Phase 3
Completed N=452
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
Source: ClinicalTrials.gov NCT01777152 ↗Enrolled (actual)
452
Serious AEs
39.9%
Results posted
Jul 2019
Primary outcomePrimary: Progression-free Survival Per Independent Review Facility (IRF) — 48.20; 20.80 months
◆ Published Evidence
Highly cited
721citations · ~103 / year
Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial.
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.
Linked Publications (5)
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Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial.
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Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study.
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Role of stem cell transplant in CD30+ PTCL following frontline brentuximab vedotin plus CHP or CHOP in ECHELON-2.
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Brentuximab vedotin plus chemotherapy for the treatment of front-line systemic anaplastic large cell lymphoma: subgroup analysis of the ECHELON-2 study at 5 years' follow-up.
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Association of PET4 response with outcomes of BV-CHP vs CHOP in the ECHELON-2 trial in CD30+ peripheral T-cell lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival Per Independent Review Facility (IRF) |
48.20; 20.80 | — |
| SECONDARY Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL) |
55.66; 32.03 | — |
| SECONDARY Complete Remission (CR) Rate Per IRF at End of Treatment (EOT) |
153; 126 | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Objective Response Rate (ORR) Per IRF at End of Treatment |
188; 163 | — |
| SECONDARY Incidence of Adverse Events (AEs) |
221; 221; 201; 193; 198; 205 | — |
| SECONDARY Incidence of Laboratory Abnormalities |
25; 23; 3; 1; 2; 3 | — |
Eligibility Criteria
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
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
Data sourced from ClinicalTrials.gov (NCT01777152) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.