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

Purpose

The purpose of this phase III study is to evaluate the efficacy of orally-administered panobinostat in reducing the risk of relapse in patients with classical Hodgkin's Lymphoma who achieved a complete response following high-dose chemotherapy (HDT) with Autologous stem cell transplant(AHSCT).

Condition	Intervention	Phase
Hodgkin's Lymphoma	Drug: Panobinostat Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease Lymphoma

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare Overall Survival (OS) for the two arms [ Time Frame: 60 months ] [ Designated as safety issue: No ]
To estimate and compare the rate of relapse (RoR) at 6, 12, and 24 months from randomization for the two arms [ Time Frame: 60 months ] [ Designated as safety issue: No ]
To characterize the safety and tolerability of panobinostat Exploratory [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of panobinostat [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
To explore the relationship of Pharmacokinetics-pharmacodynamics (PK-PD) (safety and efficacy) in patients with HL following AHSCT [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

Enrollment:	41
Study Start Date:	June 2010
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Panobinostat	Drug: Panobinostat Other Name: LBH589
Placebo Comparator: Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034163

Show 37 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01034163 History of Changes
Other Study ID Numbers:	CLBH589E2301, 2009-014846-26
Study First Received:	December 15, 2009
Last Updated:	May 7, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Phase III randomized
double blind
placebo controlled multi-center study
panobinostat

Hodgkin's lymphoma
at risk for relapse
autologous stem cell transplant

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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