CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma

Trial Title: CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma

NCT ID: NCT06433362

Condition: Peripheral T Cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral

Conditions: Keywords:
Untreated Peripheral T-cell Lymphoma
Mitoxantrone hydrochloride liposome

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: CMOEP
Description: 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;
Arm group label: CMOEP

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.

Detailed description: This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone(CMOEP) in patients with untreated Peripheral T-cell Lymphoma.Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with cyclophosphamide, vincristine, etoposide and prednisone.Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tianjin Cancer Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Status: Recruiting

Contact:
Last name: Huilai Zhang, MD

Phone: +86-18622221228
Email: huilaizhangtz@163.com

Start date: June 1, 2024

Completion date: June 30, 2026

Lead sponsor:
Agency: Tianjin Medical University Cancer Institute and Hospital
Agency class: Other

Source: Tianjin Medical University Cancer Institute and Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06433362