GVM±R in Patients With Relapsed or Refractory Aggressive NHL
Non Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Non Hodgkin Lymphoma focused on measuring GVM±R, liposomal mitoxantrone hydrochloride
Eligibility Criteria
Inclusion Criteria:
- Subjects fully understand and voluntarily participate in this study and sign the informed consent
- Age ≥18, ≤70years, no gender limitation
- Expected survival ≥ 3 months;
- Histologically confirmed diagnosis of aggressive NHL.
- Subjects with relapsed or refractory NHL. Relapsed disease is defined as the disease relapsing after CR or PR, and the duration of prior response is more than 6 months. Refractory disease can be confirmed if any of the following conditions are met: 1) no PR or CR has been obtained after previous treatment; 2) CR / PR was achieved after prior therapy, but recurred within 6 months; 3) Recurrence after hematopoietic stem cell transplantation.
- 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;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) : 0-1
- The following baseline laboratory criteria are required: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥75×109/L, Hemoglobin(HB)≥ 80g/L, Total bilirubin (TBIL) ≤1.5X upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN, Serum creatinine (Scr) ≤1.5X ULN.
Exclusion Criteria:
The subject had previously received any of the following anti-tumor treatments:
- Subjects who have been treated with mitoxantrone or mitoxantrone liposomes;
- 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);
- Subjects who received anti-tumor treatment (including chemotherapy, targeted therapy, glucocorticoid, traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received trial drugs within 4 weeks before the first administration of the study drugs;
- Subjects who received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days of the first administration of study drugs;
- Hypersensitivity to any study drug or its components;
- Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)
Heart function and disease meet one of the following conditions:
- Long QTc syndrome or QTc interval > 480 ms;
- Complete left bundle branch block, grade II or III atrioventricular block;
- Serious and uncontrolled arrhythmias requiring drug treatment;
- New York Heart Association grade ≥ III;
- Cardiac ejection fraction (LVEF)< 50%;
- 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.
9. Hepatitis B and hepatitis C active infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than 1x103 copy/mL; hepatitis C virus RNA high than 1x103 copy/mL) 10. Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive) 11. Patients with other malignant tumors, except for effectively controlled non- melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ or other tumors without treatment during the past 5 years.
12. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 13. Unsuitable subjects for this study determined by the investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Liposomal mitoxantrone hydrochloride 16 mg/m^2 (with a caret included)
Liposomal mitoxantrone hydrochloride 18 mg/m^2 (with a caret included)
Liposomal mitoxantrone hydrochloride 20 mg/m^2 (with a caret included)
Liposomal mitoxantrone hydrochloride 22 mg/m^2 (with a caret included)