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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01034163




Registration number
NCT01034163
Ethics application status
Date submitted
15/12/2009
Date registered
17/12/2009
Date last updated
7/07/2016

Titles & IDs
Public title
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL)
Scientific 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 (ASCT)
Secondary ID [1] 0 0
2009-014846-26
Secondary ID [2] 0 0
CLBH589E2301
Universal Trial Number (UTN)
Trial acronym
PATH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Panobinostat
Treatment: Drugs - Placebo

Experimental: Panobinostat (PAN) - Participants received 45 mg orally 3 times a week (TIW), every other week (QOW),

Placebo Comparator: Placebo - Participants received matching placebo to PAN TIW, QOW.


Treatment: Drugs: Panobinostat


Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
23 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
West Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Brazil
State/province [13] 0 0
PR
Country [14] 0 0
Brazil
State/province [14] 0 0
RJ
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
France
State/province [16] 0 0
Cedex
Country [17] 0 0
France
State/province [17] 0 0
Dijon
Country [18] 0 0
France
State/province [18] 0 0
Lille Cedex
Country [19] 0 0
Germany
State/province [19] 0 0
Duisburg
Country [20] 0 0
Germany
State/province [20] 0 0
Essen-Werden
Country [21] 0 0
Germany
State/province [21] 0 0
Koeln
Country [22] 0 0
Israel
State/province [22] 0 0
Haifa
Country [23] 0 0
Israel
State/province [23] 0 0
Ramat Gan
Country [24] 0 0
Italy
State/province [24] 0 0
RC
Country [25] 0 0
Netherlands
State/province [25] 0 0
Amsterdam
Country [26] 0 0
Netherlands
State/province [26] 0 0
Rotterdam
Country [27] 0 0
New Zealand
State/province [27] 0 0
Christchurch
Country [28] 0 0
Poland
State/province [28] 0 0
Krakow
Country [29] 0 0
Poland
State/province [29] 0 0
Wroclaw
Country [30] 0 0
Russian Federation
State/province [30] 0 0
ChelyabinskChemo
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Saint Petersburg
Country [32] 0 0
Singapore
State/province [32] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01034163
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01034163