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A Study of Brentuximab Vedotin in Adults Age 60 and Above With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01716806
Recruitment Status : Recruiting
First Posted : October 30, 2012
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This trial will study brentuximab vedotin to find out whether it is an effective treatment in patients 60 years or older for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). The study will look at brentuximab vedotin alone and combined with other drugs.

Condition or disease Intervention/treatment Phase
Hodgkin Disease Peripheral T Cell Lymphoma Drug: brentuximab vedotin Drug: bendamustine Drug: dacarbazine Drug: nivolumab Phase 2

Detailed Description:
This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy in patients who are age 60 years or more. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Adults Age 60 and Above
Actual Study Start Date : October 2012
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2024


Arm Intervention/treatment
Experimental: Part A: Brentuximab Vedotin in HL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Experimental: Part B: Brentuximab Vedotin + Dacarbazine in HL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Drug: dacarbazine
375 mg/m2 every 3 weeks by IV infusion

Experimental: Part C: Brentuximab Vedotin + Bendamustine in HL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Drug: bendamustine
70 mg/m2 by IV infusion on Days 1 and 2 of 3-week cycle

Experimental: Part D: Brentuximab Vedotin + Nivolumab in HL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Drug: nivolumab
3 mg/kg every 3 weeks by IV infusion

Experimental: Part E: Brentuximab Vedotin in HL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Experimental: Part F: Brentuximab Vedotin in PTCL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: Through 1 month following last dose; up to approximately 16 months ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months ]
  2. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months ]
  3. Complete remission (CR) rate [ Time Frame: Through 1 month following last dose; up to approximately 16 months ]
  4. Duration of complete response [ Time Frame: Up to approximately 10 years ]
  5. Duration of objective response [ Time Frame: Up to approximately 10 years ]
  6. Progression-free survival [ Time Frame: Up to approximately 10 years ]
  7. Disease control rate [ Time Frame: Up to approximately 10 years ]
  8. B symptom resolution rate [ Time Frame: Through 1 month following last dose; up to approximately 16 months ]
  9. Blood concentrations of brentuximab vedotin [ Time Frame: Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes ]
  10. Incidence of brentuximab vedotin antitherapeutic antibodies (ATA) [ Time Frame: Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose ]
  11. Blood concentrations of nivolumab [ Time Frame: Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes ]
  12. Incidence of nivolumab antitherapeutic antibodies (ATA) [ Time Frame: Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose ]
  13. Overall survival (Parts E and F only) [ Time Frame: Up to approximately 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
  • Treatment-naïve patients with CD30-expressing PTCL (Part F)
  • 75+ years of age or 60+ years and have depressed ejection fraction or moderately severe renal dysfunction (Parts E and F only)
  • Ineligible for initial conventional combination chemotherapy for HL (Parts A, B, C, D, E) or CD30-expressing PTCL (Part F), or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
  • 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

Exclusion Criteria:

  • Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716806


Contacts
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Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

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Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Amitkumar Mehta    205-996-8400    amitkumarmehta@uabmc.edu   
Contact: Melonie Hupp    205-975-2944    mjwest@uabmc.edu   
Principal Investigator: Amitkumar Mehta, MD         
United States, Alaska
Alaska Urological Institute Recruiting
Anchorage, Alaska, United States, 99503
Contact: Talia Wyckoff    907-276-1455    twyckoff@akmed.com   
Contact: Amanda Chriswell    907-276-1455    achriswell@akmed.com   
Principal Investigator: Musaberk Goksel, MD         
United States, Arizona
Arizona Oncology Associates, PC - HOPE Recruiting
Tucson, Arizona, United States, 85710
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Donald Brooks, MD         
United States, California
Providence St Joseph Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Anneliese Cadena    818-748-4797    Anneliese.cadena@providence.org   
Principal Investigator: Raul Mena, MD         
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Maria Castillo    626-256-4673    macastillo@coh.org   
Principal Investigator: Matthew Mei, MD         
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: John Burke, MD         
United States, Georgia
Georgia Cancer Specialists / Northside Hospital Cancer Institute Recruiting
Sandy Springs, Georgia, United States, 30341
Contact: Duane Stallings    770-496-9400    duane.stallings@gacancer.com   
Principal Investigator: Rodolfo Bordoni, MD         
United States, Illinois
Illinois Cancer Specialists / Advocate Lutheran General Hospital Recruiting
Niles, Illinois, United States, 60714
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Leonard Klein, MD         
United States, Maryland
Center for Cancer and Blood Disorders/RCCA Recruiting
Bethesda, Maryland, United States, 20817
Contact: Jennifer Cipriano    301-571-2016    jcipriano@regionalcancercare.org   
Principal Investigator: Ralph Boccia, MD         
United States, Minnesota
Minnesota Oncology Hematology P.A. Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Timothy Larson, MD         
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Ralph Hauke, MD         
United States, New York
New York Oncology Hematology, P.C. Recruiting
Albany, New York, United States, 12208
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Lawrence Garbo, MD         
James P. Wilmot Cancer Center / University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Krista French    585-275-4911    Krista_French@URMC.Rochester.edu   
Principal Investigator: Jonathan Friedberg, MD         
United States, Ohio
Oncology Hematology Care Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: James Essell, MD         
United States, Oregon
Willamette Valley Cancer Institute and Research Center Recruiting
Eugene, Oregon, United States, 97401
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Christopher Yasenchak, MD         
Northwest Cancer Specialists, P.C. Recruiting
Tigard, Oregon, United States, 97223
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Spencer Shao, MD         
United States, South Carolina
Prisma Health-Upstate Recruiting
Greenville, South Carolina, United States, 29615
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Jeffrey Giguere         
United States, Texas
Texas Oncology - Bedford Recruiting
Bedford, Texas, United States, 76022
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Henrik Illum, MD         
Texas Oncology - Presbyterian Cancer Center Dallas Recruiting
Dallas, Texas, United States, 75231
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Contact: Kelly Johnson    (214)346-3508    Kelly.Johnson@usoncology.com   
Principal Investigator: Kristi McIntyre, MD         
Texas Oncology - Denton South Recruiting
Denton, Texas, United States, 76210
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Charles Kurkul, MD         
Texas Oncology - Fort Worth 12th Avenue Recruiting
Fort Worth, Texas, United States, 76104
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Robert L. Ruxer, MD         
Texas Oncology - Longview Recruiting
Longview, Texas, United States, 75601
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Matei Socoteanu, MD         
Texas Oncology - Seton Williamson Recruiting
Round Rock, Texas, United States, 78665
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Vivian Cline-Burkhardt, MD         
United States, Virginia
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care Recruiting
Blacksburg, Virginia, United States, 24060
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Jerome Goldschmidt, MD         
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Dipti Patel-Donnelly, MD         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Kristin Lantis    804-828-2177    kllantis@vcu.edu   
Principal Investigator: Victor Yazbeck, MD         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: John Pagel    206-215-1426    jpagel@fhcrc.org   
Principal Investigator: John Pagel         
Sponsors and Collaborators
Seattle Genetics, Inc.
Bristol-Myers Squibb
Investigators
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Study Director: Linda Ho, MD Seattle Genetics, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01716806     History of Changes
Other Study ID Numbers: SGN35-015
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 27, 2019
Keywords provided by Seattle Genetics, Inc.:
Antibody-Drug Conjugate
Antibodies, Monoclonal
Hematologic Diseases
Hodgkin Disease
Antigens, CD30
Lymphoma
monomethylauristatin E
Drug Therapy
CD30-expression
PTCL
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Nivolumab
Bendamustine Hydrochloride
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action