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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMOP±R | Experimental | All enrolled patients. All patient who signed the consent form for participation to the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMOP±R | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CRR) | Response is assessed according to the 2014 lugano criteria.Percentage of participants with complete response was determined on 2014 Lugano criteria. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 years |
| Progression-Free-Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiwen Huang | Contact | 13962154846 | huanghaiwen@suda.edu.cn | |
| Haiwen Huang | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Haiwen Huang | The First Affiliated Hospital of Soochow University, Suzhou, China | Principal Investigator |
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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.
| 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. | 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. | 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. | 3 years |
| 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. | 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. | 3 years |