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This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy, tolerability, and safety of 2 initial dose levels of bexarotene capsules in participants with refractory CTCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bexarotene 150 milligrams (mg)/square meter (m^2)/day | Experimental | Participants will receive bexarotene 150 mg/m^2/day once daily for 24 weeks. |
|
| Bexarotene 300 mg/m^2/day | Experimental | Participants will receive bexarotene 300 mg/m^2/day once daily for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bexarotene | Drug | Soft gelatin capsules to be taken orally with at least 6 ounces of water or other fluid either with or immediately following the evening meal (a moderate or full meal) or a nutritionally defined liquid food. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity | Index lesion symptoms/grade include: erythema=0 (no evidence)-8 (very severe); scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence of change)-8 (very severe change); area of involvement=0 (0 centimeters [cm]^2)-18 (>300 cm^2). CA generated by sum of grades of signs/symptoms for each index lesion. Index lesion CA grade at baseline was divided into CA grade at each subsequent study visit to determine participant's response to treatment. Ratio of CA <1.0=improvement in disease; ratio >1.0=worsening of disease. Tumor response as determined by CA=percentage of participants achieving CR (CA ratio=0, no clinically abnormal lymph nodes, and absence of histologic signs of CTCL); CCR (CA ratio=0 and no clinically abnormal lymph nodes); and PR (CA ratio=≤0.5, <25% increase in number/aggregate area of abnormal lymph nodes/tumors, and no new abnormal lymph nodes in documented area of absence of disease). | Baseline up to Week 24 |
| Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical Condition | The PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear [≥90%-<100%] of disease since Baseline), 2 (marked improvement [≥75%-<90%] of disease since Baseline), 3 (moderate improvement [≥50%-<70%] of disease since Baseline). Stable Disease (SD)=PGA grade of 4 (slight improvement [<25%-<50%] of disease since Baseline) or 5 (no change in disease [+/-<25% change since Baseline]). Progressive Disease (PD)=PGA grade of 6 (worse disease [≥25%] than at baseline). If visceral disease or an abnormal lymph node was located in a documented area of absence of disease, then PD would be reported for the participant. | Baseline up to Week 24 |
| Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined Percent Body Surface Area (BSA) Involvement |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Tumor Response (CR, CCR, or PR) as Determined by Investigator's CA of Index Lesion Disease Severity | Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); area of involvement=0 (0 cm^2)-18 (>300 cm^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio <1.0=improvement and >1.0=worsening of disease. Tumor response=percentage of participants with CR (CA ratio=0, no clinically abnormal lymph nodes, absence of CTCL histologic signs); CCR (CA ratio=0; no clinically abnormal lymph nodes); PR (CA ratio=≤0.5, <25% increase in number/aggregate area of abnormal lymph nodes/tumors, no new abnormal lymph nodes in documented area of absence of disease). |
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Inclusion Criteria:
Exclusion Criteria
Cutaneous T-cell lymphoma involving the central nervous system.
Participants with known Human Immunodeficiency Virus (HIV) infection and active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (HBV/HCV or HIV testing is not required for the purpose of this study).
Participation in any other investigational drug study within 30 days of entry in this study.
Within 5 years after the onset of menopause.
Received systemic corticosteroids within 6 months of entry in the study.
Known hypersensitivity to bexarotene or other component of bexarotene capsules.
Pregnancy, intent to become pregnant, or breast-feeding.
Received gemfibrozil within 1 day of starting the study.
Prior therapy for the treatment of CTCL:
Psoralens and ultraviolet A light (PUVA) or ultraviolet B light (UVB) therapy within 3 weeks of study entry.
Electron beam radiation therapy (EBT) or photopheresis within 3 weeks of study entry.
Topical retinoids, nitrogen mustard, carmustine (BCNU), imiquimod, or other antipruritic medication within 2 weeks of study entry.
If antipruritic medication cannot be avoided, antihistamine or antipruritic agents must be administered using a stable dose regimen for at least 1 week prior to initiation of study drug treatment and throughout the study, unless it is determined that a discontinuation or reduction in dose is indicated. Prior to the enrollment of any participant who will be taking systemic or dermatologically-applied antihistamine or anti-pruritic agent, the investigator must contact Eisai to discuss the need for such agent. Mineral oil, baby oil, and simple moisturizing lotions may be used as emollients. Low- to mid- potency topical corticosteroids are allowed only for participants with erythroderma (Stage III/IV CTCL) using a stable dose regimen for at least 4 weeks prior to study entry. High potency topical corticosteroids and tar baths are NOT permitted.
NOTE: Prior to the enrollment of any participant who will be taking systemic or dermatologically-applied antihistamine or anti-pruritic agent, the Investigator must contact the Sponsor to discuss the need for such agent.
Anticancer therapy of any kind (for example, methotrexate, cyclophosphamide, vorinostat, romidepsin, and interferon) within 30 days of entry to the study. Participant must recover from all signs of toxicity prior to entry in the study.
Oral retinoid therapy for any indication within 3 months of study entry.
Systemic therapy with Vitamin A in doses of greater than 15,000 International Units (IU) (5,000 microgram [mcg]) per day (equivalent to approximately 3 times Recommended Daily Allowance [RDA]) within 30 days of entry in this study.
Systemic antibiotic therapy within 2 weeks of entry in the study. (Participants with infections requiring antibiotics or likely to require antibiotics should be appropriately treated with a course of antibiotics terminating at least two weeks prior to entry, or if indicated, a chronic suppressive or prophylactic dose of antibiotics stabilized at least 2 weeks prior to entry. Participants who require initiation of or changes in antibiotic therapy during the study will not be considered a violation of the study protocol).
History of pancreatitis or significant risk factors for developing pancreatitis (for example, prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity).
Unwillingness or inability to minimize exposure to sunlight and artificial ultraviolet light while receiving bexarotene capsules.
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| Name | Affiliation | Role |
|---|---|---|
| Mandeep Kaur, MD | Valeant Pharmaceutical NA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Florida Academic Dermatology Centers |
Participants were randomized in a 1:1 ratio to bexarotene 150 milligrams (mg)/square meter (m^2)/day or 300 mg/m^2/day.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bexarotene 150 mg/m^2/Day | Participants received bexarotene 150 mg/m^2/day once daily for 24 weeks. |
| FG001 | Bexarotene 300 mg/m^2/Day | Participants received bexarotene 300 mg/m^2/day once daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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To determine BSA involvement, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%. SD=none of the response classifications (that is, CR, CCR, PR, or PD) accurately describe the disease status. PD=an increase from Baseline in percent BSA of at least 25%. |
| Baseline up to Week 24 |
| Baseline up to Week 24 |
| Duration of Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition | Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear [≥90%-<100%] of disease since Baseline), 2 (marked improvement [≥75%-<90%] of disease since Baseline), 3 (moderate improvement [≥50%-<70%] of disease since Baseline). | Baseline up to Week 24 |
| Duration of Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement | Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. To determine BSA, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%. | Baseline up to Week 24 |
| Time to Tumor Response (CR, CCR, or PR) as Determined by CA of Index Lesion Disease Severity | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); and area of involvement=0 (0 cm^2)-18 (>300 cm^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio <1.0=improvement and >1.0=worsening of disease. Tumor response=percentage of participants with CR (CA ratio=0, no clinically abnormal lymph nodes, and absence of CTCL histologic signs); CCR (CA ratio=0 and no clinically abnormal lymph nodes); and PR (CA ratio=≤0.5, <25% increase in number/aggregate area of abnormal lymph nodes/tumors, and no new abnormal lymph nodes in documented area of absence of disease). | Baseline up to Week 24 |
| Time to Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear [≥90%-<100%] of disease since Baseline), 2 (marked improvement [≥75%-<90%] of disease since Baseline), 3 (moderate improvement [≥50%-<70%] of disease since Baseline). | Baseline up to Week 24 |
| Time to Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. To determine BSA, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%. | Baseline up to Week 24 |
| Time to Tumor Progression as Determined by CA of Index Lesion Disease Severity | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); and area of involvement=0 (0 cm^2)-18 (>300 cm^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio <1.0=improvement and >1.0=worsening of disease. Criteria for PD requires at least 1 component of the following: CA ratio=≥1.25, ≥25% increase in number/aggregate area of abnormal lymph nodes/tumors, or no new abnormal lymph nodes in documented area of absence of disease. | Baseline up to Week 24 |
| Time to Tumor Progression as Determined by PGA of Clinical Condition | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. PD=PGA grade of 6 (worse disease [≥25%] than at baseline). If visceral disease or an abnormal lymph node was located in a documented area of absence of disease, then PD would be reported for the participant. | Baseline up to Week 24 |
| Time to Tumor Progression as Determined by Percent BSA Involvement | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. To determine BSA involvement, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. PD=an increase from Baseline in percent BSA of at least 25%. | Baseline up to Week 24 |
| Miami |
| Florida |
| 33136 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Tulane | New Orleans | Louisiana | 70112 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota Medical School | Minneapolis | Minnesota | 55455 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Wake Forest University Health | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals-Case Medical Center | Cleveland | Ohio | 44106 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt | Nashville | Tennessee | 37206 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute At the University of Utah | Salt Lake City | Utah | 84112 | United States |
| Full Analysis Population | Received at Least 1 Dose of Study Drug |
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| Safety Population | Received at Least 1 Dose of Study Drug and had at least 1 safety assessment after treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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Participants who received at least 1 dose of study drug (Full Analysis Population).
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| ID | Title | Description |
|---|---|---|
| BG000 | Bexarotene 150 mg/m^2/Day | Participants received bexarotene 150 mg/m^2/day once daily for 24 weeks. |
| BG001 | Bexarotene 300 mg/m^2/Day | Participants received bexarotene 300 mg/m^2/day once daily for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity | Index lesion symptoms/grade include: erythema=0 (no evidence)-8 (very severe); scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence of change)-8 (very severe change); area of involvement=0 (0 centimeters [cm]^2)-18 (>300 cm^2). CA generated by sum of grades of signs/symptoms for each index lesion. Index lesion CA grade at baseline was divided into CA grade at each subsequent study visit to determine participant's response to treatment. Ratio of CA <1.0=improvement in disease; ratio >1.0=worsening of disease. Tumor response as determined by CA=percentage of participants achieving CR (CA ratio=0, no clinically abnormal lymph nodes, and absence of histologic signs of CTCL); CCR (CA ratio=0 and no clinically abnormal lymph nodes); and PR (CA ratio=≤0.5, <25% increase in number/aggregate area of abnormal lymph nodes/tumors, and no new abnormal lymph nodes in documented area of absence of disease). | Participants who received at least 1 dose of study drug (Full Analysis Population). | Posted | Count of Participants | Participants | Baseline up to Week 24 |
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| Primary | Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical Condition | The PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear [≥90%-<100%] of disease since Baseline), 2 (marked improvement [≥75%-<90%] of disease since Baseline), 3 (moderate improvement [≥50%-<70%] of disease since Baseline). Stable Disease (SD)=PGA grade of 4 (slight improvement [<25%-<50%] of disease since Baseline) or 5 (no change in disease [+/-<25% change since Baseline]). Progressive Disease (PD)=PGA grade of 6 (worse disease [≥25%] than at baseline). If visceral disease or an abnormal lymph node was located in a documented area of absence of disease, then PD would be reported for the participant. | Participants who received at least 1 dose of study drug (Full Analysis Population). | Posted | Count of Participants | Participants | Baseline up to Week 24 |
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| Primary | Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined Percent Body Surface Area (BSA) Involvement | To determine BSA involvement, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%. SD=none of the response classifications (that is, CR, CCR, PR, or PD) accurately describe the disease status. PD=an increase from Baseline in percent BSA of at least 25%. | Participants who received at least 1 dose of study drug (Full Analysis Population). | Posted | Count of Participants | Participants | Baseline up to Week 24 |
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| Secondary | Duration of Tumor Response (CR, CCR, or PR) as Determined by Investigator's CA of Index Lesion Disease Severity | Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); area of involvement=0 (0 cm^2)-18 (>300 cm^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio <1.0=improvement and >1.0=worsening of disease. Tumor response=percentage of participants with CR (CA ratio=0, no clinically abnormal lymph nodes, absence of CTCL histologic signs); CCR (CA ratio=0; no clinically abnormal lymph nodes); PR (CA ratio=≤0.5, <25% increase in number/aggregate area of abnormal lymph nodes/tumors, no new abnormal lymph nodes in documented area of absence of disease). | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for CA of index lesion disease severity. | Posted | Mean | Standard Deviation | days | Baseline up to Week 24 |
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| Secondary | Duration of Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition | Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear [≥90%-<100%] of disease since Baseline), 2 (marked improvement [≥75%-<90%] of disease since Baseline), 3 (moderate improvement [≥50%-<70%] of disease since Baseline). | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for PGA of clinical condition. | Posted | Mean | Standard Deviation | days | Baseline up to Week 24 |
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| Secondary | Duration of Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement | Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. To determine BSA, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%. | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for percent of BSA involvement. | Posted | Mean | Standard Deviation | days | Baseline up to Week 24 |
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| Secondary | Time to Tumor Response (CR, CCR, or PR) as Determined by CA of Index Lesion Disease Severity | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); and area of involvement=0 (0 cm^2)-18 (>300 cm^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio <1.0=improvement and >1.0=worsening of disease. Tumor response=percentage of participants with CR (CA ratio=0, no clinically abnormal lymph nodes, and absence of CTCL histologic signs); CCR (CA ratio=0 and no clinically abnormal lymph nodes); and PR (CA ratio=≤0.5, <25% increase in number/aggregate area of abnormal lymph nodes/tumors, and no new abnormal lymph nodes in documented area of absence of disease). | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for CA of index lesion disease severity. | Posted | Mean | Standard Deviation | days | Baseline up to Week 24 |
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| Secondary | Time to Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear [≥90%-<100%] of disease since Baseline), 2 (marked improvement [≥75%-<90%] of disease since Baseline), 3 (moderate improvement [≥50%-<70%] of disease since Baseline). | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for PGA of clinical condition. | Posted | Mean | Standard Deviation | days | Baseline up to Week 24 |
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| Secondary | Time to Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. To determine BSA, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%. | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for percent of BSA involvement. | Posted | Mean | Standard Deviation | days | Baseline up to Week 24 |
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| Secondary | Time to Tumor Progression as Determined by CA of Index Lesion Disease Severity | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); and area of involvement=0 (0 cm^2)-18 (>300 cm^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio <1.0=improvement and >1.0=worsening of disease. Criteria for PD requires at least 1 component of the following: CA ratio=≥1.25, ≥25% increase in number/aggregate area of abnormal lymph nodes/tumors, or no new abnormal lymph nodes in documented area of absence of disease. | Participants who received at least 1 dose of study drug (Full Analysis Population) and with evaluable PD data for CA of index lesion disease severity. | Posted | Mean | Standard Deviation | days | Baseline up to Week 24 |
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| Secondary | Time to Tumor Progression as Determined by PGA of Clinical Condition | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. PD=PGA grade of 6 (worse disease [≥25%] than at baseline). If visceral disease or an abnormal lymph node was located in a documented area of absence of disease, then PD would be reported for the participant. | Participants who received at least 1 dose of study drug (Full Analysis Population) and with progression. | Posted | Mean | Standard Deviation | days | Baseline up to Week 24 |
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| Secondary | Time to Tumor Progression as Determined by Percent BSA Involvement | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. To determine BSA involvement, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. PD=an increase from Baseline in percent BSA of at least 25%. | Participants who received at least 1 dose of study drug (Full Analysis Population) and with progression. | Posted | Mean | Standard Deviation | days | Baseline up to Week 24 |
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Baseline up to Week 28
Received at Least 1 Dose of Study Drug and had at least 1 safety assessment after treatment (Safety Population).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bexarotene 150 mg/m^2/Day | Participants received bexarotene 150 mg/m^2/day once daily for 24 weeks. | 11 | 30 | 21 | 30 | ||
| EG001 | Bexarotene 300 mg/m^2/Day | Participants received bexarotene 300 mg/m^2/day once daily for 24 weeks. | 13 | 29 | 21 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Thyroxine free decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pnemonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
Please contact Sponsor directly for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Americas, Inc. | aloncaric@bauschhealth.com |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077610 | Bexarotene |
| ID | Term |
|---|---|
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
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| PR |
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| Participants |
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Participants received bexarotene 300 mg/m^2/day once daily for 24 weeks. |
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| Participants |
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| Participants |
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Participants received bexarotene 300 mg/m^2/day once daily for 24 weeks.
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| Participants |
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