Full Text View
Tabular View
No Study Results Posted
Related Studies
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.

First Received on December 15, 2009.   Last Updated on May 3, 2011   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Compare Disease Free Survival in Pts. with Hodgkin's Lymphoma after achieving a complete response following Autologous stem cell transplant who are treated with panobinostat vs placebo based on investigator's review of radiological images [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare Overall Survival (OS) for the two arms [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • To estimate and compare the rate of relapse (RoR) at 6, 12, and 24 months from randomization for the two arms [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • To characterize the safety and tolerability of panobinostat Exploratory [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • To assess the safety and tolerability of panobinostat [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • To explore the relationship of Pharmacokinetics-pharmacodynamics (PK-PD) (safety and efficacy) in patients with HL following AHSCT [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

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
Criteria

Inclusion Criteria:

  1. Patient age is greater than or equal to 18 years
  2. Patient has a history of histologically confirmed classical HL (i.e. Nodular sclerosing (NSHL), Mixed-cellularity (MCHL), Lymphocyte-rich (LRHL), Lymphocyte depleted (LDHL))
  3. 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.

  4. 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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034163

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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

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

Keywords provided by Novartis:
Phase III randomized
double blind
placebo controlled multi-center study
panobinostat
Hodgkin's lymphoma
at risk for relapse
autologous stem cell transplant

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012