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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
197
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.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGComplete Response Rate (CRR)
Response is assessed according to the 2014 lugano criteria.Percentage of participants with complete response was determined on 2014 Lugano criteria.
Time frame: 3 years
Overall Response Rate (ORR)
Response is assessed according to the 2014 lugano criteria.The total percentage of patients with complete response(CR )and partial response(PR).
Time frame: 3 years
Progression-Free-Survival (PFS)
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.
Time frame: 3 years
Duration of Response (DOR)
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.
Time frame: 3 years
Overall survival (OS)
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.
Time frame: 3 years
Progression of disease within 2 years(POD24)
The rate of patients with disease progression within 24 months of receiving first-line treatment at the start of enrollment.
Time frame: 3 years
Haiwen Huang
CONTACT
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Treatment-emergent adverse events (TEAEs)
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.
Time frame: From the initiation of the first dose to 28 days after the last dose
Changes in cardiac safety indicators
The change value of LVEF% from baseline, and its mean, median, standard deviation, maximum and minimum values were statistically described.
Time frame: 3 years