Canine Lymphoma
Oncology
Investigational
RECRUITING
Overview
Help us evaluate a treatment for Canine Lymphoma
Complete the registration form to find out if your pet qualifies to be in our clinical trial.
Lymphoma is one of the most commonly encountered cancers in the dog. The incidence of canine lymphoma has steadily increased with approximately 84 per 10,000 dogs diagnosed each year. 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.
Compensation
You may be eligible to receive a $1,000 credit applied to your account at the clinical study site, additionally funding for the study includes:
Initial Study Screening
Scheduled Study Lab Work
Recheck visits and Exams
Managment of side effects
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.
Additionally 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.
Schedule
Schedule:
Day 0: In-hospital treatment
Bi-weekly evaluation visits at study site
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.
Owner Responsibilities
Daily observation log and dosing using mobile app
Owners will be required to report and record abnormal daily observations and dosing using a phone app at home throughout the study.
Location
FRANKLIN IN, BARTLESVILLE OK, COPLEY OH, DALLAS TX, SOUTH SALT LAKE UT, QUAKERTOWN PA, MADISON WI, DENVER NC, DALLAS TX, NORTH GRAFTON MA, PITTSBURGH PA, ATHENS GA
Location
Franklin Animal Clinic
2990 Morton St,
Franklin, IN 46131
Manley Animal Hospital
3812 Adams Rd,
Bartlesville, OK 74006
MedVet Akron
1321 Centerview Cir,
Copley, OH 44321
MedVet Dallas
11333 Central Expy,
Dallas, TX 75243
MedVet Salt Lake City
331 Bearcat Dr,
South Salt Lake, UT 84115
Quakertown Veterinary Clinic
2250 Old Bethlehem Pike,
Quakertown, PA 18951
University of Wisconsin-Madison School of Veterinary Medicine
2015 Linden Dr,
Madison, WI 53706
East Lincoln Animal Hospital
7555 NC 73 Hwy,
Denver, NC 28037
VCA Animal Diagnostic Clinic
4444 Trinity Mills Rd,
Dallas, TX 75287
Cummings School of Veterinary Medicine Tufts University
200 Westboro Rd,
North Grafton, MA 01536
PVSEC North Hills
807 Camp Horne Rd,
Pittsburgh, PA 15237
University of Georgia
2200 College Station Rd,
Athens, GA 30605
Study Team
David BruyetteChief Medical Officer, DVM, DACVIM
Dr. David Bruyette received his Doctor of Veterinary Medicine degree from the University of Missouri. Subsequently, he completed an internship at Purdue University and residency in internal medicine at the University of California-Davis. He was a staff internist at the West Los Angeles Veterinary Medical Group and a member of the Department of Comparative Medicine at Stanford University. Dr. Bruyette was an Assistant Professor and Head of Internal Medicine at Kansas State University and Director of the Analytical Chemistry Laboratory at Kansas State. He was most recently, Medical Director of the VCA West Los Angeles Animal Hospital, one of the largest 24-hour emergency/specialty practices in the country. Dr. Bruyette is a diplomate of the American College of Veterinary Internal Medicine and a member of the Endocrine Society.
Apply today if...
Your 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.
Your dog is over 1 year old and weighs more than 9kgs (~20lbs)
Your dog is ≥ 1 year, weighs ≥ 9 kg and has a life expectancy of at least 28 days.
Your dog has a diagnosis of lymphoma
Your dog has a diagnosis of lymphoma by cytology (fine needle aspirate of the lymph node) and/or histopathology (biopsy)
Background
Canine lymphomas are a diverse group of cancers, and are among the most common cancers diagnosed in dogs collectively representing approximately 7-14% of all diagnoses. There are over 30 described types of canine lymphoma, and these cancers vary tremendously in their behavior. Some progress rapidly and are acutely life-threatening without treatment, while others progress very slowly and are managed as chronic, indolent diseases. Lymphomas may affect any organ in the body, but most commonly originate in lymph nodes, before spreading to other organs such as the spleen, liver, and bone marrow.
Causes
Unfortunately, the cause of lymphoma in dogs is not known. Although several possible causes such as viruses, bacteria, chemical exposure, and physical factors such as strong magnetic fields have been investigated, the cause of this cancer remains obscure. Suppression of the immune system is a known risk factor for the development of lymphoma in humans. Evidence for this includes increased rates of lymphoma in humans infected with the HIV virus or are on immune-suppressing drugs following organ transplantation surgery. However, the link between immune suppression and lymphoma in dogs is not clearly established.
Diagnosis
The best way to diagnose lymphoma is to perform a biopsy. A biopsy is a minor surgical procedure to remove a piece of lymph node or other organ affected by cancer. The most common methods for lymph node biopsy are Tru-cut needle biopsy, incisional wedge biopsy, or removal of an entire lymph node (excisional biopsy). The larger the biopsy sample, the better the chance for an accurate diagnosis of lymphoma. In addition to biopsy, several staging tests are also performed for dogs with lymphoma. The purpose of the staging tests is to determine how far the lymphoma has spread throughout your dog’s body. In general, the more places the lymphoma has spread to, the poorer the dog’s prognosis. However, dogs with very advanced lymphoma can still be treated and experience cancer remission (see more on treatment below). Staging tests also help us assess whether your dog has any other conditions that may affect treatment decisions or overall prognosis. The staging tests we typically recommend include blood tests, a urinalysis, x-rays of the chest and abdomen, an abdominal sonogram, and a bone marrow aspirate. Organs that appear abnormal on sonogram can be sampled with a small needle (fine needle aspirate) to confirm the presence of lymphoma.
Treatment
No preventative measures are currently available but it is recommended that breeds at a higher risk of developing lymphoma being screened by their veterinarian on a regular basis in an attempt to identify the disease at the earliest stage possible.
The most effective therapy for most types of canine lymphoma is chemotherapy. In some cases, surgery or radiation therapy may also be recommended. There are numerous chemotherapy treatment protocols for dogs with multicentric lymphoma. As discussed below, most dogs with lymphoma experience remission of their cancer following treatment, and side effects are usually not severe. Currently, the protocols that achieve the highest rates of remission and longest overall survival times involve combinations of drugs given over several weeks to months. The median length of survival of dogs with multicentric lymphoma treated with UW-25 chemotherapy is between 9-13 months. (The term “median” implies that 50% of dogs will survive beyond this time point and 50% of treated dogs will die before this time point.) Various other factors, such the type of lymphoma your dog has or its stage of disease, may affect your dog’s overall prognosis.
About Lymphoma
Canine lymphomas are a diverse group of cancers, and are among the most common cancers diagnosed in dogs collectively representing approximately 7-14% of all diagnoses. There are over 30 described types of canine lymphoma, and these cancers vary tremendously in their behavior. Some progress rapidly and are acutely life-threatening without treatment, while others progress very slowly and are managed as chronic, indolent diseases. Lymphomas may affect any organ in the body, but most commonly originate in lymph nodes, before spreading to other organs such as the spleen, liver, and bone marrow.
Unfortunately, the cause of lymphoma in dogs is not known. Although several possible causes such as viruses, bacteria, chemical exposure, and physical factors such as strong magnetic fields have been investigated, the cause of this cancer remains obscure. Suppression of the immune system is a known risk factor for the development of lymphoma in humans. Evidence for this includes increased rates of lymphoma in humans infected with the HIV virus or are on immune-suppressing drugs following organ transplantation surgery. However, the link between immune suppression and lymphoma in dogs is not clearly established.
The best way to diagnose lymphoma is to perform a biopsy. A biopsy is a minor surgical procedure to remove a piece of lymph node or other organ affected by cancer. The most common methods for lymph node biopsy are Tru-cut needle biopsy, incisional wedge biopsy, or removal of an entire lymph node (excisional biopsy). The larger the biopsy sample, the better the chance for an accurate diagnosis of lymphoma. In addition to biopsy, several staging tests are also performed for dogs with lymphoma. The purpose of the staging tests is to determine how far the lymphoma has spread throughout your dog’s body. In general, the more places the lymphoma has spread to, the poorer the dog’s prognosis. However, dogs with very advanced lymphoma can still be treated and experience cancer remission (see more on treatment below). Staging tests also help us assess whether your dog has any other conditions that may affect treatment decisions or overall prognosis. The staging tests we typically recommend include blood tests, a urinalysis, x-rays of the chest and abdomen, an abdominal sonogram, and a bone marrow aspirate. Organs that appear abnormal on sonogram can be sampled with a small needle (fine needle aspirate) to confirm the presence of lymphoma.
No preventative measures are currently available but it is recommended that breeds at a higher risk of developing lymphoma being screened by their veterinarian on a regular basis in an attempt to identify the disease at the earliest stage possible.
The most effective therapy for most types of canine lymphoma is chemotherapy. In some cases, surgery or radiation therapy may also be recommended. There are numerous chemotherapy treatment protocols for dogs with multicentric lymphoma. As discussed below, most dogs with lymphoma experience remission of their cancer following treatment, and side effects are usually not severe. Currently, the protocols that achieve the highest rates of remission and longest overall survival times involve combinations of drugs given over several weeks to months. The median length of survival of dogs with multicentric lymphoma treated with UW-25 chemotherapy is between 9-13 months. (The term “median” implies that 50% of dogs will survive beyond this time point and 50% of treated dogs will die before this time point.) Various other factors, such the type of lymphoma your dog has or its stage of disease, may affect your dog’s overall prognosis.
FAQs
Know before you register
What is a clinical trial?
What is informed consent?
What are my rights as a research participant?
What should I consider before agreeing to have my pet participate?
What questions should I ask before signing up for a clinical trial?
Will it cost me anything to take part in a research study?
How is my pet protected from injury in a study or a trial?
How are research subjects protected?
Do research participants get paid?
After the study is over can I continue to receive the study medication?
What is a clinical trial?
Doctors and scientists take part in many kinds of research studies. Clinical research helps researchers understand how best to treat patients or helps them learn more about a particular condition or disease. There are many different forms of clinical research. One common form is a clinical trial. In a clinical trial, researchers test new drugs, medical devices or treatments.
Clinical trials may seek to discover new drugs, new ways of giving patients approved drugs, new combinations of approved drugs, new surgical techniques, devices, or biological products. Clinical trials are also conducted to test cutting-edge and novel therapies, like studies that involve gene therapy or gene transfer.
What is informed consent?
Informed consent is a process that helps you learn about the research study. After learning about the study, you will be able to ask the researcher or his/her staff questions. You should only agree to take part after you clearly understand the study and feel comfortable. You should take time to talk over your decision with your doctors, family, and friends. If you agree to take part, you will be asked to sign an "informed consent form."
What are my rights as a research participant?
- You have the right to not take part in a research study.
- You have the right to drop out at anytime.
- You have the right to be given new information about the study.
- You have the right to ask questions at any time and have them answered as soon as possible.
- You also have the responsibility to stay informed during your participation in a study. You should ask questions about anything you do not understand or simply want to know.
What should I consider before agreeing to have my pet participate?
You may consider having your pet participate in a study because:
- They may benefit from the best possible treatment or an experimental treatment that would otherwise not be available.
- The veterinarians and technicians will closely monitor your pet’s progress throughout the trial.
- You would be helping researchers to improve the treatments for future patients.
You might consider not taking part in a study because:
- The experimental treatment may not work for your pet, or it could make your condition worse.
- The experimental treatment may cause side effects that no one anticipated.
- If the trial is randomized and includes a placebo (an inactive, dummy pill), your pet may not be given the experimental treatment.
- The amount of testing for efficacy and safety purposes may involve too many trips to the research office and take too much time.
There is no guarantee that a clinical trial will help your pet’s condition, but the results will contribute to knowledge that may make a difference in the future care of patients.
What questions should I ask before signing up for a clinical trial?
- If my pet is ill, will this research help them?
- What are the risks?
- What is involved? What will I have to do?
- Will I be charged anything or compensated for my participation?
- How can I end my participation if I change my mind?
- What will happen when the study is over? Will I be told the results?
- Is the study controversial?
- Whom do I contact to express concerns or obtain information?
Will it cost me anything to take part in a research study?
Clinical trials test new drugs, devices, or treatments. In some cases, taking part will not cost you anything. In other studies, the research team may bill you for drugs, devices, and services they provide. The study informed consent form will describe any costs to you in detail. If the information in the consent form is not clear, you should ask the research team to explain any costs before you sign the consent form.
How is my pet protected from injury in a study or a trial?
Your pet is protected first and foremost by being told honestly and without bias what the known and potential risks are for participating in the trial. This information will be submitted to you in a language you will be able to understand. There is an Institutional Review Board (IRB) requirement that every participant in a clinical trial be informed about the possible risks, benefits and available alternatives. All of the information necessary to assist you in determining whether or not your pet should participate in a clinical trial is provided in a document called the "informed consent document." This document informs you of how to let the investigator know if you think your pet is experiencing a problem with the research and what resources are available to help you. You should ask any questions you may have about a clinical trial before signing the informed consent document. Even after you have signed the informed consent document to have your pet participate in a clinical trial, you should always speak to the investigator if you have questions or problems.
How are research subjects protected?
The Institutional Review Board (IRB) protects people and animals in research studies. The IRB includes scientists, non-scientists, and community members. The IRB reviews, approves, and monitors all in which pets take part. This oversight keeps risks to research participants as low as possible. The IRB also keeps track of ongoing studies to make sure they are being done in the right way.
Do research participants get paid?
This varies by study and will be covered in your Informed Consent Document.
After the study is over can I continue to receive the study medication?
Generally, participation ends when the study ends because it might not be safe or effective to continue treatment based on what is known at the time. Sometimes patients can remain on the study drug if they are responding to the new treatment; however, this is the exception rather than the rule.