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Completed

NCT Number: NCT01777152

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

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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Key information

Conditions

Anaplastic Large-Cell Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin Lymphoma T-cell Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Adelaide Hospital, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brentuximab Vedotin

Drug

1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles

Other names: Adcetris; SGN-35

Doxorubicin

Drug

50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Prednisone

Drug

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

Vincristine

Drug

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

Cyclophosphamide

Drug

750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Primary outcomes

  1. Progression-free Survival Per Independent Review Facility (IRF)

    Time frame: 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 outcomes

  1. Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)

    Time frame: 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.

  2. Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)

    Time frame: 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.

  3. Overall Survival (OS)

    Time frame: Up to 90 months

    The time from randomization to death due to any cause.

  4. Objective Response Rate (ORR) Per IRF at End of Treatment

    Time frame: 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.

  5. Incidence of Adverse Events (AEs)

    Time frame: 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.

  6. Incidence of Laboratory Abnormalities

    Time frame: Up to 8.28 months

    Number of participants who experienced a Grade 3 or higher laboratory toxicity.

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study 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

Acronym: ECHELON-2

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Jan 28, 2013
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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