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 range18 Years – 75 Years
SexALL
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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;
✕. Patients with active infection or with obvious B symptoms and high fever should be excluded according to the comprehensive judgment of the investigators;
✕
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
. 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;