Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma

Status unconfirmed · Phase 2

Conditions studied: Cutaneous T-Cell Lymphoma (CTCL)

In brief

The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma (CTCL).

Key facts

Study ID

NCT02213861

Run by

TetraLogic Pharmaceuticals

People needed

60

Starts

2014-11-01

Expected to finish

2016-10-01

Last updated by the study team

2016-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological confirmation of CTCL; a documented verifiable biopsy report is required
• Documented clinical stage IA, IB or IIA CTCL
• Skin lesion involvement of at least 2% of BSA accessible for topical application of study drug
• ECOG performance status of 0-2

You may not qualify if…

• CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL
• Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and designated as Stage IA-IIA disease)
• Co-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curatively
• Any prior history of hematologic malignancy (other than CTCL) within past 5 years
• CTCL disease that is known to be refractory to systemic histone deacetylase inhibitors
• Prior or concurrent central nervous system (CNS) metastases
• History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary or hematologic 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 of clinical significance

Where it is running

• Stanford Cancer Center — Stanford, California, United States
• Northwestern Medical Group — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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