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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01777152




Registration number
NCT01777152
Ethics application status
Date submitted
23/01/2013
Date registered
28/01/2013
Date last updated
30/11/2021

Titles & IDs
Public title
ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Secondary ID [1] 0 0
2012-002751-42
Secondary ID [2] 0 0
SGN35-014
Universal Trial Number (UTN)
Trial acronym
ECHELON-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaplastic Large-Cell Lymphoma 0 0
Non-Hodgkin Lymphoma 0 0
T-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 - doxorubicin
Treatment: Drugs - prednisone
Treatment: Drugs - vincristine
Treatment: Drugs - cyclophosphamide

Active comparator: CHOP - cyclophosphamide, doxorubicin, vincristine, and prednisone

Experimental: A+CHP - brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone


Treatment: Drugs: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles

Treatment: Drugs: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Treatment: Drugs: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles

Treatment: Drugs: vincristine
1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles

Treatment: Drugs: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival Per Independent Review Facility (IRF)
Timepoint [1] 0 0
Up to 60 months
Secondary outcome [1] 0 0
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
Timepoint [1] 0 0
Up to 60 months
Secondary outcome [2] 0 0
Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
Timepoint [2] 0 0
Up to 8.34 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to 90 months
Secondary outcome [4] 0 0
Objective Response Rate (ORR) Per IRF at End of Treatment
Timepoint [4] 0 0
Up to 8.34 months
Secondary outcome [5] 0 0
Incidence of Adverse Events (AEs)
Timepoint [5] 0 0
Up to 8.28 months
Secondary outcome [6] 0 0
Incidence of Laboratory Abnormalities
Timepoint [6] 0 0
Up to 8.28 months

Eligibility
Key inclusion criteria
* Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
* Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of another primary invasive malignancy that has not been in remission for at least 3 years
* Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
* History of progressive multifocal leukoencephalopathy (PML)
* Cerebral/meningeal disease related to the underlying malignancy

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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/10/2020
Sample size
Target
Accrual to date
Final
452
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Moorabbin Hospital - Bentleigh East
Recruitment hospital [3] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [4] 0 0
Icon Cancer Care South Brisbane - Chermside
Recruitment hospital [5] 0 0
Icon Cancer Care Southport - Chermside
Recruitment hospital [6] 0 0
Icon Cancer Care Wesley - Chermside
Recruitment hospital [7] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [9] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [10] 0 0
St Vincent's Public Hospital Sydney - Fitzroy - Fitzroy
Recruitment hospital [11] 0 0
Western Hospital - Footscray
Recruitment hospital [12] 0 0
Austin Health - Heidelberg
Recruitment hospital [13] 0 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
2139 - Concord
Recruitment postcode(s) [6] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3011 - Footscray
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
2298 - Waratah
Recruitment outside Australia
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Arizona
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Brno
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Odense C
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Créteil
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Pavia
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Verona
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Daegu
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Hwasun
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Seongnam-si
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Krakow
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Warsaw
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Romania
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Bucharest
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Bucuresti
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Cluj-Napoca
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Targu Mures
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Spain
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Barcelona
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L'Hospitalet de Llobregat
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León
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Madrid
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Majadahonda
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Salamanca
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Sevilla
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Spain
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Valencia
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taoyuan
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United Kingdom
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Cambridge
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Leicester
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London
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Manchester
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Newcastle upon Tyne
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United Kingdom
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Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Millennium Pharmaceuticals, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.
Trial website
https://clinicaltrials.gov/study/NCT01777152
Trial related presentations / publications
Savage KJ, Horwitz SM, Advani R, Christensen JH, Domingo-Domenech E, Rossi G, Morschhauser F, Alpdogan O, Suh C, Tobinai K, Shustov A, Trneny M, Yuen S, Zinzani PL, Trumper L, Ilidge T, O'Connor OA, Pro B, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Iyer S. Role of stem cell transplant in CD30+ PTCL following frontline brentuximab vedotin plus CHP or CHOP in ECHELON-2. Blood Adv. 2022 Oct 11;6(19):5550-5555. doi: 10.1182/bloodadvances.2020003971.
Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illes A, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Huttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trumper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. doi: 10.1016/S0140-6736(18)32984-2. Epub 2018 Dec 4. Erratum In: Lancet. 2019 Jan 19;393(10168):228. doi: 10.1016/S0140-6736(18)33123-4.
Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Manley, MD
Address 0 0
Seagen Inc.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01777152