NHL
Conditions
Keywords
newly diagnosed non-Hodgkin's lymphoma, Mitoxantrone hydrochloride liposome
Brief summary
This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOP±R in patients with newly diagnosed non-Hodgkin's 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, Prednisone and/or Rituximab(CMOP±R) in patients with newly diagnosed non-Hodgkin's lymphoma. Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with cyclophosphamide, vincristine, prednisone and/or Rituximab. Each cycle consists of 28 days. A maximum of 8 cycles(6×CMOP±R+2×R) of therapy are planned.
Interventions
DRUGCMOP±R
Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1, every 4 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m\^2) on day 1, every 4 weeks; Drug: Vincristine Vincristine (1.4mg/ m2，Max dose 2mg) will be administered on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 2-3 mg/m2 on day 1), every 4 weeks; Drug: Prednisone Prednisone (100 mg) will be taken orally from day 1-5(Or equivalent dose of dexamethasone at 15mg), every 4 weeks; Drug: Rituximab Rituximab (375mg/m\^2) on day 0, every 4 weeks, only with CD20-positive lymphomas are evaluated by the investigator.
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients fully understand this study, voluntarily participate and sign the informed consent (ICF); * Age: 18-75 years old; * Expected survival time ≥ 3 months; * Histopathologically diagnosed newly diagnosed non-Hodgkin's lymphoma; * Must have at least one evaluable or measurable lesion that meets the Lugano 2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter \>1.5cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter \>1.0cm; * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2. * Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count (PLT) ≥75×10\^9/L, Hemoglobin(HB)≥ 80 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); * Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal value (for patients with liver invasion ≤ 5 times the upper limit of normal value); total bilirubin ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3 times the upper limit of normal value);
Exclusion criteria
* Subjects have previously received anthracyclic drug pretreatment; * Hypersensitivity to any study drug or its components; * Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); * Heart function and disease meet one of the following conditions: a) long QTc syndrome or QTc interval \>480 ms; b) complete left bundle branch block, grade II or III atrioventricular block; c) Serious and uncontrolled arrhythmias requiring drug treatment; d) New York Heart Association grade ≥ III; e) Cardiac ejection fraction (LVEF) lower than 50%;f) 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. * Active hepatitis B and C infection (positive hepatitis B virus surface antigen and more than 1x10\^3 copies/mL of hepatitis B virus DNA; more than 1x10\^3 copies/mL of hepatitis C virus RNA); * Human immunodeficiency virus (HIV) infection (positive HIV antibody); * Suffering from other malignant tumors in the past or at the same time (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years); * Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment; * Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; * Other researchers judge not to Eligibility to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (CRR) | 3 years | Response is assessed according to the 2014 lugano criteria.Percentage of participants with complete response was determined on 2014 Lugano criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 3 years | Response is assessed according to the 2014 lugano criteria.The total percentage of patients with complete response（CR ）and partial response（PR). |
| Progression-Free-Survival (PFS) | 3 years | From the time subjects were enrolled to the time of disease progression (in any way) or death from any cause.Progression-free survival (PFS) was analyzed using Kaplan-Meier method, and 95% bilateral confidence intervals were calculated. |
| Duration of Response (DOR) | 3 years | The time between meeting the criteria for treatment effectiveness (first recorded complete or partial response) and the first clear recurrence or progression.Duration of response (DoR) was analyzed using Kaplan-Meier method, and 95% bilateral confidence intervals were calculated. |
| Overall survival (OS) | 3 years | From the date of inclusion to date of death, irrespective of cause.Overall survival (OS) was analyzed using Kaplan-Meier method, and 95% bilateral confidence intervals were calculated. |
| Progression of disease within 2 years(POD24) | 3 years | The rate of patients with disease progression within 24 months of receiving first-line treatment at the start of enrollment. |
| Treatment-emergent adverse events (TEAEs) | From the initiation of the first dose to 28 days after the last dose | The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.Hematologic and non-hematologic toxicity.To identify the incidence of TEAEs with NCI-CTC AE 5.0 standard. |
| Changes in cardiac safety indicators | 3 years | The change value of LVEF% from baseline, and its mean, median, standard deviation, maximum and minimum values were statistically described. |
Countries
China
Contacts
CONTACTHaiwen Huang
PRINCIPAL_INVESTIGATORHaiwen Huang
The First Affiliated Hospital of Soochow University, Suzhou, China
Outcome results
None listed