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

NCT01421667 | Completed Phase 2 Results

• 1 other identifier: SGN35-012
• Study Type: interventional
• Target: 176
• Locations: 2 countries
• Sites: 34

Brief Summary

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).

Conditions

Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy

  Percentage of participants treated with brentuximab vedotin monotherapy 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 3 years

• Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab

  Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). 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 3 years

Secondary Outcomes (12)

• Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab

  Up to approximately 3 years

• Complete Remission (CR) Rate by Investigator

  Up to approximately 3 years

• Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis

  Up to approximately 3 years

• Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis

  Up to approximately 3 years

• Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis

  Up to approximately 3 years

Study Arms (2)

Brentuximab vedotin+rituximab

EXPERIMENTAL

Drug: brentuximab vedotin; Drug: rituximab

Brentuximab vedotin

EXPERIMENTAL

Drug: brentuximab vedotin

Interventions

brentuximab vedotin DRUG

1.8 mg/kg every 3 weeks by IV infusion

Also known as: Adcetris; SGN-35

Brentuximab vedotin; Brentuximab vedotin+rituximab

rituximab DRUG

375 mg/m2 every 3 weeks by IV infusion

Brentuximab vedotin+rituximab

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

You may not qualify if:

• 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

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (34)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

City of Hope

Duarte, California, 91010-3000, United States

Location

PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists

Oxnard, California, 93030, United States

Location

Stanford Cancer Center

Stanford, California, 94305-5821, United States

Location

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, 80012, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Cancer Specialists of North Florida - St. Augustine

Saint Augustine, Florida, 32086, United States

Location

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637-1470, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Minnesota Oncology Hematology P.A.

Minneapolis, Minnesota, 55404, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

Location

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10019, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Cleveland Clinic, The

Cleveland, Ohio, 44195, United States

Location

Willamette Valley Cancer and Research / USOR

Eugene, Oregon, 97401, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

St. Francis Hospital

Greenville, South Carolina, 29605, United States

Location

Texas Oncology - Medical City Dallas

Dallas, Texas, 75230, United States

Location

Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology-Southwest Fort Worth

Fort Worth, Texas, 76132, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030-4003, United States

Location

Texas Oncology - Seton Williamson

Round Rock, Texas, 78665, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Swedish Cancer Institute Medical Oncology

Edmonds, Washington, 98026, United States

Location

Seattle Cancer Care Alliance / University of Washington Medical Center

Seattle, Washington, 98109, United States

Location

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98684, United States

Location

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (3)

• Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. doi: 10.1182/blood-2013-12-542142. Epub 2014 Mar 20.

  PMID: 24652992 RESULT

• Jacobsen ED, Sharman JP, Oki Y, Advani RH, Winter JN, Bello CM, Spitzer G, Palanca-Wessels MC, Kennedy DA, Levine P, Yang J, Bartlett NL. Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression. Blood. 2015 Feb 26;125(9):1394-402. doi: 10.1182/blood-2014-09-598763. Epub 2015 Jan 8.

  PMID: 25573987 RESULT

• Bartlett NL, Smith MR, Siddiqi T, Advani RH, O'Connor OA, Sharman JP, Feldman T, Savage KJ, Shustov AR, Diefenbach CS, Oki Y, Palanca-Wessels MC, Uttarwar M, Li M, Yang J, Jacobsen ED. Brentuximab vedotin activity in diffuse large B-cell lymphoma with CD30 undetectable by visual assessment of conventional immunohistochemistry. Leuk Lymphoma. 2017 Jul;58(7):1607-1616. doi: 10.1080/10428194.2016.1256481. Epub 2016 Nov 20.

  PMID: 27868471 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Hematologic Diseases; Lymphoma

Interventions

Brentuximab Vedotin; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Seattle Genetics, Inc.

medinfo@seagen.com

855-473-2436

Study Officials

• Corinna Palanca-Wessels, MD, PhD

  Seagen Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 23, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 28, 2016
• Results First Posted: October 13, 2016

Record last verified: 2015-06

Locations

CA (1); US (33)