TSEB and Brentuximab for Treatment of Mycosis Fungoides & Sezary Syndrome (NCT02822586) | Clinical Trial Compass
CompletedPhase 1
TSEB and Brentuximab for Treatment of Mycosis Fungoides & Sezary Syndrome
United States5 participantsStarted 2016-12-19
Plain-language summary
The purpose of this study is to evaluate the cutaneous toxicity and treatment response associated with administering concurrent TSEB and brentuximab vedotin in patients with mycosis fungoides or Sézary Syndrome.
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:
* Histologically confirmed CD30-positive (defined in this study as ≥ 1% expression) Mycosis Fungoides (including large cell transformation variant) or Sezary Syndrome who have either:
* Received prior systemic therapy (for whom commercial supply of brentuximab vedotin is available) OR
* Not received prior systemic therapy (who will receive brentuximab vedotin free of charge)
* Any of the disease stages listed below
* Stage IB disease that meets one of the following criteria:
* Plaque disease (ie,T2b staging)
* Diffuse skin involvement with indication for TSEB (plaque disease with or without patches)
* Not appropriate for treatment with focal therapies
* One prior course of low-dose TSEB or one prior course of systemic chemotherapy regimens (excluding brentuximab)
* Stage IIA, IIB, or IIIA that meets ONE or BOTH of the following criteria:
* Patient is a candidate for treatment with low-dose TSEB
* Patient is a candidate for systemic therapy
* IIIB or IVA disease requiring systemic therapy
* Transformed CTCL
* Candidate for TSEB based on investigator determination
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3, if the performance status of 3 is due to skin disease involvement
* Adequate bone marrow function as defined below:
* Absolute neutrophil count (ANC) ≥ 1000/mm3
* Platelets \> 75,000/mm3
* Hemoglobin ≥ 9 g/dL
* Note: Patients requiring transfusion to meet the hemoglobin requiremen…
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
1
Cutaneous toxicity of combining TSEB and brentuximab vedotin in patients with MF or SS (Cohorts A and B).
Timeframe: 6 months
2
Number of patients who achieved Complete Response (CR) and Partial Response(PR)