous administration of an antibody that targets the lymphoma cells.  Your dog will also simultaneously receive an oral anti-cancer agent   given at home. This drug has been tested extensively in dogs with cancer to ensure that the dose being given is safe.

The ultimate goal of this clinical trial is to put your dog’s lymphoma in a long-term remission. The hope is that by stimulating an immune response against the lymphoma, the immune system will be able to kill any cancer cells that may try to regrow.  As we are not using standard chemotherapy in this approach to treatment, it is possible that there will be fewer side effects than those seen with typical chemotherapy-based treatment regimens.

Inclusion Criteria

 

  • Dogs diagnosed with histologically or cytologically confirmed spontaneous B-cell lymphoma that has not yet been treated (treatment naïve)
  • Dogs must be at least 1 year of age and body weight of 10 kg or higher.
  • Dogs with lymphoma must have at least 2 peripheral lymph nodes that measure ≥ 2cm in diameter.
  • Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
  • Otherwise medically healthy with no underlying clinically significant cardiac, renal or hepatic disease.
  • Dogs must have an estimated life expectancy of at least 28 days.

Exclusion Criteria

  • Pregnant or lactating dogs
  • Evidence of CNS involvement
  • Dogs with uncontrolled autoimmune hemolytic anemia (AIHA) or immune mediated thrombocytopenia (ITP) are not eligible
  • 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).
  • Use of any prior treatment for lymphoma including more than 48 hours of steroids

Client Benefits

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).

Contact Info

For questions regarding the clinical trial please fill out this survey: Pet Eligibility Questionnaire

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