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

NCT01034163 | Completed Phase 3 Results DMC

• 2 other identifiers: CLBH589E23012009-014846-26
• Study Type: interventional
• Target: 41
• Locations: 14 countries
• Sites: 35

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Safety monitoring was conducted throughout the study.

  23 months

Study Arms (2)

Panobinostat (PAN)

EXPERIMENTAL

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

Drug: Panobinostat

Placebo

PLACEBO COMPARATOR

Participants received matching placebo to PAN TIW, QOW.

Drug: Placebo

Interventions

Panobinostat DRUG

Also known as: LBH589

Panobinostat (PAN)

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (35)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

Georgia Health Sciences University Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Northwestern University Oncology

Chicago, Illinois, 60611-3308, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic - Rochester Hematology/Oncology Dept.

Rochester, Minnesota, 55905, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Medical University of South Carolina Oncology

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center Vanderbilt Clinic - Oncology

Nashville, Tennessee, 37232, United States

Location

Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506-9162, United States

Location

Medical College of Wisconsin Oncology

Milwaukee, Wisconsin, 53226, United States

Location

Novartis Investigative Site

Parkville, Victoria, 3050, Australia

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Curitiba, Paraná, 81520-060, Brazil

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Caen, Cedex, 14033, France

Location

Novartis Investigative Site

Lille, France, 59 037, France

Location

Novartis Investigative Site

Dijon, 21079, France

Location

Novartis Investigative Site

Cologne, 50937, Germany

Location

Novartis Investigative Site

Duisburg, 47166, Germany

Location

Novartis Investigative Site

Essen-Werden, 45239, Germany

Location

Novartis Investigative Site

Haifa, 3525408, Israel

Location

Novartis Investigative Site

Ramat Gan, 5266202, Israel

Location

Novartis Investigative Site

Reggio Calabria, RC, 89124, Italy

Location

Novartis Investigative Site

Amsterdam, Netherlands

Location

Novartis Investigative Site

Rotterdam, 3075 EA, Netherlands

Location

Novartis Investigative Site

Christchurch, 8011, New Zealand

Location

Novartis Investigative Site

Krakow, 30-510, Poland

Location

Novartis Investigative Site

Wroclaw, 50-367, Poland

Location

Novartis Investigative Site

ChelyabinskChemo, 620102, Russia

Location

Novartis Investigative Site

Saint Petersburg, 197022, Russia

Location

Novartis Investigative Site

Singapore, Singapore, 119228, Singapore

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 17, 2009
• Study Start: June 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 7, 2016
• Results First Posted: July 7, 2016

Record last verified: 2016-05

Locations

DE (3); NZ (1); US (13); IT (1); PL (2); SG (1); IL (2); BE (1); FR (3); BR (2); AU (1); RU (2); CA (1); NL (2)