Clinical trial NCT00490776: Study of Oral LBH589 in Adult Participants With Refractory/Resistant Cutaneous T-Cell Lymphoma (CTCL)
Official title: A Phase II Study of Oral LBH589 in Adult Patients With Cutaneous T-Cell Lymphoma Who Are Intolerant to or Have Progressed on or After Prior HDAC Inhibitor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cutaneous T-Cell Lymphoma
Keywords: Cutaneous T-Cell Lymphoma
adults
Mycosis Fungoides
Sézary Syndrome
CTCL
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-06-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and efficacy of LBH589B in adult participants with refractory/resistant Cutaneous T-Cell Lymphoma and prior Histone Deacetylase (HDAC) inhibitor therapy.


Eligibility criteria: Inclusion criteria:

1. Written informed consent obtained prior to any screening procedures
2. Age greater than or equal to 18 years old
3. Participants with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome (SS). Participants with SS who have bone marrow involvement are also eligible. Participants with transformed CTCL are eligible
4. Participants must have been treated with an HDAC inhibitor given for the treatment of CTCL. Participants must have had disease progression on or following treatment with an HDAC inhibitor. Participants are also eligible if they had an inadequate response to an HDAC inhibitor defined as stable disease as the best response after at least 3 months of therapy. Participants previously treated with an HDAC inhibitor are also eligible if they experienced intolerance due to adverse events.
5. Baseline multiple-gated acquisition scan (MUGA) or echocardiogram must have demonstrated left ventricular ejection fraction (LVEF) ≥ the lower limit of the institutional normal
6. ECOG performance status ≤ 2

Exclusion criteria:

1. Participants with a history of visceral disease including central nervous system (CNS) involvement (i.e. stage IVB CTCL). Note, participants who have SS with bone marrow involvement are eligible
2. Impaired cardiac function
3. Concomitant use of drugs with a risk of causing torsades de pointes
4. Participants who have received chemotherapy or any investigational drug or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
5. Less than 3 months since prior electron beam therapy
6. Women who are pregnant or breast feeding, or women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study and 3 months after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall Response Rate (ORR) in Participants With Resistant Cutaneous T-Cell Lymphoma (CTCL) Treated With Oral Panobinostat by Using the Modified Severity-Weighted Assessment Tool (mSWAT)
timeFrame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
Secondary outcomes:
measure: Response Rate of Participants With Refractory CTCL Using the Physician's Global Assessment of Clinical Condition (PGA)
timeFrame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
measure: Response Rate in Participants With Refractory CTCL Using Modified Skin Score
timeFrame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
measure: Responses in Index Lesions in Participants With Refractory CTCL by Lesion Measurements With Photographic Supporting Documentation
timeFrame: From first dose of study drug up to disease progression or death (up to approximately 2 years)
measure: ORR of Participants With Resistant CTCL Treated With Oral Panobinostat by Using the Modified PGA to Assess Skin Disease and the Evaluation of Disease in the Viscera, Lymph Nodes and Blood (Circulating Sézary Syndrome Cells)
timeFrame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
measure: Duration of Response (DOR)
timeFrame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
measure: Time to Response (TTR)
timeFrame: From first dose of study drug up to study completion (approximately 2 years)
measure: Progression-Free Survival (PFS)
timeFrame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham/ The Kirklin Clinic
state: Alabama
city: Los Angeles
country: United States
facility: UCLA Medical Center School of Medicine/ Dpt of Hematology-Oncology
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center/Anschutz Cancer Pavillion
state: Colorado
city: Miami
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian Hospital/St. Luke's Medical Center
state: Illinois
city: Saint Louis
country: United States
facility: St. Louis University Cancer Cennter
state: Missouri
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: Bronx
country: United States
facility: Our Lady of Mercy Medical Center/Comprehensive Cancer Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
city: Winston-Salem
country: United States
facility: Wake University Health Sciences
state: North Carolina
city: Tulsa
country: United States
facility: University of Oklahoma-Tulsa
state: Oklahoma
city: Portland
country: United States
facility: Craig Okada
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
city: Germantown
country: United States
facility: The Jones Clinic
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center/University of Texas
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: