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

• ClinicalTrials.gov Identifier: NCT00947856
• Recruitment Status: Completed
• First Posted: July 28, 2009
• Results First Posted: May 26, 2014
• Last Update Posted: February 2, 2017
• Sponsor: Seagen Inc.
• Collaborator: Millennium Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Seagen Inc.

Tracking Information

• First Submitted Date: July 24, 2009
• First Posted Date: July 28, 2009
• Results First Submitted Date: March 21, 2014
• Results First Posted Date: May 26, 2014
• Last Update Posted Date: February 2, 2017
• Study Start Date: July 2009
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 30, 2014)

• Objective Response Rate by Investigator [ Time Frame: Up to approximately 38 months ]
  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.
• Adverse Events by Severity, Seriousness, and Relationship to Treatment [ Time Frame: up to 39 months ]
  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.
• Laboratory Abnormalities >/= Grade 3 [ Time Frame: Up to 39 months ]
  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.

Original Primary Outcome Measures (submitted: July 24, 2009)

• Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month post last dose ]
• Best clinical response [ Time Frame: Every 2 to 3 months ]

Current Secondary Outcome Measures (submitted: April 30, 2014)

• Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: Up to 38 months ]
  Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death
• Progression-free Survival by Kaplan-Meier Analysis [ Time Frame: Up to approximately 29 months ]
  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
• Overall Survival [ Time Frame: Up to approximately 41 months ]
  Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause
• Incidence of Antitherapeutic Antibodies [ Time Frame: Up to 39 months ]
  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

Original Secondary Outcome Measures (submitted: July 24, 2009)

• Duration of response, progression-free survival, and overall survival [ Time Frame: Every 3 months until death or study closure ]
• Incidence of antitherapeutic antibodies [ Time Frame: Up to 1 month post last dose ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
• Official Title: Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study
• Brief Summary: 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.

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
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Disease, Hodgkin
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin

Intervention

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 Name: Adcetris

Study Arms

• Experimental: BV Retreatment
  Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
  Intervention: Drug: brentuximab vedotin
• Experimental: BV Extension
  Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
  Intervention: Drug: brentuximab vedotin

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 30, 2014): 110
• Original Estimated Enrollment (submitted: July 24, 2009): 50
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, United States

Administrative Information

• NCT Number: NCT00947856
• Other Study ID Numbers: SGN35-006; 2010-019932-11 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Seagen Inc.
• Original Responsible Party: Laurie Grove, PA-C, Seattle Genetics, Inc.
• Current Study Sponsor: Seagen Inc.
• Original Study Sponsor: Same as current
• Collaborators: Millennium Pharmaceuticals, Inc.

Investigators

• Study Director: Laurie Grove, PA-C; Seagen Inc.

• PRS Account: Seagen Inc.
• Verification Date: December 2016