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

Hodgkin's Lymphoma Clinical Trial

— PATH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034163
• Other study ID #: CLBH589E2301
• Secondary ID: 2009-014846-26
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2009
• Last updated: May 7, 2013
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• Panobinostat

• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Parkville	Victoria
Belgium	Novartis Investigative Site	Leuven
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Canada	Novartis Investigative Site	Toronto	Ontario
France	Novartis Investigative Site	Caen	Cedex
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Lille Cedex
Germany	Novartis Investigative Site	Duisburg
Germany	Novartis Investigative Site	Essen-Werden
Germany	Novartis Investigative Site	Köln
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Ramat Gan
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Reggio Calabria	RC
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Rotterdam
New Zealand	Novartis Investigative Site	Christchurch
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Wroclaw
Russian Federation	Novartis Investigative Site	ChelyabinskChemo
Russian Federation	Novartis Investigative Site	Saint Petersburg
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Barcelona	Cataluña
United States	Georgia Health Sciences University Medical College of Georgia	Augusta	Georgia
United States	Dana-Farber Cancer Institute Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina Oncology	Charleston	South Carolina
United States	Northwestern University Oncology	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Indiana University	Indianapolis	Indiana
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of California at Los Angeles	Los Angeles	California
United States	Medical College of Wisconsin Oncology	Milwaukee	Wisconsin
United States	Mary Babb Randolph Cancer Center	Morgantown	West Virginia
United States	Vanderbilt University Medical Center Vanderbilt Clinic - Oncology	Nashville	Tennessee
United States	Mayo Clinic - Rochester Hematology/Oncology Dept.	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  France,  Germany,  Israel,  Italy,  Netherlands,  New Zealand,  Poland,  Russian Federation,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		60 months	Yes
Secondary	To compare Overall Survival (OS) for the two arms		60 months	No
Secondary	To estimate and compare the rate of relapse (RoR) at 6, 12, and 24 months from randomization for the two arms		60 months	No
Secondary	To characterize the safety and tolerability of panobinostat Exploratory		60 months	Yes
Secondary	To assess the safety and tolerability of panobinostat		60 months	Yes
Secondary	To explore the relationship of Pharmacokinetics-pharmacodynamics (PK-PD) (safety and efficacy) in patients with HL following AHSCT		60 months	Yes