Accepting client-owned dogs for chemotherapy study

Clinical Study: Direct Comparison of CHOP and LOPP Chemotherapy and Genomic Analysis for Naïve T Cell Lymphoma in Client-Owned Dogs

Michigan State University Veterinary Medical Center Medical Oncology Service

Purpose of Study 

Up to 40% of canine lymphoma cases are caused by T lymphocytes, known as peripheral T cell lymphoma (PTCL). Generally, dogs with PTCL treated with CHOP chemotherapy tend to experience shorter remission durations and overall survival than dogs with diffuse large B cell lymphoma (DLBCL). When treated with CHOP chemotherapy, PTCL dogs have a median survival time of 4-9 months while DLBCL dogs have a median survival time of 11-13 months. Previous studies have questioned whether other, non-doxorubicin-based protocols may be better suited for dogs with PTCL. One protocol that has been repeatedly investigated is LOPP chemotherapy. Recent studies have demonstrated with dogs with PTCL treated with LOPP can experience survival times closer to 11-17 months. While these findings are promising, none of these investigations have had a control arm of dogs receiving CHOP chemotherapy.

The purpose of this study is to provide a direct comparison between the outcomes for dogs with PTCL treated with CHOP or LOPP chemotherapy. The findings of this study could help veterinarians understand if one protocol is truly superior to the other for dogs with PTCL.  

Inclusion Criteria (may be performed at MSU or at primary care)

• Confirmed T cell lymphoma diagnosis via cytology or histopathology + immunocytochemistry/immunohistochemistry/flow cytometry (T zone lymphoma not included)
• No chemotherapy for lymphoma within 7 days
• Pre-treatment with steroids permitted for up to 10 days
• Expected > 4 week survival (with treatment)
• No known dilated cardiomyopathy, ventricular arrhythmia, or liver failure 
• Adequate organ function indicated by standard laboratory tests

1. 1. 1. The following findings would be exclusionary: Neutrophils < 1.0 k/ul, Bilirubin > 0.5 mg/dl, Alkaline phosphatase (ALP) > 230 U/L, Alanine transferase (ALT) > 102 U/L, Aspartate aminotransferase (AST) > 62 U/L

Eligibility Diagnostics 

Prior to study entry, pet owners will be charged an initial consultation fee and be financially responsible and required to have the following diagnostics performed in their dog: 

• Diagnosis of T cell lymphoma with histopathology or cytology, if not already documented 
• Screening blood work and urinalysis, if not performed within 7 days 

Treatment 

Participation in the study will require visits every 7 to 14 days (until chemotherapy protocol completion) to the MSU-CVM. At the start of the study, dogs will be randomly assigned to receive either CHOP or LOPP chemotherapy. Both protocols will be administered as typically done in non-study settings. Study investigators, attending clinicians, and dog owners will not be blinded to treatment group throughout study duration. Following protocol completion, dogs will return to the MSU-CVM once monthly for one year as typical of non-study patients. Dogs will remain in the study until disease progression at which point additional treatment options can be discussed.

Compensation 

This is a partially funded trial:

• T cell diagnostic testing can be conducted at MSU or through clients’ primary care veterinarians. This diagnostic testing at MSU costs approximately $250. For dogs accepted to the study, the cost will be reimbursed by an account credit at the MSU Veterinary Medical Center at trial completion (either when the protocol is completed or the patient develops progressive disease).

• Initial evaluation appointments will be charged. For dogs accepted to the study, recheck exams during clinical trial appointments will be free of cost ($60 value per visit). Costs associated with blood work and treatment will remain the responsibility of the client (with the exception described below).
• Dogs will receive the first dose of doxorubicin (for those assigned to the CHOP protocol) or lomustine (for those assigned to the LOPP protocol) free of cost. First-dose administrative and blood work fees also will be free of cost.
• Clients are financially responsible for all treatments and diagnostics that are unrelated to the study.
• Genomic analysis will be free of cost ($1000 value).

Contact Information 

Please feel free to contact our Medical Oncology Team at (517) 353-5420 or cvm.oncoinfo@msu.edu to refer a patient or for any additional information. Referring veterinarian and client calls are welcome.