Health Trials

Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma

ConditionsT-cell LymphomaCutaneous/Peripheral T-Cell LymphomaPeripheral T-cell LymphomaPeripheral T-Cell Lymphoma, Not ClassifiedPrimary Cutaneous T-cell LymphomaCutaneous T-Cell Lymphoma, UnspecifiedCutaneous T-cell LymphomaFollicular T-Cell LymphomaAngioimmunoblastic T-cell LymphomaSézary's DiseaseMycosis Fungoides
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSciTech Development, Inc.

About this trial

This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).

Eligibility criteria

Qualifiers

Cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF), Sézary Syndrome (SS), or primary cutaneous CD30+ anaplastic large cell lymphoma (cALCL).

Nodal TCL: Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), or follicular T-cell lymphoma (FTCL) as defined in the 2016 revision of the WHO classification of lymphoid malignancies[98] (Appendix A).

For standard phase 1a and expanded cohort (1b): Patients must all have at least one measurable disease site using criteria provided in section 11.

Relapsed or refractory (R/R) disease, after at least 1 prior treatment regimen as per disease staging (including but not limited to oral bexarotene, interferon, any oral or IV HDAC inhibitor, any topical, oral or IV chemotherapy drugs, radiotherapy, retinoids, topical steroids, systemic steroids, phototherapy, immunomodulators, Biologics and others based on PI discretion. Refer to section 2.1 of the protocol for more details).

Disqualifiers

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Patients who are receiving any other investigational agents.

Patients with known or history of central nervous system (CNS) disease are excluded from this clinical trial because of their poor prognosis and because of concerns regarding toxicity attribution.

History of allergic reactions or sensitivity to retinoids or to any excipients of ST-001.

Trial design

Treatments tested in this trial

  • Fenretinide

Treatment groups

46 Participants
are divided into 1 treatment group

Sponsors and collaborators

SciTech Development, Inc.

Lead sponsor

Source ClinicalTrials.gov