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 study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Seattle Genetics, Inc.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01777152
First received: January 23, 2013
Last updated: September 30, 2014
Last verified: September 2014
  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
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Drug: brentuximab vedotin
Drug: doxorubicin
Drug: prednisone
Drug: vincristine
Drug: cyclophosphamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Complete remission rate per IRF at end of treatment [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until death or study closure, up to 7 years post-treatment ] [ Designated as safety issue: No ]
  • Objective response rate per IRF at end of treatment [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Type, incidence, severity, seriousness, and relatedness of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
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
Genders Eligible for Study:   Both
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

Contacts
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

  Show 138 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Thomas Manley, MD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01777152     History of Changes
Other Study ID Numbers: SGN35-014
Study First Received: January 23, 2013
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma
Lymphoma, Non-Hodgkin
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, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014