A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

NCT00866047 | Completed Phase 2 Results DMC

• 2 other identifiers: SG035-00042008-006035-12
• Study Type: interventional
• Target: 58
• Locations: 5 countries
• Sites: 22

Brief Summary

This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.

Conditions

Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin

Keywords

Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; monomethyl auristatin E; Drug Therapy; Immunotherapy; Hematologic Diseases; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate by Independent Review Group

  Percentage of participants 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 12 months

Secondary Outcomes (11)

• Complete Remission Rate by Independent Review Group

  up to 12 months

• Duration of Objective Response by Kaplan-Meier Analysis

  up to approximately 3 years

• Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis

  up to approximately 3 years

• Progression-free Survival by Kaplan-Meier Analysis

  up to approximately 3 years

• Overall Survival

  up to approximately 7 years

Other Outcomes (1)

• B Symptom Resolution

  up to 12 months

Study Arms (1)

Brentuximab vedotin

EXPERIMENTAL

Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion

Drug: brentuximab vedotin

Interventions

brentuximab vedotin DRUG

1.8 mg/kg every 3 weeks by IV infusion

Also known as: SGN-35, ADCETRIS

Brentuximab vedotin

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
• Documented anaplastic lymphoma kinase (ALK) status.
• Histologically-confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
• Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
• Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
• At US sites, patients greater than or equal to 12 years of age may be enrolled. At non-US sites, patients must be greater than or equal to 18 years of age.

You may not qualify if:

• Previous treatment with brentuximab vedotin.
• Previously received an allogeneic transplant.
• Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
• Known cerebral/meningeal disease.

Sponsors & Collaborators

• Seagen Inc.: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (22)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, 48201, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Baylor Sammons Cancer Center / Texas Oncology

Dallas, Texas, 75246, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030-4003, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

B.C Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Hospital Saint Louis

Paris, 75475, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Christie Hospital NHS

Manchester, M20 4BX, United Kingdom

Location

Related Publications (2)

• Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21.

  PMID: 22614995 RESULT

• Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. doi: 10.1182/blood-2017-05-780049. Epub 2017 Oct 3.

  PMID: 28974506 DERIVED

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin; Hematologic Diseases; Lymphoma

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; 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

Results Point of Contact

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

medinfo@seagen.com

855-473-2436

Study Officials

• Dana Kennedy, PharmD

  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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: June 1, 2016
• Last Updated: March 22, 2017
• Results First Posted: October 26, 2011

Record last verified: 2016-12

Locations

US (15); GB (1); BE (1); FR (3); CA (2)