eligibility 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, oral corticosteroids, total skin electron bean therapy, 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. 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 8. Uncontrolled hypertension 9. Concomitant use of any anti-cancer therapy or radiation therapy. Low potency topical steroid use is permitted. Topical bexarotene use is prohibited during the trial 10. Concomitant use of CYP3A4/5 inhibitors. 11. Patients with unresolved diarrhea \> CTCAE grade 1 12. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589 13. Other concurrent severe and/or uncontrolled medical conditions 14. Patients who would need to receive valproic acid for any reason during the study or ≤ 5 days prior to starting study drug. Other protocol-defined inclusion/exclusion criteria may apply
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5).
intervention Names
Drug: Panobinostat
label
Previously treated with oral bexarotene
type
EXPERIMENTAL
description
Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5).
intervention Names
Drug: Panobinostat
label
No prior oral bexarotene treatment
type
EXPERIMENTAL

interventions

arm Group Labels
No prior oral bexarotene treatment
Previously treated with oral bexarotene
name
Panobinostat
other Names
LBH589
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 139
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)
time Frame
Baseline up to 6 Months of Follow up

secondary Outcomes

description
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.
measure
The Overall Response Rate Using mSWAT Skin Score
time Frame
Baseline up to Cycle 12, an average of 12 months
description
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.
measure
Time to Response for Responders
time Frame
Baseline up to Cycle 12, an average of 12 months
description
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.
measure
Duration of Response (DOS)
time Frame
Baseline up to Cycle 12, an average of 12 months
description
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
measure
Progression-free Survival (PFS)
time Frame
Baseline up to Cycle 12, an average of 12 months
description
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.
measure
Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12
time Frame
Baseline up to Cycle 12, an average of 12 months
description
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.
measure
Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12
time Frame
Baseline up to Cycle 12, an average of 12 months
description
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.
measure
Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12
time Frame
Baseline up to Cycle 12, an average of 12 months
description
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.
measure
Maximum Plasma Concentration (Cmax) of Panobinostat
time Frame
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
description
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.
measure
Time to Peak Concentration (Tmax) of Panobinostat
time Frame
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
description
AUC is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours. The area under the plasma concentration-time curve from time zero to 48 hours. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
measure
Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat
time Frame
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
description
Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h.
measure
Time of Clast (Tlast) of Panobinostat
time Frame
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
description
Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.
measure
Last Observed Plasma Concentration (Clast) of Panobinostat
time Frame
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8

Full study description

brief Summary: This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.

Source references

references

citation
Duvic M, Dummer R, Becker JC, Poulalhon N, Ortiz Romero P, Grazia Bernengo M, Lebbe C, Assaf C, Squier M, Williams D, Marshood M, Tai F, Prince HM. Panobinostat activity in both bexarotene-exposed and -naive patients with refractory cutaneous T-cell lymphoma: results of a phase II trial. Eur J Cancer. 2013 Jan;49(2):386-94. doi: 10.1016/j.ejca.2012.08.017. Epub 2012 Sep 13.
pmid
22981498
type
RESULT

Source notices and limitations

Discovery and provenance

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section_5.14">14</a>,<a href="#cit/section_5.24">24</a>,<a href="#cit/section_5.25">25</a>]</li></ul></div></li><li>Oral methotrexate (<a href="/clinicaltrials/NCT00425555">NCT00425555</a>).[<a href="#cit/section_5.26">26</a>]</li><li>Pegylated liposomal doxorubicin.[<a href="#cit/section_5.27">27</a>-<a href="#cit/section_5.29">
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>14</a>,<a href="#cit/section_5.24">24</a>,<a href="#cit/section_5.25">25</a>]</li></ul></div></li><li>Oral methotrexate (<a href="/clinicaltrials/NCT00425555">NCT00425555</a>).[<a href="#cit/section_5.26">26</a>]</li><li>Pegylated liposomal doxorubicin.[<a href="#cit/section_5.27">27</a>-<a href="#cit/section_5.29">29</a>]</li><
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unded by the order in which the agents were introduced.</p> <div class="pdq-content-list"><ol id="_655"><li>Oral methotrexate (<a href="/clinicaltrials/NCT00425555">NCT00425555</a>).[<a href="#cit/section_6.30">30</a>]</li><li>Fludarabine, cladribine, and pentostatin are active agents for mycosis fungoides and Sézary
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order in which the agents were introduced.</p> <div class="pdq-content-list"><ol id="_655"><li>Oral methotrexate (<a href="/clinicaltrials/NCT00425555">NCT00425555</a>).[<a href="#cit/section_6.30">30</a>]</li><li>Fludarabine, cladribine, and pentostatin are active agents for mycosis fungoides and Sézary syndrome.[<a
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Mycosis Fungoides and Other Cutaneous T-Cell Lymphomas Treatment (PDQ®)–Health Professional Version
source update dates
context
Updated: February 19, 2025
datetime
2025-02-19T12:00:00Z
display
February 19, 2025
source url
https://www.cancer.gov/types/lymphoma/hp/mycosis-fungoides-treatment-pdq

Preserved source evidence · Not medical advice