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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Novartis Investigative Site
  • Belgium
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 81520-060
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
  • France
      • Dijon, France, 21079
        • Novartis Investigative Site
      • Lille Cedex, France, 59 037
        • Novartis Investigative Site
    • Cedex
      • Caen, Cedex, France, 14033
        • Novartis Investigative Site
  • Germany
      • Duisburg, Germany, 47166
        • Novartis Investigative Site
      • Essen-Werden, Germany, 45239
        • Novartis Investigative Site
      • Koeln, Germany, 50937
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 3525408
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5266202
        • Novartis Investigative Site
  • Italy
    • RC
      • Reggio Calabria, RC, Italy, 89124
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3075 EA
        • Novartis Investigative Site
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Novartis Investigative Site
  • Poland
      • Krakow, Poland, 30-510
        • Novartis Investigative Site
      • Wroclaw, Poland, 50-367
        • Novartis Investigative Site
  • Russian Federation
      • ChelyabinskChemo, Russian Federation, 620102
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 197022
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119228
        • Novartis Investigative Site
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Panobinostat (PAN)
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW),
Drug: Panobinostat
Other Names:
  • LBH589
Placebo Comparator: Placebo
Participants received matching placebo to PAN TIW, QOW.
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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