A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

NCT01716806 | Completed Phase 2 Results

• 1 other identifier: SGN35-015
• Study Type: interventional
• Target: 131
• Locations: 2 countries
• Sites: 54

Brief Summary

This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.

Conditions

Hodgkin Disease; Peripheral T Cell Lymphoma

Keywords

Antibody-Drug Conjugate; Antibodies, Monoclonal; Hematologic Diseases; Hodgkin Disease; Antigens, CD30; Lymphoma; monomethylauristatin E; Drug Therapy; CD30-expression; PTCL; Seattle Genetics

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)

  Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).

  Up to 81 months

• ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)

  Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).

  Up to 60 months

• ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)

  Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.

  Up to 31 months

Secondary Outcomes (12)

• Number of Participants With Adverse Events

  Up to 122 months

• Number of Participants With Laboratory Abnormalities

  Up to 30 months

• Complete Response Rate

  Up to 81 months

• Duration of Complete Response

  Up to 81 months

• Duration of Objective Response

  Up to 81 months

Study Arms (6)

Part A: Brentuximab Vedotin in HL Patients

EXPERIMENTAL

Drug: brentuximab vedotin

Part B: Brentuximab Vedotin + Dacarbazine in HL Patients

EXPERIMENTAL

Drug: brentuximab vedotin; Drug: dacarbazine

Part C: Brentuximab Vedotin + Bendamustine in HL Patients

EXPERIMENTAL

Drug: brentuximab vedotin; Drug: bendamustine

Part D: Brentuximab Vedotin + Nivolumab in HL Patients

EXPERIMENTAL

Drug: brentuximab vedotin; Drug: nivolumab

Part E: Brentuximab Vedotin in HL Patients

EXPERIMENTAL

Drug: brentuximab vedotin

Part F: Brentuximab Vedotin in PTCL Patients

EXPERIMENTAL

Drug: brentuximab vedotin

Interventions

brentuximab vedotin DRUG

1.8 mg/kg every 3 weeks by IV infusion

Also known as: Adcetris; SGN-35

Part A: Brentuximab Vedotin in HL Patients; Part B: Brentuximab Vedotin + Dacarbazine in HL Patients; Part C: Brentuximab Vedotin + Bendamustine in HL Patients; Part D: Brentuximab Vedotin + Nivolumab in HL Patients; Part E: Brentuximab Vedotin in HL Patients; Part F: Brentuximab Vedotin in PTCL Patients

bendamustine DRUG

70 mg/m\^2 by IV infusion on Days 1 and 2 of 3-week cycle

Part C: Brentuximab Vedotin + Bendamustine in HL Patients

dacarbazine DRUG

375 mg/m\^2 every 3 weeks by IV infusion

Part B: Brentuximab Vedotin + Dacarbazine in HL Patients

nivolumab DRUG

3 mg/kg every 3 weeks by IV infusion

Part D: Brentuximab Vedotin + Nivolumab in HL Patients

Eligibility Criteria

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

You may qualify if:

• Parts A, B, C, and D: 60 years of age or older
• Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
• Treatment-naive patients with CD30-expressing PTCL (Part F)
• Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
• Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
• A CIRS score of 10 or greater
• Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
• Measurable disease of at least 1.5 cm as documented by radiographic technique
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)

You may not qualify if:

• Symptomatic neurologic disease compromising IADLs or requiring medication
• History of progressive multifocal leukoencephalopathy
• Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
• Concurrent use of other investigational agents
• Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
• History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
• Part D only:
• Received any prior immune-oncology therapy
• History of known or suspected autoimmune disease
• Prior allogeneic stem cell transplant
• History of cerebral vascular event within 6 months of first dose of study drug
• Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
• Known history of pancreatitis
• Parts D, E, and F only:
• Known cerebral/meningeal disease related to the underlying malignancy

Sponsors & Collaborators

• Seagen Inc.: lead
• Bristol-Myers Squibb: collaborator

Study Sites (54)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

University of South Alabama - Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Alaska Urological Institute

Anchorage, Alaska, 99503, United States

Location

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, 85710, United States

Location

Arizona Cancer Center / University of Arizona

Tucson, Arizona, 85724-5024, United States

Location

Highlands Oncology Group

Springdale, Arkansas, J. Thaddeus Beck, United States

Location

Providence St Joseph Medical Center

Burbank, California, 91505, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Wilshire Oncology Medical Group Inc.

Pomona, California, 91767, United States

Location

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, 80012, United States

Location

Florida Cancer Affiliates

Trinity, Florida, 34655, United States

Location

IACT Health

Columbus, Georgia, 31904, United States

Location

Georgia Cancer Specialists / Northside Hospital Cancer Institute

Sandy Springs, Georgia, 30341, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Illinois Cancer Specialists / Advocate Lutheran General Hospital

Niles, Illinois, 60714, United States

Location

American Oncology Networks LLC

Bethesda, Maryland, 20817, United States

Location

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, 48201, United States

Location

Minnesota Oncology Hematology P.A.

Minneapolis, Minnesota, 55404, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Morristown Medical Center/ Carol G. Simon Cancer Center

Morristown, New Jersey, 07960, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12208, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

James P. Wilmot Cancer Center / University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

James Cancer Hospital / Ohio State University

Columbus, Ohio, 43210, United States

Location

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

Location

Northwest Cancer Specialists, P.C.

Tigard, Oregon, 97223, United States

Location

Prisma Health

Greenville, South Carolina, 29615, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

Texas Oncology - Bedford

Bedford, Texas, 76022, United States

Location

Texas Oncology - Presbyterian Cancer Center Dallas

Dallas, Texas, 75231, United States

Location

Texas Oncology - Denton South

Denton, Texas, Kurkul, United States

Location

Texas Oncology - Fort Worth 12th Avenue

Fort Worth, Texas, 76104, United States

Location

Houston Methodist Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030, United States

Location

Texas Oncology - Longview

Longview, Texas, 75601, United States

Location

Texas Oncology - McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology - Seton Williamson

Round Rock, Texas, 78665, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care

Salem, Virginia, 24153, United States

Location

Shenandoah Oncology P.C.

Winchester, Virginia, 22601, United States

Location

Benaroya Research Institute/Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98821, United States

Location

Carbone Cancer Center / University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

University of Alberta / Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Royal Victoria Hospital, McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (4)

• Friedberg JW, Bordoni R, Patel-Donnelly D, Larson T, Goldschmidt J, Boccia R, Cline VJM, Mamidipalli A, Liu J, Akyol A, Yasenchak CA. Brentuximab vedotin with dacarbazine or nivolumab as frontline cHL therapy for older patients ineligible for chemotherapy. Blood. 2024 Feb 29;143(9):786-795. doi: 10.1182/blood.2022019536.

  PMID: 37946283 DERIVED

• Friedberg JW, Forero-Torres A, Bordoni RE, Cline VJM, Patel Donnelly D, Flynn PJ, Olsen G, Chen R, Fong A, Wang Y, Yasenchak CA. Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged >/=60 years with HL. Blood. 2017 Dec 28;130(26):2829-2837. doi: 10.1182/blood-2017-06-787200. Epub 2017 Oct 16.

  PMID: 29038340 DERIVED

• Forero-Torres A, Holkova B, Goldschmidt J, Chen R, Olsen G, Boccia RV, Bordoni RE, Friedberg JW, Sharman JP, Palanca-Wessels MC, Wang Y, Yasenchak CA. Phase 2 study of frontline brentuximab vedotin monotherapy in Hodgkin lymphoma patients aged 60 years and older. Blood. 2015 Dec 24;126(26):2798-804. doi: 10.1182/blood-2015-06-644336. Epub 2015 Sep 16.

  PMID: 26377597 DERIVED

• Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. doi: 10.3109/10428194.2013.876496. Epub 2014 Feb 24.

  PMID: 24359243 DERIVED

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, T-Cell, Peripheral; Hematologic Diseases; Lymphoma

Interventions

Brentuximab Vedotin; Bendamustine Hydrochloride; Dacarbazine; Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Seagen Inc.

medinfo@seagen.com

(855) 473-2436

Study Officials

• Robert Sims, MD

  Seagen Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: October 16, 2012
• First Posted: October 30, 2012
• Study Start: October 31, 2012
• Primary Completion: April 7, 2023
• Study Completion: September 12, 2023
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-05

Locations

CA (5); US (49)