- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034163
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL) (PATH)
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 (ASCT)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Victoria
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Parkville, Victoria, Australia, 3050
- Novartis Investigative Site
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Leuven, Belgium, 3000
- Novartis Investigative Site
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PR
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Curitiba, PR, Brazil, 81520-060
- Novartis Investigative Site
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RJ
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Rio de Janeiro, RJ, Brazil, 20230-130
- Novartis Investigative Site
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Novartis Investigative Site
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Dijon, France, 21079
- Novartis Investigative Site
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Lille Cedex, France, 59 037
- Novartis Investigative Site
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Cedex
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Caen, Cedex, France, 14033
- Novartis Investigative Site
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Duisburg, Germany, 47166
- Novartis Investigative Site
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Essen-Werden, Germany, 45239
- Novartis Investigative Site
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Koeln, Germany, 50937
- Novartis Investigative Site
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Haifa, Israel, 3525408
- Novartis Investigative Site
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Ramat Gan, Israel, 5266202
- Novartis Investigative Site
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RC
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Reggio Calabria, RC, Italy, 89124
- Novartis Investigative Site
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Amsterdam, Netherlands
- Novartis Investigative Site
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Rotterdam, Netherlands, 3075 EA
- Novartis Investigative Site
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Christchurch, New Zealand, 8011
- Novartis Investigative Site
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Krakow, Poland, 30-510
- Novartis Investigative Site
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Wroclaw, Poland, 50-367
- Novartis Investigative Site
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ChelyabinskChemo, Russian Federation, 620102
- Novartis Investigative Site
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Saint Petersburg, Russian Federation, 197022
- Novartis Investigative Site
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Singapore, Singapore, 119228
- Novartis Investigative Site
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California
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
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Los Angeles, California, United States, 90095
- University of California at Los Angeles
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Georgia
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Augusta, Georgia, United States, 30912
- Georgia Health Sciences University Medical College of Georgia
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Illinois
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Chicago, Illinois, United States, 60611-3308
- Northwestern University Oncology
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute Dana-Farber Cancer Institute
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic - Rochester Hematology/Oncology Dept.
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina Oncology
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center Vanderbilt Clinic - Oncology
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West Virginia
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Morgantown, West Virginia, United States, 26506-9162
- Mary Babb Randolph Cancer Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin Oncology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient age is greater than or equal to 18 years
- Patient has a history of histologically confirmed classical HL (i.e. Nodular sclerosing (NSHL), Mixed-cellularity (MCHL), Lymphocyte-rich (LRHL), Lymphocyte depleted (LDHL))
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:
- Primary refractory disease (including relapse in ≤ 3 months of completion of 1st line treatment)
- First relapse >3 but <12 months from last dose of 1st line treatment
- Multiple relapses (prior to transplant)
- Stage III/IV disease (at relapse, prior to transplant)
- Hemoglobin <10.5 gm/dL (at relapse, prior to transplant)
Exclusion Criteria:
Patient has been treated with allogeneic transplant 2. Patient has received any anti-lymphoma therapy after AHSCT including but not limited to:
- chemotherapy prior to start of study
- biologic immunotherapy including monoclonal antibodies or experimental therapy prior to start of study
- radiation therapy 3. Patient has not recovered from reversible toxicity due to any prior therapies (e.g. returned to baseline or Grade ≤1) except for hematological laboratory parameters Note: Patient does not meet this criteria if the toxicity is stable and irreversible, and there is no evidence that panobinostat causes a similar toxicity 4. Patient has received prior treatment with DAC inhibitors including panobinostat
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Panobinostat (PAN)
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW),
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Other Names:
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Placebo Comparator: Placebo
Participants received matching placebo to PAN TIW, QOW.
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Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Adverse Events
Time Frame: 23 months
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Safety monitoring was conducted throughout the study.
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23 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLBH589E2301
- 2009-014846-26
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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