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

Seagen

Status and phase: Completed; Phase 3

Conditions: T-Cell Lymphoma; Anaplastic Large-Cell Lymphoma; Non-Hodgkin Lymphoma

Treatments: Drug: doxorubicin; Drug: prednisone; Drug: cyclophosphamide; Drug: vincristine; Drug: brentuximab vedotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01777152

SGN35-014

2012-002751-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 452 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

452 participants in 2 patient groups

CHOP

Active Comparator group

Description:

cyclophosphamide, doxorubicin, vincristine, and prednisone

Treatment:

Drug: doxorubicin

Drug: cyclophosphamide

Drug: vincristine

Drug: prednisone

A+CHP

Experimental group

Description:

brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone

Treatment:

Drug: doxorubicin

Drug: brentuximab vedotin

Drug: cyclophosphamide

Drug: prednisone