Clinical trial · Interventional
CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma
Phase I Cinical Sudy of Lposomal Mitoxantrone Hydrochloride Combined With Cyclophosphamide, Vincristine, Etoposide and Prednisone (CMOEP) in Previously Untreated Peripheral T-cell Lymphoma
NCT05458180CI-TRIAL-00059651unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, single arm, multicenter, dose-escalation clinical study to evaluate the safety and efficacy of CMOEP in patients with untreated Peripheral T-cell Lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lposomal mitoxantrone hydrochloride,Cyclophosphamide,Vincristine,Etoposide and Prednisone(CMOEP) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CMOEP
- description
- dose-escalation: Untreated Peripheral T-cell Lymphoma Patients will receive sequentially higher doses of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone for 6 cycles (planned) (21 days per cycle). The initial dose of liposomal mitoxantrone hydrochloride is 15 mg/m2.
- interventionNames
- Drug: Lposomal mitoxantrone hydrochloride,Cyclophosphamide,Vincristine,Etoposide and Prednisone(CMOEP)
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Cycle 1 (21 days)
- description
- Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in CMOEP
Secondary outcomes (5)
- measure
- Dose limited toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects fully understand and voluntarily participate in this study and sign informed consent. 2. Age ≥18, ≤65years, no gender limitation. 3. Expected survival ≥ 3 months. 4. Histologically confirmed diagnosis of Peripheral T-cell lymphoma: 1) Peripheral T-cell lymphoma unspecified (ptcl-NOS) 2) Angioimmunoblastic T-cell lymphoma (AITL) 3) Anaplastic large T-cell lymphoma (ALCL), ALK+ 4) Anaplastic large T-cell lymphoma (ALCL), ALK- 5) Other subtypes of PTCL that the investigator think can be included in the group. 5. No previous treatment for PTCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except for local radiotherapy to alleviate tumor related symptoms), surgical treatment. 6. Subjects must have at least one evaluable or measurable lesion per lugano2014 criteria: for lymph node lesions, the length and diameter should be \> 1.5cm; For non-lymph node lesions, the length and diameter should be \> 1.0cm. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. 8. The following baseline laboratory criteria are required: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count (PLT) ≥75×10\^9/L, Hemoglobin(HB)≥ 90 g/L. 9. Total Serum creatinine (Scr) ≤1.5X upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN, bilirubin (TBIL)≤1.5X ULN. Exclusion Criteria: 1. The subject had previously received any of the following anti-tumor treatments:1)Subjects who have been treated with mitoxantrone or mitoxantrone liposomes;2)Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin was more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin). 2. Hypersensitivity to any study drug or its components. 3. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.) 4. Heart function and disease meet one of the following conditions:1)Long QTc syndrome or QTc interval \> 480 ms;2)Complete left bundle branch block, grade II or III atrioventricular block;3)Serious and uncontrolled arrhythmias requiring drug treatment;4)New York Heart Association grade ≥ II;5)Cardiac ejection fraction (LVEF)\< 50%;6)A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment. 5. Hepatitis B and hepatitis C active infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than 1x10\^3 copy/mL; hepatitis C virus RNA high than 1x10\^3 copy/mL). 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive). 7. Patients with other malignant tumors, except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ and other tumor during the past 5 years. 8. Patients with primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma. 9. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures. 10. Unsuitable subjects for this study determined by the investigator.
References
Publications (1)
- DERIVEDYu J, Sun X, Gao G, Yu L, Wang J, Qiu L, Qian Z, Li W, Zhang H. CMOEP regimen in the treatment of untreated peripheral T-cell lymphoma: a multicenter, single-arm, phase I study. Front Immunol. 2025 Apr 11;16:1551723. doi: 10.3389/fimmu.2025.1551723. eCollection 2025. PMID 40292284