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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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0
2012-002751-42
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Secondary ID [2]
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SGN35-014
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Universal Trial Number (UTN)
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Trial acronym
ECHELON-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anaplastic Large-Cell Lymphoma
0
0
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Non-Hodgkin Lymphoma
0
0
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T-Cell Lymphoma
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival Per Independent Review Facility (IRF)
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Assessment method [1]
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The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
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Timepoint [1]
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Up to 60 months
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Secondary outcome [1]
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Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
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Assessment method [1]
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The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
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Timepoint [1]
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Up to 60 months
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Secondary outcome [2]
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Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
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Assessment method [2]
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The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
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Timepoint [2]
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Up to 8.34 months
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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The time from randomization to death due to any cause.
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Timepoint [3]
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Up to 90 months
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Secondary outcome [4]
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Objective Response Rate (ORR) Per IRF at End of Treatment
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Assessment method [4]
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The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
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Timepoint [4]
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Up to 8.34 months
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Secondary outcome [5]
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Incidence of Adverse Events (AEs)
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Assessment method [5]
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Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
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Timepoint [5]
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Up to 8.28 months
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Secondary outcome [6]
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Incidence of Laboratory Abnormalities
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Assessment method [6]
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Number of participants who experienced a Grade 3 or higher laboratory toxicity.
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Timepoint [6]
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Up to 8.28 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/10/2020
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Sample size
Target
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Accrual to date
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Final
452
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Recruitment in Australia
Recruitment state(s)
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Royal Adelaide Hospital - Adelaide
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Moorabbin Hospital - Bentleigh East
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Icon Cancer Care Chermside - Chermside
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Icon Cancer Care South Brisbane - Chermside
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Icon Cancer Care Wesley - Chermside
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Monash Medical Centre - Clayton
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Concord Repatriation General Hospital - Concord
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St. Vincent's Hospital Sydney - Darlinghurst
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St Vincent's Public Hospital Sydney - Fitzroy - Fitzroy
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Western Hospital - Footscray
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Austin Health - Heidelberg
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Calvary Mater Newcastle - Waratah
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5000 - Adelaide
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3165 - Bentleigh East
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4032 - Chermside
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3168 - Clayton
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2139 - Concord
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2010 - Darlinghurst
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3065 - Fitzroy
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3011 - Footscray
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3084 - Heidelberg
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2298 - Waratah
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Seagen Inc.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Millennium Pharmaceuticals, Inc.
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01777152
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Public notes
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Contacts
Principal investigator
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Thomas Manley, MD
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Seagen Inc.
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01777152
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