Study of Oral LBH589 in Adult Participants With Refractory/Resistant Cutaneous T-Cell Lymphoma (CTCL)
- Registration Number
- NCT00490776
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Panobinostat 20 mg Panobinostat Participants received panobinostat, 20 milligrams (mg), capsules, orally, thrice weekly on alternate Days 1, 3, and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression, and/or physician's discretion to discontinue the treatment.
- Primary Outcome Measures
Name Time Method 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) From first dose of study drug up to disease progression or death, (up to approximately 2 years) 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.
- Secondary Outcome Measures
Name Time Method Response Rate of Participants With Refractory CTCL Using the Physician's Global Assessment of Clinical Condition (PGA) From first dose of study drug up to disease progression or death, (up to approximately 2 years) 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.
Response Rate in Participants With Refractory CTCL Using Modified Skin Score From first dose of study drug up to disease progression or death, (up to approximately 2 years) 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.
Responses in Index Lesions in Participants With Refractory CTCL by Lesion Measurements With Photographic Supporting Documentation From first dose of study drug up to disease progression or death (up to approximately 2 years) 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
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) From first dose of study drug up to disease progression or death, (up to approximately 2 years) 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 to Response (TTR) From first dose of study drug up to study completion (approximately 2 years) 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.
Progression-Free Survival (PFS) From first dose of study drug up to disease progression or death, (up to approximately 2 years) 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.
Duration of Response (DOR) From first dose of study drug up to disease progression or death, (up to approximately 2 years) 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.
Trial Locations
- Locations (18)
Rush Presbyterian Hospital/St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
UCLA Medical Center School of Medicine/ Dpt of Hematology-Oncology
🇺🇸Los Angeles, California, United States
Florida Academic Dermatology Centers
🇺🇸Miami, Florida, United States
University of Alabama at Birmingham/ The Kirklin Clinic
🇺🇸Birmingham, Alabama, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Colorado Health Sciences Center/Anschutz Cancer Pavillion
🇺🇸Aurora, Colorado, United States
St. Louis University Cancer Cennter
🇺🇸Saint Louis, Missouri, United States
Our Lady of Mercy Medical Center/Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
NYU Clinical Cancer Center
🇺🇸New York, New York, United States
Wake University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Pittsburg Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Craig Okada
🇺🇸Portland, Oregon, United States
MD Anderson Cancer Center/University of Texas
🇺🇸Houston, Texas, United States
The Jones Clinic
🇺🇸Germantown, Tennessee, United States
University of Oklahoma-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States