IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymp… (NCT03902184) | Clinical Trial Compass
CompletedPhase 2
IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma
United States, Austria, Belgium170 participantsStarted 2019-05-22
Plain-language summary
This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.
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
. Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior systemic therapies;
. Prior treatment with mogamulizumab;
. Patients should have blood stage B2 at screening based on central evaluation by flow cytometry;
. Feasibility of obtaining at least one skin biopsy at screening;
. Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF;
. Only for Cohort 2: KIR3DL2 expression in at least one expressing skin lesion based on central evaluation by IHC;
. Patients should have received at least two prior systemic therapies;
. Feasibility of obtaining at least one skin biopsy at screening;
Exclusion criteria
. Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening;
. Receipt of live vaccines within 4 weeks prior to treatment;
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
Objective Response Rate (ORR)
Timeframe: From the first dose until study completion, an expected average of 2 years
. Central nervous system (CNS) lymphoma involvement;
. Prior administration of IPH4102;
. Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study;
. Autologous stem cell transplantation less than 3 months prior to enrollment;
. Prior allogenic transplantation;
. Patients who have undergone major surgery ≤ 4 weeks prior to study entry;