TerminatedPhase 1/2

Mogamulizumab and Extracorporeal Photopheresis for the Treatment of Sezary Syndrome or Mycosis Fungoides

Stopped: Lack of funding

United States5 participantsStarted 2021-04-21

Plain-language summary

This phase Ib/II trial investigates the side effects of mogamulizumab and extracorporeal photopheresis and to see how well they work in treating patients with Sezary syndrome or mycosis fungoides. Mogamulizumab (a humanized antibody) binds to CCR4, a protein often found in high amounts on T-cell lymphoma cells. Binding to these cells may slow their growth, as well as mark them for attack by the immune system. Extracorporeal photopheresis (ECP) is a standard treatment for cancers that affects the skin, and may work by killing some lymphoma cells directly and by boosting the body's immune response against other lymphoma cells. Giving mogamulizumab together with ECP may work better in treating patients with Sezary syndrome or mycosis fungoides compared to either therapy alone.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Histopathologic diagnosis of primary cutaneous T-cell non-Hodgkin lymphoma (CTCL) (mycosis fungoides \[MF\] or Sezary syndrome \[SS\]), confirmed by skin biopsy, or lymph node, or blood assessment, of current disease * CTCL stage 3A-4A2 disease at study entry according to International Society of Cutaneous Lymphoma (ISCL)/European Organization for Research and Treatment of Cancer (EORTC) * Newly diagnosed or =\< 3 different lines of systemic therapy * Systemic therapy includes oral retinoids, interferon, pralatrexate, methotrexate, vorinostat, romidepsin, single or multi-agent chemotherapy or other oral, IV or subcutaneous treatments used to treat systemic disease * A line of therapy is defined as any therapy or group of therapies that was started or changed for lack of response, disease progression, or intolerance * Prior cytotoxic chemotherapy excluding low dose methotrexate * A minimum washout period of 4 weeks after previous CTCL therapy is recommended prior to the first dose of combination therapy * Willing and able to comply with all aspects of the protocol * Provide voluntary written informed consent prior to any study specific screening procedures * Absolute neutrophil count (ANC) \>= 500/mcL (within 16 days of cycle 1 day 1) * Platelets \>= 50,000/mcL (within 16 days of cycle 1 day 1) * Total bilirubin =\< 3 institutional upper limit of normal (ULN) (w…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of dose-limiting toxicities (DLT's) (Phase Ib)

Timeframe: Up to 6 weeks

Rate of overall response lasting at least 6 months (ORR6) (Phase II)

Timeframe: Up to 3 years post treatment

Trial details

NCT IDNCT04676087

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-11

View on ClinicalTrials.gov More Mycosis Fungoides trials