Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides (NCT05414500) | Clinical Trial Compass
SuspendedPhase 1
Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides
Stopped: IRB audit
United States10 participantsStarted 2023-05-01
Plain-language summary
This is an open label, single center, non-randomized dose de-escalation phase I study of combination of BV and Mogamulizumab.
The primary objective of the study is to assess the safety and tolerability of the combination. The primary objective is also to explore safe dose of combination for future expansion.
Who can participate
Age range
19 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
. Able to understand and comply with study procedure, understand the risks involved in the study and provide written informed consent before the first study-specific procedure
. Men or women \>18 years with pathologically confirmed diagnosis of Sezary Syndrome or Mycosis fungoides
. Must have CD30 positivity on recent biopsy of \>1%
. Stage II-IV, for skin only disease \>20% BSA should be involved, large cell transformation is allowed.
. Must have received at least one prior systemic therapy like bexarotene, interferons, ECP, methotrexate, Gemcitabine, Vorinostat etc. (patients who have received only skin directed therapy are not allowed)
. ECOG performance status of 0,1 or 2
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.
1This trial is currently listed as 'suspended' — can you find out why it was suspended and whether that suspension raises any safety concerns I should know about before considering it?
2Since this is a Phase 1 trial primarily measuring rates of adverse events and serious adverse events, does that mean the main goal right now is figuring out safety rather than proving the treatment works, and what does that mean for the risk I'd be taking on?
3Both mogamulizumab and brentuximab vedotin are being combined here — can you walk me through what side effects are already known for each of these drugs separately, and how combining them might increase those risks?
4Given that this trial is suspended and may not be actively enrolling, are there other trials or approved treatments for my stage of cutaneous T cell lymphoma or mycosis fungoides that we should be exploring right now instead?
5If the suspension is eventually lifted and this trial does become an option, how would the demands of participating — like the visit schedule and monitoring for adverse events — fit with my current health situation and daily life?
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
Rates of Adverse Events
Timeframe: through study completion, an average of 1 year
2
Rates of Serious Adverse Events
Timeframe: At the end of cycle 1 (each cycle is 28 days)
. Adequate organ function at screening defined as follows
. Patients must have completed any chemotherapy, radiation therapy, or biologic therapy specific to their neoplasm ≥ 1 weeks or 5 half-lives (whichever is longer). Radiation for palliation on symptomatic lesions has no wash out period.
Exclusion criteria
. Prior exposure of BV \< 6 months ago, or Moga. Prior exposure of BV is allowed if it is \>6 months ago and CD30+ in \>1% of in biopsy after last BV
. Active CNS involvement by MF/Sezary Syndrome
. Should not be receiving any other investigational agents. Prior use of investigational agents or other systemic therapy is allowed if it is \>1 week ago or 5x half-life of the investigational agent whichever is shorter.
. Pregnant and lactating women
. Patients with clinically significant illness which would compromise participation in the study.
. Severe or uncontrolled systemic infection. (active skin infections in CTCL/MF patients are allowed once course of antibiotics is completed and infection is under control)
. Known HIV infection
. Active Hepatitis B or C infection with active virus detected in blood. Hepatitis B core positive and HBsAg positivity are allowed if HBV DNA in blood is negative. Patient should be on antiviral prophylaxis. Hepatitis C positivity is allowed but HCV DNA by PCR must be negative in peripheral blood.