Actively Recruiting
Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma
Led by SciTech Development, Inc. · Updated on 2025-09-22
46
Participants Needed
10
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).
CONDITIONS
Official Title
Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of specific T-cell lymphomas: cutaneous T-cell lymphoma (mycosis fungoides, Sézary Syndrome, primary cutaneous CD30+ anaplastic large cell lymphoma) or nodal T-cell lymphoma subtypes (peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma) as defined by WHO 2016
- Measurable disease site for standard phase 1a and expanded cohort
- Relapsed or refractory disease after at least one prior treatment regimen
- For primary cutaneous lymphomas, stage IB, II, III, or IV per TNMB system; for nodal lymphomas, stages II-IV per Ann Arbor staging
- Minimum 4 weeks since last systemic or radiation therapy (6 weeks for nitrosourea-containing regimens) with recovery from toxicity
- Age 18 years or older, any gender; women of childbearing potential must have negative pregnancy test and use effective contraception
- ECOG performance status 0-1 (Karnofsky ≥60%)
- Life expectancy greater than 6 months
- Normal organ and marrow function as defined by specified blood counts and chemistry
- Triglyceride blood level (fasting) less than 300 mg/dL at enrollment
- Informed consent obtained
You will not qualify if you...
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry or unresolved adverse events from earlier treatments
- Receiving other investigational agents
- Known or history of central nervous system disease
- Allergic reactions or sensitivity to retinoids or ST-001 excipients
- Concurrent use of strong CYP3A inducers or inhibitors without proper washout
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, prolonged QTc, or psychiatric/social conditions limiting compliance
- Pregnant or breastfeeding women
- HIV-positive patients on combination antiretroviral therapy
- Active hepatitis infections
- Presence of night blindness, defective vision in bright light, retinal or ophthalmological conditions, or glaucoma
- Prior systemic fenretinide therapy
- T-cell lymphoma types outside specified groups or any natural killer (NK) or B-cell lymphoma
- Use of vitamin A supplements (standard multivitamins allowed)
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
City of Hope Medical Foundation
Duarte, California, United States, 91010
Actively Recruiting
3
University of Southern California
Los Angeles, California, United States, 90007
Actively Recruiting
4
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Northwestern University, Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Barbara Ann Karmanos Cancer Institute Wayne State University
Detroit, Michigan, United States, 48201
Actively Recruiting
8
Columbia University
New York, New York, United States, 10032
Actively Recruiting
9
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
10
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Louis M Scarmoutzos, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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