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

Phase 3

Completed

• Conditions: T-Cell Lymphoma; Anaplastic Large-Cell Lymphoma; Non-Hodgkin Lymphoma
• Interventions: Drug: doxorubicin; Drug: brentuximab vedotin; Drug: prednisone; Drug: vincristine; Drug: cyclophosphamide

• Registration Number: NCT01777152
• Lead Sponsor: Seagen Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-28
• Study Start: 2013-01-31
• Primary Completion: 2018-08-15
• Results First Submitted: 2019-07-10
• Results First Submitted QC: 2019-07-10
• Results First Posted: 2019-07-30
• Study Completion: 2020-10-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHOP	vincristine	cyclophosphamide, doxorubicin, vincristine, and prednisone
CHOP	doxorubicin	cyclophosphamide, doxorubicin, vincristine, and prednisone
CHOP	prednisone	cyclophosphamide, doxorubicin, vincristine, and prednisone
CHOP	cyclophosphamide	cyclophosphamide, doxorubicin, vincristine, and prednisone
A+CHP	doxorubicin	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
A+CHP	cyclophosphamide	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
A+CHP	brentuximab vedotin	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
A+CHP	prednisone	brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone

Primary Outcome Measures

Name	Time	Method
Progression-free Survival Per Independent Review Facility (IRF)	Up to 60 months	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)	Up to 60 months	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.
Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)	Up to 8.34 months	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.
Overall Survival (OS)	Up to 90 months	The time from randomization to death due to any cause.
Objective Response Rate (ORR) Per IRF at End of Treatment	Up to 8.34 months	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.
Incidence of Adverse Events (AEs)	Up to 8.28 months	Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Incidence of Laboratory Abnormalities	Up to 8.28 months	Number of participants who experienced a Grade 3 or higher laboratory toxicity.

Trial Locations

Locations (144)

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

Shands Cancer Center / University of Florida; 🇺🇸 Gainesville, Florida, United States

Orlando Health, Inc.; 🇺🇸 Orlando, Florida, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Cardinal Bernardin Cancer Center / Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Holden Comprehensive Cancer Center / University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

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