Treatment for untreated Peripheral T-cell Lymphoma using CMOEP
A Single Arm, Open Label, Multi-center Study of Mitoxantrone Hydrochloride Liposome With Cyclophosphamide, Vincristine, Etoposide and Prednisone (CMOEP) in Treatment-Naive Patients With Peripheral T-Cell Lymphoma
This study is testing a new treatment called CMOEP to see if it can help people with untreated Peripheral T-cell Lymphoma feel better and improve their health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Cyclophosphamide, Prednisone |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06433362 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a treatment regimen called CMOEP, which combines mitoxantrone hydrochloride liposome with cyclophosphamide, vincristine, etoposide, and prednisone, in patients with untreated Peripheral T-cell Lymphoma. The study is a single-arm, open-label, multicenter trial, meaning all participants will receive the same treatment without a control group. Participants will undergo a maximum of six treatment cycles, each lasting 21 days, to assess the treatment's effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a histologically confirmed diagnosis of untreated Peripheral T-cell Lymphoma.
Not a fit: Patients who have previously received treatment for Peripheral T-cell Lymphoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with untreated Peripheral T-cell Lymphoma.
How similar studies have performed: Other studies have shown promise with similar treatment approaches, but this specific combination is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Subjects fully understand and voluntarily participate in this study and sign informed consent. 2\. Age ≥18, ≤70years(for 65-70 years old, researchers need to comprehensively evaluate the physical fitness and tolerance of patients), 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(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10\^9/L, Platelet count (PLT) ≥50×10\^9/L, Hemoglobin(HB)≥ 75g/L). 9.Total Serum creatinine (Scr) ≤1.5X upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN(For patients with liver invasion ≤5X ULN), bilirubin (TBIL)≤1.5X ULN(For patients with liver invasion ≤3X ULN ). Exclusion Criteria: * 1.Subjects with a history of prior antitumor therapy. 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.
Where this trial is running
Tianjin
- Tianjin Cancer Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Jingwei Yu
- Email: jingweiyu@pku.org.cn
- Phone: 86-15022015208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.