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Trial record 1 of 1 for:    NCT01777152
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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 (ECHELON-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01777152
First received: January 23, 2013
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Anaplastic Large-Cell Lymphoma Non-Hodgkin Lymphoma T-Cell Lymphoma Drug: brentuximab vedotin Drug: doxorubicin Drug: prednisone Drug: vincristine Drug: cyclophosphamide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Progression-free survival per independent review facility (IRF) [ Time Frame: Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post-treatment ]

Secondary Outcome Measures:
  • Progression-free survival per IRF in patients with systemic anaplastic large cell lymphoma (sALCL) [ Time Frame: Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post-treatment ]
  • Complete remission rate per IRF at end of treatment [ Time Frame: Through 1 month following last dose ]
  • Overall survival [ Time Frame: Until death or study closure, up to 7 years post-treatment ]
  • Objective response rate per IRF at end of treatment [ Time Frame: Through 1 month following last dose ]
  • Type, incidence, severity, seriousness, and relatedness of adverse events [ Time Frame: Through 1 month following last dose ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]

Enrollment: 452
Study Start Date: January 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
Drug: vincristine
1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Experimental: A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
Other Name: Adcetris; SGN-35
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777152

  Show 144 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Thomas Manley, MD Seattle Genetics, Inc.
  More Information

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01777152     History of Changes
Other Study ID Numbers: SGN35-014
2012-002751-42 ( EudraCT Number )
Study First Received: January 23, 2013
Last Updated: February 9, 2017

Keywords provided by Seattle Genetics, Inc.:
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Lymphoma
Monomethyl auristatin E
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vincristine
Liposomal doxorubicin
Doxorubicin
Prednisone
Cyclophosphamide
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on June 27, 2017