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)

May 27, 2016 updated by: Novartis Pharmaceuticals

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)

The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
    • PR
      • Curitiba, PR, Brazil, 81520-060
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
      • Dijon, France, 21079
        • Novartis Investigative Site
      • Lille Cedex, France, 59 037
        • Novartis Investigative Site
    • Cedex
      • Caen, Cedex, France, 14033
        • Novartis Investigative Site
      • Duisburg, Germany, 47166
        • Novartis Investigative Site
      • Essen-Werden, Germany, 45239
        • Novartis Investigative Site
      • Koeln, Germany, 50937
        • Novartis Investigative Site
      • Haifa, Israel, 3525408
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5266202
        • Novartis Investigative Site
    • RC
      • Reggio Calabria, RC, Italy, 89124
        • Novartis Investigative Site
      • Amsterdam, Netherlands
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3075 EA
        • Novartis Investigative Site
      • Christchurch, New Zealand, 8011
        • Novartis Investigative Site
      • Krakow, Poland, 30-510
        • Novartis Investigative Site
      • Wroclaw, Poland, 50-367
        • Novartis Investigative Site
      • ChelyabinskChemo, Russian Federation, 620102
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 197022
        • Novartis Investigative Site
      • Singapore, Singapore, 119228
        • Novartis Investigative Site
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • University of California at Los Angeles
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Health Sciences University Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60611-3308
        • Northwestern University Oncology
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute Dana-Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester Hematology/Oncology Dept.
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Oncology
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center Vanderbilt Clinic - Oncology
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9162
        • Mary Babb Randolph Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Panobinostat (PAN)
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW),
Other Names:
  • LBH589
Placebo Comparator: Placebo
Participants received matching placebo to PAN TIW, QOW.
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 23 months
Safety monitoring was conducted throughout the study.
23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 17, 2009

Study Record Updates

Last Update Posted (Estimate)

July 7, 2016

Last Update Submitted That Met QC Criteria

May 27, 2016

Last Verified

May 1, 2016

More Information

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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