Lymphoma, T-Cell, Cutaneous
Conditions
Keywords
CTCL, Cutaneous T-Cell Lymphoma
Brief summary
The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.
Interventions
DRUGplacebo for SHAPE (SHP-141)
topical gelled solution
DRUGSHAPE (SHP-141) 0.1% BID
topical gelled solution
DRUGSHAPE (SHP-141) 0.5% BID
topical gelled solution
DRUGSHAPE (SHP-141) 1.0% BID
topical gelled solution
Sponsors
The Leukemia and Lymphoma Society
Therapeutics, Inc.
Veristat, Inc.
PPD Development, LP
TetraLogic Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histopathologically confirmed CTCL; a documented verifiable biopsy report is required. * Documented clinical Stage IA, IB, or IIA CTCL. * Skin lesion involvement of at least 3% of BSA accessible for topical application of study drug and biopsy. * ECOG performance status of 0-2.
Exclusion criteria
* CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL. * Severe pruritus requiring systemic or topical treatment. * Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and has been designated as Stage IA-IIA disease). * Coexistent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix (CIN 3), papillary or follicular thyroid cancer that has been treated curatively, or prostate cancer that has been treated curatively). * Any prior history of a hematologic malignancy (other than CTCL). * History of or current major renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genito-urinary or hematological disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator. * Evidence of active Hepatitis B or C or HIV. * Circulating atypical cells \>5%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity) | Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42 | Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response criteria measure the change in CAILS score from baseline to follow-up as follows: Complete Response (CR): 100% decrease in CAILS score; Partial Response (PR): 50% - 99% decrease in CAILS score; Stable Disease (SD): \< 25% increase to \< 50% decrease in CAILS score; Progressive Disease (PD) ≥ 25% increase in CAILS score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo for SHAPE (SHP-141) placebo for SHAPE (SHP-141): topical gel | 3 |
| SHAPE (SHP-141) 0.1% BID SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily | 5 |
| SHAPE (SHP-141) 0.5% BID SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily | 5 |
| SHAPE (SHP-141) 1.0% BID SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily | 5 |
| Total | 18 |
Baseline characteristics
| Characteristic | Placebo for SHAPE (SHP-141) | SHAPE (SHP-141) 0.1% BID | SHAPE (SHP-141) 0.5% BID | SHAPE (SHP-141) 1.0% BID | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 4 Participants | 3 Participants | 12 Participants |
| Region of Enrollment United States | 3 participants | 5 participants | 5 participants | 5 participants | 18 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 3 | 5 / 5 | 4 / 5 | 4 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)
Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response criteria measure the change in CAILS score from baseline to follow-up as follows: Complete Response (CR): 100% decrease in CAILS score; Partial Response (PR): 50% - 99% decrease in CAILS score; Stable Disease (SD): \< 25% increase to \< 50% decrease in CAILS score; Progressive Disease (PD) ≥ 25% increase in CAILS score.
Time frame: Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SHAPE (SHP-141) | Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity) | 27 percentage of participants |
| Placebo for SHAPE (SHP-141) | Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity) | 0 percentage of participants |