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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947856
• Other study ID #: SGN35-006
• Secondary ID: 2010-019932-11
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2009
• Last updated: November 17, 2015
• Start date: July 2009
• Est. completion date: March 2013

Study information

• Verified date: May 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease, Hodgkin
• Hodgkin Disease
• Lymphoma
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  France, 

References & Publications (1)

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 H — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes