Policy Lab

This trial is not actively recruiting.

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

A phase 2 open-label study of brentuximab vedotin in front-line therapy of Hodgkin Lymphoma (HL) in patients with significant comorbidities who are ineligible to be treated with standard chemotherapy

This trial will study brentuximab vedotin (BV) (Part E), to find out whether it is an effective treatment for Hodgkin Lymphoma. Patients in this study will have other conditions that make them unable to receive standard chemotherapy treatment.

Trial ID: NCT01716806

Trial Details

We want to learn if the study drug brentuximab vedotin (BV) can be used to treat patients who have Hodgkin Lymphoma, have not received any prior treatments and are not able to receive multiagent chemotherapy. BV is designed to find and stick to certain cells and prevent the cancer from growing. In this part of the study, Part E, Seagen wants to find out if BV alone is safe, effective, and how well it is tolerated.

This is an open-label study. That means both you and the study team will know which study drug(s) you are getting.

[USM/BVM/2021/0016]

Estimated Enrollment

50 Participants

Phase

Eligibility Criteria

Participants must:

Be 18 years of age or older (Adult, Older Adult)
Have Hodgkin Lymphoma with measurable disease on imaging
Be unsuitable or unfit for initial standard combination chemotherapy

Participants must not:

Have had a severe viral bacterial or fungal infection within 2 weeks of the first dose of brentuximab vedotin
Have had another cancer within 1 year
Have cancer that has spread to your brain or spinal cord
Be receiving treatment with another experimental or clinical trial drug at the same time

What Will Happen in This Study

What’s Involved

If you choose to take part in this study, we’ll do tests to see if you can be in the study. If you can be in the study and choose to take part, we’ll do tests to see if the study drug can affect your cancer. If your cancer stays the same or gets better, and you don’t have any serious problems, you can keep getting the study drug for up to 16 cycles.

We will take blood samples for safety and research tests and to check on your disease. These are extra blood samples just for the study. You will also get blood drawn for your normal medical care.

The study doctor will review your medical history and complete one or two tools to determine if you are not able to receive standard chemotherapy treatment.

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)

Will I get paid to be a part of this clinical trial?

No, you will not be paid for taking part in this study. You may be able to have some of your travel costs for taking part in the study paid back, like mileage and lodging. We may also be able to give you a small amount of money for the time you spend taking part in the study. Please ask someone from the study staff for more information.

How can I check to see if I’m 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. If you pre-qualify the study doctor will further evaluate your eligibility.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new treatments. A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications. The trial may compare a new medical approach to a standard treatment option already available. The trial team will share more details before you participate.

Can I quit the trial at any time?

Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the participant’s safety, or if the participant no longer meets the study requirements.

What personal information is collected about you for the study?

The 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, sex, ethnic and racial background.
Health and medical history.
Your study treatments and response to study treatments.
Data resulting from testing your biological samples.

Who has access to your personal information?

All your personal information collected for this study will be securely stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others who have a need to know such as our data hosting provider, and government regulators may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. 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.