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