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New treatment option for T-cell Lymphoma
Official title Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT04234048
What this study is testing
What is Fenretinide?
Fenretinide is an investigational medicine, being studied as a potential treatment for t-cell lymphoma.
Also referred to as nanoFenretinide, ST-001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All patients must have histologically or cytologically confirmed diagnosis of the following specific types of T-cell lymphomas (TCL):
- 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...
- 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...
You likely can't join 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...
- 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...
- 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...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart...
See the full eligibility criteria
Who can join
- All patients must have histologically or cytologically confirmed diagnosis of the following specific types of T-cell lymphomas (TCL):
- 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...
- 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...
- 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.
- For primary cutaneous lymphomas, stage IB, II, III and IV according to the TNMB system (Appendix C) are eligible. For primary nodal lymphomas, patients with stages II-IV according to the Ann Arbor staging system are...
- Minimum of 4 weeks must have elapsed since last systemic treatment or radiation therapy treatment (or 6 weeks for any nitrosourea-containing regimens), and patients must have recovered from all toxicity of last...
- Age ≥18 years. Both genders are included. However, women of childbearing potential must have a negative B-HCG serum pregnancy test (see Section 10 Study Calendar, Pre-Study, footnote b) and agree to use effective...
- ECOG performance status 0-1 (Karnofsky ≥60%, see Appendix B).
- Life expectancy greater than 6 months.
- Patients must have normal organ and marrow function as defined below:
- Leukocytes ≥ 3,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Platelets ≥ 100,000/μL
- Total bilirubin within normal institutional limits. Patients with total bilirubin ≤ 1.5 X upper limit of normal are eligible
- AST (SGOT) and ALT (SGPT) within institutional upper limit of normal
- Creatinine clearance ≥60 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation Or if the patient were to have bone marrow involved NHL, the hematological requirements should be as listed below:
- Absolute neutrophil count ≥ 500/μL
- Platelets ≥ 50,000/μL
- Triglyceride blood level (fasting) \<300mg/dL at time of enrollment (normal: \<150mg/dL; borderline high = 150-199mg/dL; high = 200-499mg/dL; very high = 500mg/dL or higher).
- ST-001 is an experimental drug and the risks to the unborn or nursing child are unknown. Pregnant or breastfeeding women cannot take part in this study. Women of childbearing age are required to have a blood and/or...
- Informed consent of the patient or a legal authorized representative (LAR) must be obtained prior to any study related procedures.
What rules you out
- 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...
- 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...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart classification III/IV), unstable angina pectoris, cardiac arrhythmia, QTc...
- Pregnant women are excluded from this study because ST-001is a retinoid agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing...
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ST-001. Appropriate studies will be undertaken in patients receiving combination...
- Patients with any active hepatitis infections.
- Presence of nyctalopia (night blindness), or hemeralopia (defective vision in a bright light, 'day blindness') at enrollment, or any other retinal, ophthalmological condition (eg: retinitis pigmentosa, choroidoretinitis...
- Patients who have received prior fenretinide systemic therapy
- Patients with T-cell lymphoma types other than those specified in section 3.1.1 are not eligible even if they have cutaneous dissemination. Similarly, patients with any type of natural killer (NK)- or B-cell lymphoma...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Duarte, California, United States; Los Angeles, California, United States; Aurora, Colorado, United States; Chicago, Illinois, United States; Ann Arbor, Michigan, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.