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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Hodgkin's Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

60 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589E2301

NCT ID:

NCT01034163

Start Date:

June 2010

Completion Date:

May 2012

Related Keywords:

  • Hodgkin's Lymphoma
  • 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

Name

Location

Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Duke University Medical CenterDurham, North Carolina  27710
Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506
Indiana UniversityIndianapolis, Indiana  46202
University of California at Los AngelesLos Angeles, California  90095
Georgia Health Sciences University Medical College of GeorgiaAugusta, Georgia  30912
Northwestern University OncologyChicago, Illinois  60611-3308
Dana-Farber Cancer Institute Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Mayo Clinic - Rochester Hematology/Oncology Dept.Rochester, Minnesota  55905
Medical University of South Carolina OncologyCharleston, South Carolina  29425
Vanderbilt University Medical Center Vanderbilt Clinic - OncologyNashville, Tennessee  37232
Medical College of Wisconsin OncologyMilwaukee, Wisconsin  53226