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| Sponsor: | City of Hope Medical Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT01393717 |
Purpose
This phase II trial studies how well giving brentuximab vedotin before autologous stem cell transplant works in treating patients with Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Adult Hodgkin Lymphoma |
Drug: brentuximab vedotin Other: laboratory biomarker analysis Genetic: protein expression analysis |
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 II Study of Brentuximab Vedotin as Salvage Therapy for Hodgkin Lymphoma Prior to Autologous Hematopoietic Stem Cell Transplantation |
| Estimated Enrollment: | 37 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (monoclonal antibody therapy)
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
|
Drug: brentuximab vedotin
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Genetic: protein expression analysis
Correlative studies
|
PRIMARY OBJECTIVES:
I. The primary objective of this study is to determine the activity of salvage brentuximab vedotin in Hodgkin lymphoma prior to autologous hematopoietic stem cell transplantation, as measured by overall response rate (ORR).
SECONDARY OBJECTIVES:
I. To describe the safety, toxicity, and tolerability of brentuximab vedotin as a salvage regimen.
II. To summarize the stem cell mobilization results of patients receiving brentuximab vedotin as salvage therapy (e.g., total cluster of differentiation (CD)34+ cell yield, number of apheresis days, proportion of patients who achieve >= 3 x 10^6 CD34+ cells/kg).
III. To evaluate potential changes in Hodgkin lymphoma biological markers of patients treated with brentuximab vedotin.
OUTLINE:
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses.
After completion of study treatment, patients are followed up at 21 days.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| City of Hope Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Robert W. Chen 800-826-4673 rchen@coh.org | |
| Principal Investigator: Robert W. Chen | |
| Principal Investigator: | Robert Chen | City of Hope Medical Center |
More Information
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT01393717 History of Changes |
| Other Study ID Numbers: | 11051, NCI-2011-01135 |
| Study First Received: | July 8, 2011 |
| Last Updated: | December 7, 2011 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Antibodies Antibodies, Monoclonal Immunoconjugates Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |