A Study of Brentuximab Vedotin in Adults Age 60 and Above With Newly Diagnosed Hodgkin Lymphoma (HL)
This study is currently recruiting participants.
Verified May 2013 by Seattle Genetics, Inc.
Sponsor:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01716806
First received: October 16, 2012
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
This is a single-arm, open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin as front-line therapy in adults age 60 and above with HL.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin Disease |
Drug: brentuximab vedotin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Single-arm, Open-label Study of Single-agent Brentuximab Vedotin for Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above |
Resource links provided by NLM:
Further study details as provided by Seattle Genetics, Inc.:
Primary Outcome Measures:
- Objective response rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
- Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
- Complete remission rate (CR) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Participants will be followed for an average of 2 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: Participants will be followed for an average of 2 years ] [ Designated as safety issue: No ]
- B symptom resolution rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
- Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose, 30 minutes, and 1 month post last dose ] [ Designated as safety issue: No ]
- Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, 8, 12, 16: predose, and 1 month post last dose ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Brentuximab Vedotin
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
|
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: SGN-35
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma
- Ineligible for or have declined initial conventional chemotherapy
- Measurable disease of at least 1.5 cm as documented by radiographic technique
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716806
Contacts
| Contact: Terri Lowe | 866-333-7436 | clinicaltrials@seagen.com |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294-3300 | |
| Contact: Stephanie Biggers 205-975-2944 sbiggers@uab.edu | |
| Principal Investigator: Andres Forero-Torres, MD | |
| United States, Arizona | |
| Arizona Oncology Associates, PC - HOPE | Recruiting |
| Tucson, Arizona, United States, 85704 | |
| Contact: Lee Williams 281-863-6660 Lee.Williams@usoncology.com | |
| Principal Investigator: Donald Brooks, M.D. | |
| United States, California | |
| Providence St Joseph Medical Center | Recruiting |
| Burbank, California, United States, 91505 | |
| Contact: Donna Fernando 818-748-4770 donna.fernando@providence.org | |
| Principal Investigator: Peter Rosen, MD | |
| City of Hope | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Christine McCarthy 626-256-4673 ext 63811 cmccarthy@coh.org | |
| Principal Investigator: Robert Chen, M.D. | |
| United States, Georgia | |
| Georgia Cancer Specialists - Admin Annex | Recruiting |
| Atlanta, Georgia, United States, 30341 | |
| Contact: Christopher Moore 770-496-9427 Christopher.Moore@gacancer.com | |
| Principal Investigator: Mansoor Saleh, M.D. | |
| United States, Illinois | |
| Illinois Cancer Specialists | Recruiting |
| Niles, Illinois, United States, 60714 | |
| Contact: Lee Williams 281-863-6660 Lee.Williams@usoncology.com | |
| Principal Investigator: Leonard Klein, M.D. | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Contact: Christine DiSilvestre 301-571-2016 cdisilvestre@ccbdmd.com | |
| Principal Investigator: Ralph Boccia, M.D. | |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10022 | |
| Contact: Sean Clark-Garvey 212-326-5736 sc2359@columbia.edu | |
| Principal Investigator: Jennifer Amengual, M.D. | |
| United States, Oregon | |
| Willamette Valley Cancer and Research / USOR | Recruiting |
| Eugene, Oregon, United States, 97401 | |
| Contact: Lee Williams 281-863-6660 Lee.Williams@usoncology.com | |
| Principal Investigator: Jeff Sharman, M.D. | |
| Northwest Cancer Specialists, P.C. | Recruiting |
| Tualatin, Oregon, United States, 97062 | |
| Contact: Lee Williams 281-863-6660 Lee.Williams@usoncology.com | |
| Principal Investigator: Christopher A Yasenchak, M.D. | |
| United States, Virginia | |
| Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care | Recruiting |
| Christianburg, Virginia, United States, 24073 | |
| Contact: Lee Williams 281-863-6660 Lee.Williams@usoncology.com | |
| Principal Investigator: Jerome Goldschmidt, M.D. | |
| Virginia Commonwealth University Medical Center | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Connie Honeycutt 804-628-1885 choneyc@vcu.edu | |
| Principal Investigator: Beata Holkova, M.D. | |
| United States, Washington | |
| Wenatchee Valley Medical Center | Recruiting |
| Wenatchee, Washington, United States, 98821 | |
| Contact: Lee Williams 281-863-6660 Lee.Williams@usoncology.com | |
| Principal Investigator: Mitchell Garrison, M.D. | |
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
| Study Director: | Megan O'Meara, MD | Seattle Genetics, Inc. |
More Information
No publications provided
| Responsible Party: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01716806 History of Changes |
| Other Study ID Numbers: | SGN35-015 |
| Study First Received: | October 16, 2012 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seattle Genetics, Inc.:
|
Antibody-Drug Conjugate Antibodies, Monoclonal Hematologic Diseases Hodgkin Disease Antigens, CD30 |
Lymphoma monomethylauristatin E Drug Therapy Immunotherapy |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013