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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04404283




Registration number
Help: Registration number
NCT04404283
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
21/05/2020
Date registered
Help: Date registered
27/05/2020
Date last updated
Help: Date last updated
26/08/2025

Titles & IDs
Public title
Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL
Scientific title
A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Secondary ID [1] 0 0
C5691003
Secondary ID [2] 0 0
SGN35-031
Universal Trial Number (UTN)
Trial acronym
ECHELON-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brentuximab vedotin
Treatment: Drugs - Rituximab
Treatment: Drugs - Lenalidomide
Other interventions - Placebo

Experimental: Experimental Arm - Brentuximab vedotin + lenalidomide + rituximab

Active comparator: Control Arm - Placebo + lenalidomide + rituximab


Treatment: Drugs: Brentuximab vedotin
1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeks

Treatment: Drugs: Rituximab
375 mg/m\^2 administered via intravenous infusion on Cycle 1 Day 1. 1400 mg injected under the skin (subcutaneous) permitted every 3 weeks from Cycle 2 Day 1 through end of treatment.

Treatment: Drugs: Lenalidomide
20 mg given by mouth (orally) daily

Other interventions: Placebo
Administered via intravenous infusion every 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Approximately 1 year
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Approximately 1 year
Secondary outcome [3] 0 0
Complete response (CR) rate
Timepoint [3] 0 0
Approximately 1 year
Secondary outcome [4] 0 0
Duration of response (DOR)
Timepoint [4] 0 0
Approximately 1 year
Secondary outcome [5] 0 0
Incidence of adverse events
Timepoint [5] 0 0
Approximately 1 year
Secondary outcome [6] 0 0
OS in CD30+ participants
Timepoint [6] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
* Participants with relapsed or refractory diffuse and transformed large B-cell lymphoma (R/R DLBCL). DLBCL and cell of origin (GCB versus non-GCB) will be histologically determined by local pathology assessment for the purposes of study eligibility and stratification.
* Participants must have R/R disease following 2 or more lines of prior systemic therapy.

* For participants with transformed DLBCL, at least the last systemic therapy used must have been for DLBCL
* Participants must be HSCT or CAR-T ineligible according to the investigator and must meet at least one of the following criteria:

1. One or more co-morbidities, including cardiac, pulmonary, renal or hepatic dysfunction that in the opinion of the Investigator make the participant medically unfit to received HSCT or CAR-T therapy
2. Active disease following induction and salvage chemotherapy
3. Inadequate stem cell mobilization (for HSCT)
4. Relapse following prior HSCT or CAR-T
5. Unable to receive CAR-T therapy due to financial, geographic, insurance, or manufacturing issues
* Participants must have tumor tissue submitted to the central pathology lab. The tumor tissue submitted should be from the most recent biopsy that contains DLBCL.
* An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* Participants must have fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and bidimensional measurable disease of at least 1.5 cm by computed tomography (CT), as assessed by the site radiologist within 28 days of Day 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of another malignancy within 2 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy
* History of progressive multifocal leukoencephalopathy (PML)
* Active cerebral/meningeal disease related to the underlying malignancy. Participants with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been effectively treated and without progression for at least 3 months.
* Any uncontrolled Grade 3 or higher (per NCI CTCAE version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted
* Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 3 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
* Previous treatment with brentuximab vedotin or lenalidomide.

* Previous treatment with other vedotin-based ADCs is permitted if the last dose is at least 6 months prior to Day 1.
* Current therapy with immunosuppressive medications (including steroids), other systemic anti-neoplastic, or investigational agents

a) Prednisone (or equivalent) =10 mg/day may be used for non-lymphomatous purposes
* Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to the first dose of study drugs
* Congestive heart failure, Class III or IV, by the NYHA criteria
* Grade 2 or higher peripheral sensory or motor neuropathy at baseline

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/11/2025
Actual
Sample size
Target
Accrual to date
Final
239
Recruitment in Australia
Recruitment state(s)
NSW,TAS,WA
Recruitment hospital [1] 0 0
Central Coast Local Health District, Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Central Coast Local Health District Wyong Hospital - Hamlyn Terrace
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
Breakthrough Haematology Hollywood Specialist Centre - Nedlands
Recruitment hospital [5] 0 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Bellberry Limited - Eastwood
Recruitment hospital [8] 0 0
Ramsay National Research Unit and Research Governance Office - Greenslopes
Recruitment hospital [9] 0 0
Tasmania Health and Medical HREC - Hobart
Recruitment hospital [10] 0 0
Hollywood Haematology - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
- Eastwood
Recruitment postcode(s) [7] 0 0
- Greenslopes
Recruitment postcode(s) [8] 0 0
- Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Belgium
State/province [13] 0 0
Other
Country [14] 0 0
Belgium
State/province [14] 0 0
Antwerp
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Ghent
Country [17] 0 0
Belgium
State/province [17] 0 0
Haine-Saint-Paul
Country [18] 0 0
Belgium
State/province [18] 0 0
Yvoir
Country [19] 0 0
Canada
State/province [19] 0 0
Newfoundland and Labrador
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Czechia
State/province [23] 0 0
Hradec Králové
Country [24] 0 0
Denmark
State/province [24] 0 0
Aalborg
Country [25] 0 0
Denmark
State/province [25] 0 0
Aarhus C
Country [26] 0 0
Denmark
State/province [26] 0 0
Aarhus N
Country [27] 0 0
Denmark
State/province [27] 0 0
Copenhagen
Country [28] 0 0
Denmark
State/province [28] 0 0
Roskilde
Country [29] 0 0
France
State/province [29] 0 0
Other
Country [30] 0 0
France
State/province [30] 0 0
Angers
Country [31] 0 0
France
State/province [31] 0 0
Bordeaux
Country [32] 0 0
France
State/province [32] 0 0
Chambéry
Country [33] 0 0
France
State/province [33] 0 0
Corbeil-Essonnes
Country [34] 0 0
France
State/province [34] 0 0
Grenoble
Country [35] 0 0
France
State/province [35] 0 0
Le Mans
Country [36] 0 0
France
State/province [36] 0 0
Limoges
Country [37] 0 0
France
State/province [37] 0 0
Metz
Country [38] 0 0
France
State/province [38] 0 0
Nantes
Country [39] 0 0
France
State/province [39] 0 0
Nice
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
France
State/province [41] 0 0
Perpignan
Country [42] 0 0
France
State/province [42] 0 0
Pessac
Country [43] 0 0
France
State/province [43] 0 0
Pierre-Bénite
Country [44] 0 0
France
State/province [44] 0 0
Rouen
Country [45] 0 0
France
State/province [45] 0 0
Tours
Country [46] 0 0
France
State/province [46] 0 0
Vandœuvre-lès-Nancy
Country [47] 0 0
France
State/province [47] 0 0
Villejuif
Country [48] 0 0
Ireland
State/province [48] 0 0
Other
Country [49] 0 0
Italy
State/province [49] 0 0
Apulia
Country [50] 0 0
Italy
State/province [50] 0 0
Lecce
Country [51] 0 0
Italy
State/province [51] 0 0
MI
Country [52] 0 0
Italy
State/province [52] 0 0
Other
Country [53] 0 0
Italy
State/province [53] 0 0
Trieste
Country [54] 0 0
Poland
State/province [54] 0 0
Krakow
Country [55] 0 0
Poland
State/province [55] 0 0
Torun
Country [56] 0 0
South Korea
State/province [56] 0 0
Gyeonggi-do
Country [57] 0 0
South Korea
State/province [57] 0 0
Jeollabuk-do
Country [58] 0 0
South Korea
State/province [58] 0 0
Busan
Country [59] 0 0
South Korea
State/province [59] 0 0
Daegu
Country [60] 0 0
South Korea
State/province [60] 0 0
Incheon
Country [61] 0 0
South Korea
State/province [61] 0 0
Seoul
Country [62] 0 0
Spain
State/province [62] 0 0
Extremadura
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Malaga
Country [65] 0 0
Spain
State/province [65] 0 0
Navarre
Country [66] 0 0
Spain
State/province [66] 0 0
Other
Country [67] 0 0
Spain
State/province [67] 0 0
Badajoz
Country [68] 0 0
Spain
State/province [68] 0 0
Barcelona
Country [69] 0 0
Spain
State/province [69] 0 0
Cáceres
Country [70] 0 0
Spain
State/province [70] 0 0
Málaga
Country [71] 0 0
Spain
State/province [71] 0 0
Móstoles
Country [72] 0 0
Spain
State/province [72] 0 0
Pozuelo de Alarcon (madrid )
Country [73] 0 0
Spain
State/province [73] 0 0
Pozuelo de Alarcon (madrid)
Country [74] 0 0
Spain
State/province [74] 0 0
Salamanca
Country [75] 0 0
Switzerland
State/province [75] 0 0
Canton of Zurich
Country [76] 0 0
Switzerland
State/province [76] 0 0
Other
Country [77] 0 0
Switzerland
State/province [77] 0 0
Basel
Country [78] 0 0
Switzerland
State/province [78] 0 0
Schlieren
Country [79] 0 0
Switzerland
State/province [79] 0 0
Winterthur
Country [80] 0 0
Taiwan
State/province [80] 0 0
R.o.c
Country [81] 0 0
Taiwan
State/province [81] 0 0
Kaohsiung City
Country [82] 0 0
Taiwan
State/province [82] 0 0
Tainan City
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taoyuan District
Country [85] 0 0
United Kingdom
State/province [85] 0 0
WEST Midlands
Country [86] 0 0
United Kingdom
State/province [86] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen, a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04404283