Clinical Connection
Language:

ECHELON-3

The purpose of this clinical research study is to test the drug brentuximab vedotin combined with lenalidomide and rituximab in patients with diffuse large B-cell lymphoma (DLBCL) that did not get better or that came back after treatment compared to treatment with lenalidomide and rituximab. USM/BVM/2021/0043

Trial ID: NCT04404283

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 patients with DLBCL will be randomized into two groups. There will be about 200 subjects in each group.

  • One group will get brentuximab vedotin with the drugs lenalidomide and rituximab
  • One group will get a placebo with lenalidomide and rituximab. 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

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
  • Not be eligible for stem cell transplant (SCT) or chimeric antigen receptor T-cell (CAR-T) therapy
  • 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

Check Eligibility

We'll check to see if you are eligible by asking you some questions.

Get Started

What Will Happen in This Study

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.
  • 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 rituximab by IV infusion on the first day of each 21-day study cycle. After the first study cycle, you may receive rituximab by injection under the skin.
    • The study doctor will give you lenalidomide 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 rituximab):
    • 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.

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)

Check Eligibility

We'll check to see if you are eligible by asking you some questions.

Get Started