A Study of Brentuximab Vedotin in Adults Age 60 and Above With Newly Diagnosed Hodgkin Lymphoma (HL)
Overview[ - collapse ][ - ]
| Purpose | This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin as a single-agent (Part A) and in combination with dacarbazine (Part B) in front-line therapy of HL in adults age 60 and above. |
|---|---|
| Condition | Hodgkin Disease |
| Intervention | Drug: brentuximab vedotin Drug: dacarbazine |
| Phase | Phase 2 |
| Sponsor | Seattle Genetics, Inc. |
| Responsible Party | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier | NCT01716806 |
| First Received | October 16, 2012 |
| Last Updated | March 27, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 16, 2012 |
|---|---|
| Last Updated Date | March 27, 2014 |
| Start Date | October 2012 |
| Estimated Primary Completion Date | December 2017 |
| Current Primary Outcome Measures | Objective response rate [Time Frame: Through 1 month following last dose] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of Brentuximab Vedotin in Adults Age 60 and Above With Newly Diagnosed Hodgkin Lymphoma (HL) |
|---|---|
| Official Title | A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above |
| Brief Summary | This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin as a single-agent (Part A) and in combination with dacarbazine (Part B) in front-line therapy of HL in adults age 60 and above. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Hodgkin Disease |
| Intervention | Drug: brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion Other Names: Adcetris; SGN-35Drug: dacarbazine 375 mg/m2 every 3 weeks by IV infusion |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | December 2017 |
| Estimated Primary Completion Date | October 2015 |
| Eligibility Criteria | Inclusion Criteria: - Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma - Ineligible for or have declined initial conventional combination 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 |
| Gender | Both |
| Ages | 60 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01716806 |
|---|---|
| Other Study ID Numbers | SGN35-015 |
| Has Data Monitoring Committee | No |
| Information Provided By | Seattle Genetics, Inc. |
| Study Sponsor | Seattle Genetics, Inc. |
| Collaborators | Not Provided |
| Investigators | Study Director: Neil Josephson, MD Seattle Genetics, Inc. |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| University of Alabama at Birmingham | Birmingham, Alabama, United States, 35294-3300 Contact: Stephanie Biggers | 205-975-2944 | sbiggers@uab.eduPrincipal Investigator: Andres Forero-Torres, MD Recruiting |
|---|---|
| Arizona Oncology Associates, PC - HOPE | Tucson, Arizona, United States, 85704 Contact: Marrae McWilliams | 520-877-9096 | marrae.mcwilliams@usoncology.comPrincipal Investigator: Donald Brooks, M.D. Recruiting |
| Providence St Joseph Medical Center | Burbank, California, United States, 91505 Contact: Donna Fernando | 818-748-4770 | donna.fernando@providence.orgPrincipal Investigator: Gregg Olsen, M.D. Recruiting |
| City of Hope | Duarte, California, United States, 91010 Contact: Christine McCarthy | 626-256-467363811 | cmccarthy@coh.orgPrincipal Investigator: Robert Chen, M.D. Recruiting |
| Wilshire Oncology Medical Group Inc. | Pomona, California, United States, 91767 Contact: Sarah Ortiz | 909-596-5333 | Sarah.Ortiz@usoncology.comPrincipal Investigator: Swapnil P. Rajurkar, MDM.D. Recruiting |
| Rocky Mountain Cancer Centers - Aurora | Aurora, Colorado, United States, 80012 Contact: Sara Vigen | 719-296-6024 | sara.vigen@usoncology.comPrincipal Investigator: John M. Burke, M.D. Recruiting |
| Florida Cancer Affiliates | New Port Richey, Florida, United States, 34655 Contact: Kelly Bretz | 727-569-4135 | Kelly.Bretz@USOncology.comPrincipal Investigator: Uday Dandamudi, M.D. Recruiting |
| Georgia Cancer Specialists - Admin Annex | Sandy Springs, Georgia, United States, 30341 Contact: Christopher Moore | 770-496-9427 | Christopher.Moore@gacancer.comPrincipal Investigator: Mansoor Saleh, M.D. Recruiting |
| Illinois Cancer Specialists | Niles, Illinois, United States, 60714 Contact: Pian Moy | 847-827-9060 | Pian.Moy@usoncology.comPrincipal Investigator: Leonard Klein, M.D. Recruiting |
| Center for Cancer and Blood Disorders | Bethesda, Maryland, United States, 20817 Contact: Christine DiSilvestre | 301-571-2016 | cdisilvestre@ccbdmd.comPrincipal Investigator: Ralph Boccia, M.D. Recruiting |
| Nebraska Cancer Specialists | Omaha, Nebraska, United States, 68114 Contact: Faye Park | 402-691-6972 | fpark@nebraskacancer.comPrincipal Investigator: Ralph J. Hauke -NCS, M.D. Recruiting |
| New York Oncology Hematology, P.C. | Albany, New York, United States, 12206 Contact: Kathy DiSisto | 518-786-3152312 | Kathy.Disisto@USONCOLOGY.COMPrincipal Investigator: Lawrence Garbo, M.D. Recruiting |
| Columbia University Medical Center | New York, New York, United States, 10022 Contact: Celeste Rojas | 212-326-5736 | CR2393@cumc.columbia.eduPrincipal Investigator: Jennifer Amengual, M.D. Recruiting |
| University of Rochester Medical Center | Rochester, New York, United States, 14642 Contact: Donald Burns | 585-273-3903 | Don_Burns@URMC.Rochester.eduPrincipal Investigator: Jonathan Friedberg, MD Recruiting |
| Willamette Valley Cancer and Research / USOR | Eugene, Oregon, United States, 97401 Contact: Betty Goracke Olguin | 541-736-3388 | betty.gorackeolguin@usoncology.comPrincipal Investigator: Jeff Sharman, M.D. Recruiting |
| Texas Oncology - Seton Williamson | Round Rock, Texas, United States, 78665 Contact: Marlena Griffin | 512-421-4142 | marlena.griffin@usoncology.comPrincipal Investigator: Vivian Cline-Burkhardt, M.D. Recruiting |
| Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care | Blacksburg, Virginia, United States, 24060 Contact: Melissa Jansky | 281-863-6658 | Melissa.Jansky@Mckesson.comPrincipal Investigator: Jerome Goldschmidt, M.D. Recruiting |
| Virginia Commonwealth University Medical Center | Richmond, Virginia, United States, 23298 Contact: Jaime Scott | 804-628-1909 | jscott@vcu.eduPrincipal Investigator: Beata Holkova, M.D. Recruiting |
| Shenandoah Oncology P.C | Winchester, Virginia, United States, 22601 Contact: Claudia Phillips | 540-662-1108 | claudia.phillips@usoncology.comPrincipal Investigator: William A. Houck III, M.D. Recruiting |
| Northwest Cancer Specialists, P.C. | Vancouver, Washington, United States, 98684 Contact: Tamyra Batsch | 503-885-5411 | tamyra.batsch@usoncology.comPrincipal Investigator: Kathryn Kolibaba, M.D. Recruiting |
| Wenatchee Valley Medical Center | Wenatchee, Washington, United States, 98821 Contact: LaDonna Muscatell | 509-663-87115014 | lmuscatell@wvmedical.comPrincipal Investigator: Mitchell Garrison, M.D. Recruiting |