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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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).

Official Title

A Randomized Phase 2 Study to Evaluate Three Treatment Regimens of SHAPE, a Histone Deacetylase Inhibitor, in Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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
Exclusion Criteria:
  1. - 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


Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology

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