A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL)

NCT ID: NCT01034163

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-05-31

Brief Summary

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.

Conditions

Hodgkin's Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Panobinostat (PAN)

Participants received 45 mg orally 3 times a week (TIW), every other week (QOW),

Group Type: EXPERIMENTAL

Panobinostat

Intervention Type: DRUG

Placebo

Participants received matching placebo to PAN TIW, QOW.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Panobinostat

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

LBH589

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California at Los Angeles

Los Angeles, California, United States

Georgia Health Sciences University Medical College of Georgia

Augusta, Georgia, United States

Northwestern University Oncology

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic - Rochester Hematology/Oncology Dept.

Rochester, Minnesota, United States

Duke University Medical Center

Durham, North Carolina, United States

Medical University of South Carolina Oncology

Charleston, South Carolina, United States

Vanderbilt University Medical Center Vanderbilt Clinic - Oncology

Nashville, Tennessee, United States

Mary Babb Randolph Cancer Center

Morgantown, West Virginia, United States

Medical College of Wisconsin Oncology

Milwaukee, Wisconsin, United States

Novartis Investigative Site

Parkville, Victoria, Australia

Novartis Investigative Site

Leuven, , Belgium

Novartis Investigative Site

Curitiba, Paraná, Brazil

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Caen, Cedex, France

Novartis Investigative Site

Lille, France, France

Novartis Investigative Site

Dijon, , France

Novartis Investigative Site

Cologne, , Germany

Novartis Investigative Site

Duisburg, , Germany

Novartis Investigative Site

Essen-Werden, , Germany

Novartis Investigative Site

Haifa, , Israel

Novartis Investigative Site

Ramat Gan, , Israel

Novartis Investigative Site

Reggio Calabria, RC, Italy

Novartis Investigative Site

Amsterdam, , Netherlands

Novartis Investigative Site

Rotterdam, , Netherlands

Novartis Investigative Site

Christchurch, , New Zealand

Novartis Investigative Site

Krakow, , Poland

Novartis Investigative Site

Wroclaw, , Poland

Novartis Investigative Site

ChelyabinskChemo, , Russia

Novartis Investigative Site

Saint Petersburg, , Russia

Novartis Investigative Site

Singapore, Singapore, Singapore

Countries

United States; Australia; Belgium; Brazil; Canada; France; Germany; Israel; Italy; Netherlands; New Zealand; Poland; Russia; Singapore

Other Identifiers

2009-014846-26

Identifier Type: -

Identifier Source: secondary_id

CLBH589E2301

Identifier Type: -

Identifier Source: org_study_id