Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
TetraLogic Pharmaceuticals
With
The Leukemia and Lymphoma Society
Therapeutics, Inc.
Veristat, Inc.
PPD Development, LP
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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%
Clareo Health | Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
