RecruitingPhase 2NCT06433362

CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

115 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Peripheral T Cell Lymphoma

Summary

This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOEP in patients with untreated peripheral T-cell lymphoma.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new chemotherapy regimen called CMOEP as a first-line treatment for people with a type of blood cancer called peripheral T-cell lymphoma (PTCL), which is a cancer of certain white blood cells. **You may be eligible if...** - You are between 18 and 70 years old (those aged 65–70 will be evaluated individually) - You have been diagnosed with peripheral T-cell lymphoma, confirmed by tissue biopsy (including PTCL-NOS, AITL, ALCL ALK+, ALCL ALK-, or similar subtypes) - You have not received any prior treatment for PTCL (no chemotherapy, targeted therapy, immunotherapy, or radiation for lymphoma) - Your expected survival is at least 3 months - Your general health and organ function meet the study requirements **You may NOT be eligible if...** - You have previously been treated for this type of lymphoma - You have serious infections, significant heart problems, or other major organ failure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCMOEP

Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1, every 3 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m\^2) on day 1,every 3 weeks; Drug: Vincristine Vincristine (1.4mg/ m2，Max dose 2mg) will be administered by an intravenous injection on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 3 mg/m2, the maximum dose of 4mg),every 3 weeks; Drug: Etoposide Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3,every 3 weeks;