Trial · NCT00425555

Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma

NCT00425555, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-08-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma. Trials, record NCT00425555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00425555

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
NCT number: NCT00425555
Status: Completed
Phases: Phase 2
Enrollment: 139 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Cutaneous T-Cell Lymphoma
Interventions: Panobinostat
First posted: 2007-01-23
Last updated: 2021-08-20
Other registries' IDs: eudract:2006-000880-27
Results first posted: 2021-08-16

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)	Baseline up to 6 Months of Follow up	Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007). Responses in the skin based on SWAT are defined as: * Complete Response (CR): no evidence of skin disease * Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline * Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score * Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline.
Secondary	The Overall Response Rate Using mSWAT Skin Score	Baseline up to Cycle 12, an average of 12 months	Estimate of the response rate of participants with resistant cutaneous T-cell lymphoma (CTCL) treated with Panobinostat using the mSWAT skin scores and 95% CI will be analyzed.
Secondary	Time to Response for Responders	Baseline up to Cycle 12, an average of 12 months	Time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
Secondary	Duration of Response (DOS)	Baseline up to Cycle 12, an average of 12 months	Duration of response and time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
Secondary	Progression-free Survival (PFS)	Baseline up to Cycle 12, an average of 12 months	PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment
Secondary	Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12	Baseline up to Cycle 12, an average of 12 months	Skin index measurement (Skindex-29) was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess emotions scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Secondary	Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12	Baseline up to Cycle 12, an average of 12 months	Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess functioning scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Secondary	Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12	Baseline up to Cycle 12, an average of 12 months	Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess physical symptoms scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Secondary	Maximum Plasma Concentration (Cmax) of Panobinostat	Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8	Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.
Secondary	Time to Peak Concentration (Tmax) of Panobinostat	Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8	Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's PK profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)	Baseline up to 6 Months of Follow up	The analysis was performed in Full Analysis Set (FAS) population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.	percentage	NUMBER
SECONDARY	The Overall Response Rate Using mSWAT Skin Score	Baseline up to Cycle 12, an average of 12 months	The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Response for Responders	Baseline up to Cycle 12, an average of 12 months	The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.	Days	MEDIAN
SECONDARY	Duration of Response (DOS)	Baseline up to Cycle 12, an average of 12 months	The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.	Days	MEDIAN
SECONDARY	Progression-free Survival (PFS)	Baseline up to Cycle 12, an average of 12 months	The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.	months	MEDIAN
SECONDARY	Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12	Baseline up to Cycle 12, an average of 12 months	The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.	score on a scale	MEAN
SECONDARY	Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12	Baseline up to Cycle 12, an average of 12 months	The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.	score on a scale	MEAN
SECONDARY	Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12	Baseline up to Cycle 12, an average of 12 months	The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study.	score on a scale	MEAN
SECONDARY	Maximum Plasma Concentration (Cmax) of Panobinostat	Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8	The analysis was performed in PK population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.	ng/mL	MEAN
SECONDARY	Time to Peak Concentration (Tmax) of Panobinostat	Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8	The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.	h (hours)	MEDIAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group104

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)	Bexarotene Exposed		16.7	95% Confidence Interval 8.1 to 25.0	percentage
Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)	Bexarotene Naive		20.3	95% Confidence Interval 10.8 to 32.3	percentage
Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)	All Participants		18.5	95% Confidence Interval 11.4 to 24.6	percentage
The Overall Response Rate Using mSWAT Skin Score	Bexarotene Exposed	mSWAT skin response (CR/PR)flare considered as disease progression ( f.i.p ) - Number of responders	12		Participants
The Overall Response Rate Using mSWAT Skin Score	Bexarotene Naive	mSWAT skin response (CR/PR)flare considered as disease progression ( f.i.p ) - Number of responders	14		Participants
The Overall Response Rate Using mSWAT Skin Score	All Participants	mSWAT skin response (CR/PR)flare considered as disease progression ( f.i.p ) - Number of responders	26		Participants
The Overall Response Rate Using mSWAT Skin Score	Bexarotene Exposed	Physician's Global Assessment- Responder (CR/PR)	15		Participants
The Overall Response Rate Using mSWAT Skin Score	Bexarotene Naive	Physician's Global Assessment- Responder (CR/PR)	18		Participants
The Overall Response Rate Using mSWAT Skin Score	All Participants	Physician's Global Assessment- Responder (CR/PR)	33		Participants
Time to Response for Responders	Bexarotene Exposed		69.5	95% Confidence Interval 29.0 to 141.0	Days

1 to 10 of 104Source ClinicalTrials.gov

See all 104 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Bexarotene Exposed	79
Overall Study	STARTED	Bexarotene Naive	60
Overall Study	COMPLETED	Bexarotene Exposed	0
Overall Study	COMPLETED	Bexarotene Naive	0
Overall Study	NOT COMPLETED	Bexarotene Exposed	79
Overall Study	NOT COMPLETED	Bexarotene Naive	60

Source ClinicalTrials.gov

Adverse events342

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Bexarotene Exposed	17	79
other	Anaemia	Blood and lymphatic system disorders	Bexarotene Naive	6	60
other	Leukopenia	Blood and lymphatic system disorders	Bexarotene Exposed	9	79
other	Leukopenia	Blood and lymphatic system disorders	Bexarotene Naive	4	60
other	Neutropenia	Blood and lymphatic system disorders	Bexarotene Exposed	14	79
other	Neutropenia	Blood and lymphatic system disorders	Bexarotene Naive	10	60
other	Thrombocytopenia	Blood and lymphatic system disorders	Bexarotene Exposed	40	79
other	Thrombocytopenia	Blood and lymphatic system disorders	Bexarotene Naive	23	60
other	Vertigo	Ear and labyrinth disorders	Bexarotene Exposed	4	79
other	Vertigo	Ear and labyrinth disorders	Bexarotene Naive	0	60

1 to 10 of 342Source ClinicalTrials.gov

See all 342 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bexarotene Exposed	3	79
Total, all-cause mortality	Bexarotene Naive	3	60
Total, other adverse events	Bexarotene Exposed	77	79
Total, other adverse events	Bexarotene Naive	59	60
Total, serious adverse events	Bexarotene Exposed	33	79
Total, serious adverse events	Bexarotene Naive	23	60

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22981498	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Bexarotene Exposed vs Bexarotene Naive: deaths from any cause	Trial comparisons
Bexarotene Exposed vs Bexarotene Naive: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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