Clinical Trials in B-Cell Lymphoma

Study Description:

This study will proceed according to a two-center, open-label, nonrandomized, clinical trial in dogs with treatment naïve DLBCL.  Treatment of dogs will continue in absence of disease progression, unacceptable toxicity, or withdrawal from treatment. Approximately 10 dogs with spontaneous lymphoma will be enrolled in this study.  Dogs will be administered anti-CD20 intravenously (IV) once per week every 3 weeks in conjunction with oral RV1001 on a 4 days on/3 days off schedule for 4 cycles (12 weeks), or until clinical progression. At Day 96 assessment, dogs will either go off-study, or continue receiving RV1001 alone until clinical progression. Analysis of patients for tumor response will be performed by direct tumor measurement, or through the use of imaging techniques such as radiography or ultrasound. Standard bloodwork (CBC, chemistry panel) will be performed prior to each week’s treatment. Plasma samples, lymph node fine needle aspirates and tumor biopsies will be obtained for pharmacodynamic analysis and exploratory studies.  The dose of anti-CD20 will be 10 mg/kg IV once every 3 weeks based on a previously published study in healthy research dogs, and the dose of RV1001 will be 10 mg/kg once per day on a 4 days on/3 days off regimen based on previous phase 1 and 2 clinical trials in dogs with lymphoma.

Location/Study Sites:

Tufts University

Cornell University

Study Type:

Interventional

Primary Study Contact:

Cheryl London

614-915-7409

cheryl.london@tufts.edu

Inclusion Criteria:

Eligible patients (any breed of dog) must meet all of the following 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).

    • ≥1000/μL and platelet count ≥ 100,000/μL

    • Liver: Total bilirubin ≤ 1.5X the institutional upper limit of normal (ULN), ALT ≤ 3X ULN

    • Renal: Serum creatinine ≤ 1.5X ULN

    • ECOG performance score of 0-1

    • Lymphocyte count ≥ 500/µL

  • 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.

  • Informed written consent must be obtained

Exclusion Criteria:

Patients (dogs) meeting any of the following criteria will not be eligible for the study:

  • 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 hrs of steroids

© 2019 PRECINCT | PennVet | Philadelphia, PA | 215-573-2935

  • Facebook Social Icon
  • Twitter Social Icon
  • Instagram Social Icon