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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT01034163 |
Purpose
The purpose of this phase III study is to evaluate the efficacy of orally-administered panobinostat in reducing the risk of relapse in patients with classical Hodgkin's Lymphoma who achieved a complete response following high-dose chemotherapy (HDT) with Autologous stem cell transplant(AHSCT).
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin's Lymphoma |
Drug: Panobinostat Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma Who Are at Risk for Relapse After High Dose Chemotherapy and Autologous Stem Cell Transplant |
| Estimated Enrollment: | 367 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Panobinostat |
Drug: Panobinostat
Other Name: LBH589
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has achieved a complete response by CT/MRI scan within 9 weeks (± 1 week) from the day of their first autologous peripheral blood/ bone marrow stem cell transfusion (AHSCT) following HDT. Complete response is defined as:
Normalization of all nodes and lesions compared to pre-transplant scan performed prior to salvage therapy for relapse. Any residual abnormal masses on the post transplant CT/MRI must be metabolically inactive on a PET scan.
Patient has at least one of the following factors that places them at risk for relapse:
Exclusion Criteria:
Patient has been treated with allogeneic transplant 2. Patient has received any anti-lymphoma therapy after AHSCT including but not limited to:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| United States, California | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| Cedars-Sinai Medical Center | |
| Los angeles, California, United States, 90048 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Indiana | |
| Indiana Bone and Marrow Transplantation, LLC | |
| Beach Grove, Indiana, United States, 46107 | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5240 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical center | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusettes General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| Mayo Clinic Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Capitol Cmprehensive Cancer Care Clinic | |
| Jefferson City, Missouri, United States, 65109 | |
| United States, New York | |
| SUNY Upstate Medical Center | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Rhode Island | |
| Pharma Resource | |
| East Providence, Rhode Island, United States, 02915 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Novartis Investigative Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, West Virginia | |
| Mary Babb Randolph Cancer Center | |
| Morgantown, West Virginia, United States, 26506 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01034163 History of Changes |
| Other Study ID Numbers: | CLBH589E2301 |
| Study First Received: | December 15, 2009 |
| Last Updated: | May 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Phase III randomized double blind placebo controlled multi-center study panobinostat |
Hodgkin's lymphoma at risk for relapse autologous stem cell transplant |
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |