Clinical trial · Interventional
Efficacy, Safety and Tolerability Study of SHAPE in IA, IB or IIA Cutaneous T-cell Lymphoma
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
NCT02213861CI-TRIAL-00024364unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T-Cell Lymphoma (CTCL) | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHAPE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1.0% SHAPE Gelled Solution once daily
- interventionNames
- Drug: SHAPE
- type
- EXPERIMENTAL
- label
- 0.5% SHAPE Gelled Solution twice daily
- interventionNames
- Drug: SHAPE
- type
- EXPERIMENTAL
- label
- 1.0% SHAPE Gelled Solution twice daily
- interventionNames
- Drug: SHAPE
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: * 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
References
Publications (1)
- DERIVEDValipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3. PMID 32632956