A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study

This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.

Study Overview

• Status: Completed
• Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; Disease, Hodgkin
• Intervention / Treatment: Drug: brentuximab vedotin

Detailed Description

This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:

• Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
• Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• France
  • Cedex 10
    • Paris, Cedex 10, France, 75475
      • Hopital Saint-Louis/Service d'Hematologie
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3300
      • University of Alabama at Birmingham
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Stanford, California, United States, 94305
      • Stanford Cancer Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center - Cardinal Bernadin Cancer Center
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • St. Francis Medical Group Oncology & Hematology Specialists
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute / Wayne State University
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • The John Theurer Cancer Center, Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10016
      • NYU Clinical Cancer Center
    • New York, New York, United States, 10019
      • Columbia University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Texas
    • Dallas, Texas, United States, 75246
      • Charles A. Sammons Cancer Center
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center /The University of Texas
  • Washington
    • Seattle, Washington, United States, 98109-1023
      • Seattle Cancer Care Alliance / University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participated in a previous brentuximab vedotin study.
• CD30-positive hematologic malignancy.
• At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.

Exclusion Criteria:

Withdrew consent to participate in any prior brentuximab vedotin study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BV Retreatment; Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)	Drug: brentuximab vedotin; Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure; Other Names: Adcetris
EXPERIMENTAL: BV Extension; Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)	Drug: brentuximab vedotin; Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure; Other Names: Adcetris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate by Investigator	Percentage of participants in the retreatment arm who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.	Up to approximately 38 months
Adverse Events by Severity, Seriousness, and Relationship to Treatment	Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.	up to 39 months
Laboratory Abnormalities >/= Grade 3	Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.	Up to 39 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Objective Response by Kaplan-Meier Analysis	Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death	Up to 38 months
Progression-free Survival by Kaplan-Meier Analysis	Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause	Up to approximately 29 months
Overall Survival	Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause	Up to approximately 41 months
Incidence of Antitherapeutic Antibodies	Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment	Up to 39 months

Collaborators and Investigators

• Sponsor: Seagen Inc.
• Collaborators: Millennium Pharmaceuticals, Inc.
• Investigators: Study Director: Laurie Grove, PA-C, Seagen Inc.

Publications and helpful links

General Publications

• Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. doi: 10.1186/1756-8722-7-24.
• Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: July 24, 2009
• First Submitted That Met QC Criteria: July 24, 2009
• First Posted (ESTIMATE): July 28, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 2, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Drug Therapy; Immunotherapy; Hematologic Diseases; Antibody-Drug Conjugate; Antibodies, Monoclonal; Monomethylauristatin E; Antigens, CD30
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, T-Cell; Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; Antineoplastic Agents; Antineoplastic Agents, Immunological; Brentuximab Vedotin
• Other Study ID Numbers: SGN35-006; 2010-019932-11 (EUDRACT_NUMBER)