A Study of MT-2111 in Patients With Relapsed/Refractory DLBCL (NCT05658562) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of MT-2111 in Patients With Relapsed/Refractory DLBCL
Japan46 participantsStarted 2023-01-30
Plain-language summary
\[Phase I part\] To investigate the safety, tolerability, and pharmacokinetics of MT-2111 monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In addition, the dose to be used in the Phase II part will be confirmed.
\[Phase II part\] To evaluate the efficacy of MT-2111 monotherapy in patients with relapsed/refractory DLBCL. In addition, the safety and pharmacokinetics will be investigated.
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:
* Patients who were diagnosed pathologically with DLBCL, NOS, DLBCL transformed from indolent B-cell lymphoma, or high-grade B-cell lymphoma with DLBCL morphology and with MYC and BCL2 and/or BCL6 rearrangements, based on the 2017 WHO classification.
* Patients with relapsed or refractory disease despite 2 or more prior systemic therapies.
* Japanese patients aged ≥ 18 years at the time of informed consent. For Japanese subjects, it should be confirmed that the parents who are related by blood to the subject must be Japanese.
* Patients who have a lesion that can be assessed for staging and evaluated for response according to the Lugano criteria (2014). A lesion that has received radiotherapy as the most recent treatment will be considered as a measurable lesion only when progression has been documented following completion of the radiotherapy.
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.
Exclusion Criteria:
* Patients with a pathological diagnosis of Burkitt's lymphoma.
* Patients with bulky disease with the longest dimension of ≥ 10 cm.
* Patients with a history or complication of post-transplant lymphoproliferative disorders.
* Patients with lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease.
* Patients complicated with other active malignancies or patients with a history of other malignancies within 3 years before informed c…
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.
1Since this is a Phase 1/2 trial of MT-2111, what is currently known about its safety profile, and what side effects have been reported so far in the patients who have already been treated?
2This trial is active but no longer enrolling new patients — does that mean I've missed the window to participate, or are there related studies or expanded access options worth exploring?
3How does MT-2111 work differently from the treatments I've already tried, and given that my lymphoma has relapsed or not responded before, what makes this approach potentially worth pursuing?
4The trial measures overall response rate as its main goal — what does that mean in practical terms for my situation, and how would my doctors monitor whether I'm responding during treatment?
5Are there standard-of-care options or other clinical trials still open to enrollment that my care team thinks I should consider alongside or before looking into a study like this one?
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
Overall response rate (ORR) by independent central review
Timeframe: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)