Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relap… (NCT07288814) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
43 participantsStarted 2025-12-08
Plain-language summary
To evaluate the safety of mitoxantrone hydrochloride liposome combined with enlonstobart in the treatment of relapsed or refractory peripheral T-cell lymphoma, to determine the optimal dosage of mitoxantrone hydrochloride liposome within the combination regimen, and to assess the efficacy of the combined therapy.
Who can participate
Age range
18 Years – 75 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
. Centrally confirmed histopathological/cytologic diagnosis of PTCL with the following subtypes:
. Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);
. Systemic anaplastic large cell lymphoma (ALK+ and ALK-);
. Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS;
. and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.
. Voluntary participation in clinical study; Fully understand and informed the study and sign the written informed consent;
. Age ≥18 years old, and ≤ 75 years old, regardless of gender;
. Met the criteria of relapsed/refractory lymphoma: Relapsed lymphoma was defined as relapsed lymphoma more than 6 months after achieving complete remission (CR) after initial chemotherapy. Refractory lymphoma was defined as any of the following criteria: 1) tumor shrinkage \< 50% or disease progression after at least 4 courses of standard chemotherapy; 2) achieved CR with standard chemotherapy, but relapsed within half a year;
Exclusion criteria
. Patients with hemophagocytic lymphohistiocytosis;
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
Phase Ib: Dose limited toxicities (DLTs)
Timeframe: Cycle 1 (28 days)
2
Phase Ib: Recommended Phase II Dose (RP2D)
Timeframe: through Phase Ib study completion, an average of 3 months
. Patients with active infection or with obvious B symptoms and high fever should be excluded according to the comprehensive judgment of the investigators;
. The subject's previous history of antineoplastic therapy meets one of the following conditions:
. Failure to achieve CR or PR after previous treatment with mitoxantrone or mitoxantrone liposome, or relapse within 6 months after treatment;
. Prior treatment with anthracyclines or anthraquinones and cumulative dose of doxorubicin \> 550 mg/m2 (liposomal doxorubicin \> 2000 mg/m2, epirubicin \> 1000 mg/m2, pirarubicin \> 1000 mg/m2, mitoxantrone \> 160 mg/m2);
. Received anti-tumor treatment (including chemotherapy, targeted therapy, traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives (whichever came first) before the first use of the study drug;
. patients who received autologous hematopoietic stem-cell transplantation or allogeneic hematopoietic stem-cell transplantation within 100 days of the first dose of treatment;
. Hypersensitivity reaction to any study drug or its components;