A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01421667
First received: August 19, 2011
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).


Condition Intervention Phase
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Drug: brentuximab vedotin
Drug: rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective response rate with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Incidence of adverse events with brentuximab vedotin + rituximab [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities with brentuximab vedotin + rituximab [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse events with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Correlation between CD30 expression and antitumor activity with brentuximab vedotin [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Plasma concentration at end of infusion (Ceoi) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Pharmacodynamic (PD) biomarkers [ Time Frame: Pre-dose at each cycle ] [ Designated as safety issue: No ]
  • Objective response rate with brentuximab vedotin + rituximab [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Complete remission (CR) rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: August 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab vedotin+rituximab Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion
Experimental: Brentuximab vedotin Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed NHL (DLBCL only for Parts B and C)
  • Relapsed or refractory disease following at least 1 prior systemic therapy
  • Measurable disease of at least 1.5 cm as documented by CT
  • 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 systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
  • B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
  • Known cerebral/meningeal disease
  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: NCT01421667

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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Stephanie Biggers    205-975-2944    sbiggers@uab.edu   
Principal Investigator: Andres Forero-Torres, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010-3000
Contact: Cheryl Corpus    626-256-4673    ccorpus@coh.org   
Principal Investigator: Tanya Siddiqi         
PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists Recruiting
Oxnard, California, United States, 93030
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Lynn Kong, M.D.         
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5821
Contact: Sipra Choudhury    650-736-2563    schoudhury@stanford.edu   
Principal Investigator: Ranjana Advani, MD         
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: John M. Burke, M.D.         
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Juli Murphy    720-754-4890    Juli.Murphy@healthonecares.com   
Principal Investigator: Michael Maris, M.D.         
United States, Florida
Cancer Specialists of North Florida - St. Augustine Recruiting
St. Augustine, Florida, United States, 32086
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Marc Warmuth, M.D.         
United States, Georgia
Emory Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Vanessa Smith    404-778-3935    Vanessa.smith@emory.edu   
Principal Investigator: Mary Jo Lechowicz, M.D.         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Shyrell Robinson    773-702-0342    srobinso@medicine.bsd.uchicago.edu   
Principal Investigator: Chadi Nabhan, M.D.         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jose Zavala    312-695-4772    jose.zavala@northwestern.edu   
Principal Investigator: Jane Winter, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jad Bsat    617-582-9723    jbsat@partners.org   
Principal Investigator: Eric Jacobsen, MD         
United States, Minnesota
Minnesota Oncology Hematology P.A. Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Patrick Flynn, M.D.         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Molly Mees    314-362-4206    mmees@dom.wustl.edu   
Principal Investigator: Nancy Bartlett, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: James Sanchez         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Marisa Valentinetti    551-996-3277    mvalentinetti@HackensackUMC.org   
Principal Investigator: Tatyana Feldman, MD         
United States, New York
New York Oncology Hematology, P.C. Recruiting
Albany, New York, United States, 12206
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Lawrence Garbo, M.D.         
NYU Clinical Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Krysten Brown    212-263-4415    krysten.brown@nyumc.org   
Principal Investigator: Catherine Diefenbach, M.D.         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Sumi Nair    646-449-1305    nairs2@mskcc.org   
Principal Investigator: Steven Horwitz, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10019
Contact: Molly Patterson    212-326-5733    mp2621@columbia.edu   
Principal Investigator: Owen A. O'Connor, M.D.; PhD         
United States, Ohio
Cleveland Clinic, The Recruiting
Cleveland, Ohio, United States, 44195
Contact: Elizabeth Gazdick    216-445-8907    gazdice@ccf.org   
Principal Investigator: Mitchell Smith         
United States, Oregon
Willamette Valley Cancer and Research / USOR Recruiting
Eugene, Oregon, United States, 97401
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Jeff Sharman, M.D.         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Amanda Cameron    843-792-4486    cameroa@musc.edu   
Principal Investigator: Robert Stuart, M.D.         
St. Francis Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Kristina Stoeppler-Biege    864-255-1517    kristina_stoeppler-biege@bshsi.org   
Principal Investigator: Howland Crosswell, MD         
United States, Texas
Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Erica Goetz    214-818-8325    erica.goetz@baylorhealth.edu   
Principal Investigator: Edward Agura, M.D.         
Texas Oncology - Medical City Dallas Recruiting
Dallas, Texas, United States, 75230
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Michael Savin, M.D.         
Texas Oncology-Southwest Fort Worth Recruiting
Fort Worth, Texas, United States, 76132
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Cristi Aitelli, D.O.         
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4003
Contact: Linda Claret       LCClaret@mdanderson.org   
Principal Investigator: Yasuhiro Oki, M.D.         
Texas Oncology - Seton Williamson Recruiting
Round Rock, Texas, United States, 78665
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Vivian Cline-Burkhardt, M.D.         
Texas Oncology - Tyler Recruiting
Tyler, Texas, United States, 75702
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Donald Richards, M.D.         
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Dipti Patel-Donnelly, M.D.         
United States, Washington
Swedish Cancer Institute Medical Oncology Recruiting
Edmonds, Washington, United States, 98026
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: George Birchfield         
Seattle Cancer Care Alliance / University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98109
Contact: Leslie Braley    206-288-6854    lbraley@seattlecca.org   
Principal Investigator: Andrei Shustov, MD         
Northwest Cancer Specialists, P.C. Recruiting
Vancouver, Washington, United States, 98684
Contact: Christi Schany    281-863-6712    christi.schany@usoncology.com   
Principal Investigator: Kathryn Kolibaba, M.D.         
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Daphne Brockington    604-877-6000    dbrockington@bccancer.bc.ca   
Principal Investigator: Kerry Savage, M.D.         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Corinna Palanca-Wessels, MD, PhD Seattle Genetics, Inc.
  More Information

No publications provided by Seattle Genetics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01421667     History of Changes
Other Study ID Numbers: SGN35-012
Study First Received: August 19, 2011
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 01, 2014