Policy Lab

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

SGN35-028: A phase 2, multicenter, single-arm study of retreatment with brentuximab vedotin in subjects with relapsed or refractory classical Hodgkin lymphoma (cHL) or peripheral T cell lymphoma (PTCL)

A retreatment study with brentuximab vedotin in subjects with classical Hodgkin lymphoma or peripheral T cell lymphoma whose cancer got better after taking brentuximab vedotin, and subsequently got worse. USM/BVM/2021/0037

Trial ID: NCT03947255

Trial Details

We want to learn if the study drug brentuximab vedotin can be used to retreat complete response (CR) or partial response (PR) patients with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma(sALCL) or Pripheral T cell lymphoma (PTCL).

Subjects enrolled would be treated every 3 weeks and Subjects may continue on treatment until disease progresses, unacceptable side effects, or study closure occurs.

Estimated Enrollment

80 Participants

Phase

Eligibility Criteria

Participants must:

18yrs or older
Have been diagnosed with Classical Hodgkin Lymphoma or Peripheral T-Cell Lymphoma
Have previously received treatment with brentuximab vedotin, (ADCETRIS) and the cancer got better
6 months of improvement before patient was told that their cancer had progressed (gotten worse) or had returned

Participants must not:

Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
Existing Grade 2 or higher peripheral neuropathy
Previously did not respond (improve) with treatment of brentuximab vedotin or responded (improved) but the duration of response was less than 6 months after taking Brentuximab Vedotin
Active cerebral/meningeal disease

What Will Happen in This Study

If you choose to take part in this study, your doctor will review your medical history, conduct a physical examination and do tests to see if you can be in the study. If you can be in the study and choose to take part, we will do tests to see if brentuximab vedotin can affect your disease. If your cancer stays the same or gets better, and you don’t have any serious problems, you can keep getting brentuximab vedotin.

You will need to travel to one of the study clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

What is a clinical trial?

Clinical trials are studies that test new ways to prevent, detect, diagnose, or treat health conditions. The goal of clinical trials is to find out if a new test or treatment works and is as safe as possible. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

People who take part in clinical trials help contribute to medical knowledge and to potentially improving cancer care.

What are the potential benefits of participating in a clinical trial?

The benefits of participating in a clinical trial may include:

Early access to investigational therapies that are generally not available outside of a clinical trial
Regular and careful medical attention from a research team that includes doctors, nurses, and other health professionals
Early access to more effective treatments, if the treatment being studied is shown to be better than standard therapy
Opportunity to help other people who need to be treated for the same or similar disease in the future
Chance to contribute to scientific understanding of a disease

What are the potential risks of participating in a clinical trial?

The risks of participating in a clinical trial may include:

The new treatment being studied may not be better than or as good as standard therapy
The new treatment being studied may have harmful side effects that doctors do not expect or that are worse than those associated with standard therapy
Health insurance may not cover all routine care costs in a trial

Will I have to pay to be in the study?

The study drug Brentuximab Vedotin will be provided by Seagen at no cost to you. Procedures that are done only for the study will be paid for by Seagen. You or your health insurance company will be billed for parts of the study that are standard care for your disease.

How can I check to see if I am eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Can I quit the study at any time?

Yes. You can decide to stop at any time, and you may still be treated at your hospital or clinic. The study doctor may also stop you from taking part in this study at any time if they think it is best for you, or if you do not follow the study rules. Your study doctor or Seagen may also decide to stop this study for medical or other reasons at any time. If you decide to stop study treatment, we will still ask you to come back to the hospital or clinic for end-of-treatment tests. We may also ask you to take part in the follow-up visits and/or phone calls. Follow-up visits and phone calls are important to make sure that there are no lasting side effects from study treatment. We also want to see if your cancer got better, stayed the same, or got worse after end of treatment.

What personal information is collected about me for the study?

Your study doctor and other study staff will collect your personal information. This may include:

Your name, address, telephone number, health insurance number where applicable.
Your age, and sex.
Lifestyle information; health and medical history.
Your current and past study treatments and response to study treatments.
Data resulting from testing your biological samples.
Data resulting from collection on a study device.
Data resulting from your responses collected in an electronic diary.

Who has access to my personal information?

The only people who will have access to the names of participants are the study site medical team and the travel assistance company. Each patient is given a unique study identifier number in order to protect their identity in the study. This is done to make sure that the study is being run properly.

All your responses to the survey questions and contact information will be stored securely in our database. No medical information will be collected nor filed. Sponsor staff, review boards, and ethics committees (who approve and oversee studies) will not receive any patient identifying information; this will remain our database

Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your study information that is specifically collected for and during your study participation as it relates to the study. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by TrialScope to contact you about clinical trials and related information.