ECHELON-3

Trial ID: NCT04404283

The purpose of this clinical research study is to test the study drug with standard of care therapies, in patients with diffuse large B-cell lymphoma (DLBCL) that did not get better or that came back after treatment compared to treatment with standard of care therapies alone. USM/BVM/2021/0043

Prescreen Now

Seagen is dedicated to our goal of ensuring that all patients are represented in our clinical trials. It is important to Seagen that the therapies we make improve the lives of all people with cancer, including those who have been historically underrepresented due to their sex, race, ethnicity, or age. — Seagen Commitment to Diversity & Inclusion

Trial Details

In the ECHELON-3 study, about 400 participants with DLBCL will be randomized into two groups.

One group will get the study drug with a standard of care medication
One group will get a placebo with a standard of care medication. A placebo has no real drug in it.

The group you are in will be chosen randomly, like tossing a coin. Neither you nor the study team will know which group you are in until the end of the study.

Estimated Enrollment

400 Participants

Phase

Phase 3

Eligibility Criteria

Participants must:

Be age 18 or older
Have diffuse large B-cell lymphoma (DLBCL) that did not respond to treatment or that came back after treatment after two or more previous types of treatment
Have one of the following types of DLBCL:
- Not otherwise specified (NOS)
- Intravascular large B-cell lymphoma
- DLBCL associated with chronic inflammation
- EBV-positive NOS
- ALK-positive
- T-cell-/histiocyte-rich large B-cell lymphoma
- Primary mediastinal large B-cell lymphoma
- High-grade B-cell lymphoma with translocations of MYC and BCL2 or BCL6 (double-/triple-hit lymphoma)
- High-grade NOS B-cell lymphomas
- Primary cutaneous DLBCL (leg type)
- DLBCL arising from transformed indolent lymphomas/leukemias

Participants must not:

Have a history of another type of cancer within 2 years of starting the study, or any evidence of a previously diagnosed cancer. Exceptions may include: stage 0 cervical cancer, non-melanoma skin cancer, localized prostate cancer, stage 0 breast cancer or stage I uterine cancer
Have a history of progressive multifocal leukoencephalopathy (PML)
Have active cerebral/meningeal disease related to the cancer
Have an uncontrolled viral, bacterial or fungal infection within 2 weeks of starting the study drug
Have had chemotherapy, radiation, biologics or other type of immunotherapy to treat cancer within 3 weeks before starting the study drug

What Will Happen in This Study

Please select the closest site to you and Seagen will work with you to access travel and lodging support.

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

Study participation may last up to 5 years, and the study is divided into the following periods:

Screening Period (up to 4 weeks):
- You will have some tests and procedures to see if you are eligible for the study.
- These tests will be done during one or more office visits.
Study Treatment Period (21-day study cycles):
- You will receive the investigational drug or a placebo into your arm by an intravenous (IV) infusion on the first day of each 21-day study cycle.
- You will receive a standard of care therapy by IV infusion on the first day of each 21-day study cycle. After the first study cycle, you may receive standard of care therapy by injection under the skin.
- The study doctor will give you another standard of care therapy by pill to take at home once a day.
- The study cycles may continue for as long as your cancer is stable or getting better.
End-of-Treatment Visit (30 days after last treatment):
- During this visit, you will have some tests and answer questions about your cancer.
Safety Visit (3 to 4 months after last dose of SOC Therapy):
- During this visit, you will have some tests and answer questions about your cancer.
Long-term Follow-up Period (ongoing):
- After the Safety Visit, you will have follow-up visits or phone calls every 3 months for about a year, and then every 6 months after that.

Frequently Asked Questions (FAQs)

Will I have to pay to be in the study?

The study drug 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.

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 possible benefits of participating?

The possible benefits of participating in a clinical trial may include:

Regular and careful study-related medical attention from a research team that includes doctors, nurses, and other health professionals
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 possible risks of participating?

The possible risks of participating in a clinical trial may include:

The new investigational treatment being studied may not be better than or as good as standard therapy
The new investigational 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

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

You can complete a set of pre-screening questions to see if you might qualify to take part in this study. You can find these on this web page by clicking the ‘Get Started’ button. You can also discuss this with your doctor if you are unsure about any of the qualifying criteria for the study.

Can I quit the trial 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 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 ask you to come back to the hospital or clinic for end-of-treatment tests. We may also ask you to take part in follow-up visits and/or phone calls. Follow-up visits and phone calls are important to make sure 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. The study doctor or sponsor also has the right to discontinue a participant at any time for the participant’s safety, or if the participant no longer meets the study requirements.

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.