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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)

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ClinicalTrials.gov Identifier: NCT01777152
Recruitment Status : Active, not recruiting
First Posted : January 28, 2013
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : January 2013
Actual Primary Completion Date : August 15, 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Complete remission rate per IRF at end of treatment [ Time Frame: Through 1 month following last dose ]
  3. Overall survival [ Time Frame: Until death or study closure, up to 7 years post-treatment ]
  4. Objective response rate per IRF at end of treatment [ Time Frame: Through 1 month following last dose ]
  5. Type, incidence, severity, seriousness, and relatedness of adverse events [ Time Frame: Through 1 month following last dose ]
  6. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01777152     History of Changes
Other Study ID Numbers: SGN35-014
2012-002751-42 ( EudraCT Number )
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Prednisone
 Vincristine
Antibodies
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors