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Monoclonal Antibodies

Brentuximab Vedotin + Lenalidomide + Rituximab for Diffuse Large B-Cell Lymphoma (ECHELON-3 Trial)

Phase 3
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you been diagnosed with diffuse large B-cell lymphoma (DLBCL)?
Have you not experienced a heart attack, stroke or blood clot in the past 6 months?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights

ECHELON-3 Trial Summary

This trial is studying whether adding brentuximab vedotin to standard treatment with rituximab and lenalidomide may work better in treating participants with DLBCL that has come back or has not gotten better with other treatment.

Eligible Conditions
  • Diffuse Large B-Cell Lymphoma

ECHELON-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with diffuse large B-cell lymphoma (DLBCL).
Select...
You have not had a heart attack, stroke, or blood clot in the last 6 months.
Select...
Your DLBCL did not get better with treatment or came back after treatment.
Select...
You have not been diagnosed with any other type of cancer in the last 2 years.
Select...
You don't have damage to the nerves in your arms or legs.
Select...
You have been treated for DLBCL with at least two different types of medication.

ECHELON-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Complete response (CR) rate
Duration of response (DOR)
Incidence of adverse events
+3 more

ECHELON-3 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental ArmExperimental Treatment3 Interventions
Brentuximab vedotin + lenalidomide + rituximab
Group II: Control ArmActive Control3 Interventions
Placebo + lenalidomide + rituximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
2012
Completed Phase 2
~200
Rituximab
1999
Completed Phase 4
~1880
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
68,932 Total Patients Enrolled
Evelyn Rustia, MDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
565 Total Patients Enrolled
Brandon Croft, PharmDStudy DirectorSeagen Inc.
3 Previous Clinical Trials
681 Total Patients Enrolled

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04404283 — Phase 3
Diffuse Large B-Cell Lymphoma Research Study Groups: Control Arm, Experimental Arm
Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT04404283 — Phase 3
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04404283 — Phase 3
Diffuse Large B-Cell Lymphoma Patient Testimony for trial: Trial Name: NCT04404283 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me how many different hospitals are participating in this clinical trial?

"Some of the twenty-four facilities where this study is being conducted are Florida Cancer Specialists - East West Palm Beach (SCRI) in West Palm Beach, Arizona Oncology Associates, PC - HAL in Phoenix, and Arizona, and Florida Cancer Specialists - East West Palm Beach, FL (SCRI) in Grosse Pointe Woods, Michigan."

Answered by AI

How many study subjects are you testing this on?

"400 individuals that fit the study's prerequisites are required to run the trial. The sponsor, Seagen Inc., will manage the trial from various sites including Florida Cancer Specialists - East West Palm Beach (SCRI) in West Palm Beach, Florida and Arizona Oncology Associates, PC - HAL in Phoenix, Arizona."

Answered by AI

What other research has been done on Brentuximab vedotin?

"Brentuximab vedotin was first trialled in 1993 at the National Institutes of Health Clinical Center. As of now, there have been a total of 19352 completed studies. Out of the 685 active trials, many are taking place in West Palm Beach, Florida."

Answered by AI

What are the risks associated with Brentuximab vedotin?

"Brentuximab vedotin is a Phase 3 trial drug, which means that there is both efficacy and safety data supporting its use. Our team rates its safety as a 3."

Answered by AI

Which type of cancer is Brentuximab vedotin most effective against?

"Brentuximab vedotin is an effective treatment for diffuse large b-cell lymphoma (DLBCL) as well as other B-cell lymphomas, provided that the patient has already undergone at least two rounds of systemic chemotherapy."

Answered by AI

Are investigators actively working to bring more participants into this research project?

"The clinical trial is still open and recruiting patients, according to the information available on clinicaltrials.gov. This trial was originally posted on 2020-08-20, and the most recent update was on 2022-10-28."

Answered by AI

What are the goals that researchers are hoping to achieve with this clinical trial?

"The primary outcome of this study, which will be monitored over a period of 1 year, is progression-free survival (PFS) in the CD30-positive population. Secondary objectives include the complete response (CR) rate, the objective response rate (ORR), and the duration of objective response."

Answered by AI

Who else is applying?

How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
New Hampshire
Virginia
Wisconsin
Other
What site did they apply to?
Arizona Oncology Associates, PC - HAL
Charleston Oncology
Other
University of Virginia
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I’d like to help gather a cure. I'm on Wait & See, this is Waldenstrom Luekemia.....
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Aurora Health Care, Inc: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
BloodJournal
Phase 1/dose Expansion Trial of Brentuximab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-cell Lymphoma
Ward, Jeffrey P., Melissa M. Berrien-Elliott, Felicia Gomez, Jingqin Luo, Michelle Becker-Hapak, Amanda F. Cashen, Nina D. Wagner-Johnston, et al.. 2022. “Phase 1/dose Expansion Trial of Brentuximab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-cell Lymphoma”. Blood. American Society of Hematology. doi:10.1182/blood.2021011894.
BloodJournal
Phase 1/dose Expansion Trial of Brentuximab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-cell Lymphoma
Ward, Jeffrey P., Melissa M. Berrien-Elliott, Felicia Gomez, Jingqin Luo, Michelle Becker-Hapak, Amanda F. Cashen, Nina D. Wagner-Johnston, et al.. 2022. “Phase 1/dose Expansion Trial of Brentuximab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-cell Lymphoma”. Blood. American Society of Hematology. doi:10.1182/blood.2021011894.
clinicaltrials.govStudy
Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL
2020. "Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04404283.
~48 spots leftby Apr 2025
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