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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00425555




Registration number
NCT00425555
Ethics application status
Date submitted
22/01/2007
Date registered
23/01/2007
Date last updated
18/11/2016

Titles & IDs
Public title
Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Scientific title
A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Secondary ID [1] 0 0
2006-000880-27
Secondary ID [2] 0 0
CLBH589B2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous T-Cell 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

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

Experimental: Previously treated with oral bexarotene -

Experimental: No prior oral bexarotene treatmemt -


Treatment: Drugs: Panobinostat


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

Outcomes
Primary outcome [1] 0 0
Response rate assessed by: visceral disease, lymph nodes, blood,samples and a modified Severity-Weighted Assessment Tool (mSWAT) score to assess skin disease
Timepoint [1] 0 0
Monthly
Secondary outcome [1] 0 0
Response rate assessed by the Physicians Global Assessment of Clinical Condition (PGA)
Timepoint [1] 0 0
Monthly
Secondary outcome [2] 0 0
Responses in index lesions assessed by lesion measurements with photographic supporting documentation
Timepoint [2] 0 0
Monthly
Secondary outcome [3] 0 0
Improvement in Cutaneous T-Cell Lymphoma (CTCL)-related symptoms and patient-reported outcomes
Timepoint [3] 0 0
Monthly
Secondary outcome [4] 0 0
Safety and tolerability assessed by adverse events, serious adverse events and/or dose de-escalation
Timepoint [4] 0 0
Every Visit
Secondary outcome [5] 0 0
Pharmacokinetic (PK) profile of LBH589
Timepoint [5] 0 0
1st month of treatment

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Written informed consent obtained prior to any screening procedures

2. Age = 18 years old

3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome.
Patients with SS who have bone marrow involvement are also eligible.

4. Patients must have received at least two prior treatment regimens at least one of
which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA,
photophoresis, chemotherapy such as methotrexate, and interferon. Topical steroids
alone are not considered as a treatment regimen.

5. Patients must have had disease progression on or following their most recent treatment
regimen or an inadequate response to their most recent treatment regimen.

6. Patients will be accrued to one of two groups: Patients previously treated with oral
bexarotene and patients who have not had prior oral bexarotene treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Prior treatment with an HDAC inhibitor.

2. Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note;
Patients with SS who have bone marrow involvement are eligible.

3. Impaired cardiac function

4. Concomitant use of drugs with a risk of causing torsades de pointes

5. Patients who have received chemotherapy or any investigational drug or undergone major
surgery < 4 weeks prior to starting study drug or who have not recovered from side
effects of such therapy

6. Less than 3 months since prior electron beam therapy

7. Female patients who are pregnant or breast feeding, or patients of reproductive
potential not using an effective method of birth control, and male patients whose
sexual partners are women of childbearing potential not using effective birth control
Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [2] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Belgium
State/province [17] 0 0
Yvoir
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Finland
State/province [20] 0 0
Helsinki
Country [21] 0 0
France
State/province [21] 0 0
Cedex 02
Country [22] 0 0
France
State/province [22] 0 0
Creteil
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt/M
Country [26] 0 0
Germany
State/province [26] 0 0
Minden
Country [27] 0 0
Germany
State/province [27] 0 0
Würzburg
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
State/province [29] 0 0
Szeged
Country [30] 0 0
Italy
State/province [30] 0 0
AN
Country [31] 0 0
Italy
State/province [31] 0 0
BO
Country [32] 0 0
Italy
State/province [32] 0 0
FI
Country [33] 0 0
Italy
State/province [33] 0 0
TO
Country [34] 0 0
Italy
State/province [34] 0 0
Napoli
Country [35] 0 0
Spain
State/province [35] 0 0
Catalunya
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Switzerland
State/province [37] 0 0
Zürich

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory
Cutaneous T-Cell Lymphoma.
Trial website
https://clinicaltrials.gov/show/NCT00425555
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
Other publications