RecruitingT-cell LymphomaCutaneous/Peripheral T-Cell LymphomaPeripheral T-cell Lymphoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

8 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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

Sponsor: SciTech Development, Inc.

You may qualify if…

✓ All patients must have histologically or cytologically confirmed diagnosis of the following specific types of T-cell lymphomas (TCL):
✓ 1. Cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF), Sézary Syndrome (SS), or primary cutaneous CD30+ anaplastic large cell lymphoma (cALCL).
✓ 2. 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).
✓ Refractory disease is defined as lack of objective response (i.e., partial or complete response) to most recent therapy.
✓ Relapsed disease is defined as recurrent disease after prior therapy that does not qualify as refractory disease.
✓ Other systemic treatments not specified may be allowed based on PI judgement in consultation with the Sponsor.

You may not qualify if…

✕ 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.
✕ Concomitant drug administration.
✕ Patients who require concurrent treatment with drugs that are strong CYP3A inducers are excluded from the trial. Patients who have been treated previously with strong CYP3A inducers may enroll in the trial and receive their first dose of ST-001 only after four weeks have elapsed since the last dose of the CYP3A inducer. Strong inducers of human CYP3A include barbiturates, bosentan, carbamazepine, efavirenz, enzalutamide, etravirine, systemic glucocorticoids, mitotane, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, troglitazone as well as the OTC herbal product St John's Wort (https://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm#table2-3; http://www.mayomedicallaboratories.com/it-mmfiles/Cytochrome\_P450\_3A4\_and\_3A5\_Known\_Drug\_Interaction\_Chart.pdf; http://oncologypro.esmo.org/content/download/66542/1203090/file/CYP3A-inhibitors-inducers-DDI.pdf)
✕ Patients who require concurrent treatment with drugs that are strong to moderate CYP3A inhibitors are excluded from the trial, and patients who have been treated previously with strong CYP3A inhibitors may enroll in the trial and receive their first dose of ST-001 only after four weeks have elapsed since the last dose of the CYP3A inhibitor. This group of inhibitors includes certain antivirals (boceprevir, danoprevir, paritaprevir; elvitegravir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir, tipranavir; ombitasvir, dasabuvir), macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin, troleandomycin) and ciprofloxacin, antifungals (e.g., clotrimazole, fluconazole, ketoconazole, itraconazole, nefazodone, posaconazole, voriconazole), aprepitant, cimetidine, cobicistat, conivaptan, crizotinib, cyclosporine, diltiazem, dronedarone, idelalisib, luvoxamine, imatinib, tofisopam, suboxone and verapamil as well as dietary grapefruit juice and grapefruit (https://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm#table2-3; http://www.mayomedicallaboratories.com/it-mmfiles/Cytochrome\_P450\_3A4\_and\_3A5\_Known\_Drug\_Interaction\_Chart.pdf; http://oncologypro.esmo.org/content/download/66542/1203090/file/CYP3A-inhibitors-inducers-DDI.pdf)
✕ If patients being treated with ST-001 require the use of drugs that are either strong inducers of CYP3A or strong to moderate inhibitors of CYP3A to treat a medical condition, all treatment with ST-001 should be discontinued immediately and no further treatment with ST-001 will be allowed.

Where it's recruiting

Scottsdale

Duarte · Los Angeles

Aurora

Chicago

Ann Arbor · Detroit

Pittsburgh

Houston

Source: ClinicalTrials.gov · NCT04234048 · last updated 2025-09-22