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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Panobinostat, 20 mg, hard gelatin capsules, orally, thrice weekly.
University of Alabama at Birmingham/ The Kirklin Clinic
Birmingham, Alabama, United States
UCLA Medical Center School of Medicine/ Dpt of Hematology-Oncology
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)
ORR was defined as the percentage of participants with best overall response (OR) of complete response (CR) or partial response (PR) based on mSWAT score, (OR = CR + PR). mSWAT score represents the product of the percentage total body surface area (%TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor: modified SWAT score = (patch %TBSA x 1) + (plaque %TBSA x 2) + (tumor or ulcer %TBSA x 4). The sum of these 3 numbers gave the modified SWAT score, on a 0 (no lesions) to 400 (lesions covering all areas) scale. CR based on mSWAT score was defined as the absence of skin disease. PR was defined as ≥ 50% decrease of the modified SWAT score compared to the Baseline score.
Time frame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
Response Rate of Participants With Refractory CTCL Using the Physician's Global Assessment of Clinical Condition (PGA)
Response rate was defined as the percentage of participants with CR or PR based on PGA scale. PGA is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the participant's disease as compared to Baseline. CR corresponds to Grade 0 (Completely clear) on PGA scale and was defined as no evidence of disease; 100% improvement. PR corresponds to Grade 2 (marked improvement) on PGA scale and was defined as significant improvement (≥75% - \<90%); some evidence of disease remains.
Time frame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
Response Rate in Participants With Refractory CTCL Using Modified Skin Score
Response rate was defined as the percentage of participants with CR or PR based on mSWAT skin score. mSWAT score represents the product of the %TBSA involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor: mSWAT score = (patch %TBSA x 1) + (plaque %TBSA x 2) + (tumor or ulcer %TBSA x 4). The sum of these 3 numbers gave the modified SWAT score, on a 0 (no lesions) to 400 (lesions covering all areas) scale. CR based on mSWAT score was defined as the absence of skin disease. PR was defined as ≥ 50% decrease of the modified SWAT score compared to the Baseline score.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Los Angeles, California, United States
University of Colorado Health Sciences Center/Anschutz Cancer Pavillion
Aurora, Colorado, United States
Florida Academic Dermatology Centers
Miami, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
Rush Presbyterian Hospital/St. Luke's Medical Center
Chicago, Illinois, United States
St. Louis University Cancer Cennter
St Louis, Missouri, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Clinical Cancer Center
New York, New York, United States
...and 8 more locations
Time frame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
Responses in Index Lesions in Participants With Refractory CTCL by Lesion Measurements With Photographic Supporting Documentation
Index lesions in each participant were selected as four to six of the prominent lesions amenable to bi-dimensional measurements. The longest diameter and its perpendicular measurement were used to determine the surface area and a weighted sum was determined as: Lesion 1 + lesion 2 + … + lesions 6 = Total sum of weighted score where Lesion 1: cm\^2 x \[1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)\]; Lesion 2: cm\^2 x \[1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)\]; Lesion 6: cm\^2 x \[1 (for patch); 2 (for plaque); 4 (for tumor or ulcer)\]. These lesions were photographed at Baseline and at the time of response determined by either mSWAT or PGA
Time frame: From first dose of study drug up to disease progression or death (up to approximately 2 years)
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)
ORR was defined as the percentage of participants with best OR of CR or PR based on PGA scale (OR = CR + PR). The PGA is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the participant's disease as compared to Baseline. CR corresponds to Grade 0 (completely clear) of PGA scale and was defined as no evidence of disease; 100% improvement. PR corresponds to Grade 2 (marked improvement) of PGA scale and was defined as significant improvement (≥75%-\<90%); some evidence of disease remains.
Time frame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
Duration of Response (DOR)
DOR was defined as the time from first documented evidence of CR or PR until the earliest date of documented progression or death due to any cause among participants who achieved a confirmed CR or PR. The DOR was calculated in two ways. The DOR among responders only included participants who responded to the drug. The overall DOR included non-responders as having a DOR of zero days.
Time frame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)
Time to Response (TTR)
TTR was defined as the time from the start of treatment until the first documented evidence of CR or PR among participants who achieved a confirmed CR or PR.
Time frame: From first dose of study drug up to study completion (approximately 2 years)
Progression-Free Survival (PFS)
PFS was defined as the time from the start of treatment until the earliest date of disease progression or death due to any cause, if sooner.
Time frame: From first dose of study drug up to disease progression or death, (up to approximately 2 years)