Malignant Lymphoma
Conditions
Keywords
safety;malignant lymphoma;
Brief summary
The purpose of this study is to determine the maximum tolerated dose,the safety and effectiveness of Mitoxantrone Hydrochloride Liposome Injection.
Detailed description
The trial of the dose escalation method is from 18mg/m2 until the maximum tolerated dose and every 3 patient is a dose group.
Interventions
DRUGMitoxantrone Hydrochloride Liposome
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients must compliance with the requirements and restrictions listed in the consent form * Patients with Pathology and / or cytologically proven malignant lymphoma * Patients must be 18-70 years old ,both male and female * Failure of standard chemotherapy * Patients have no better choice and may be benefit from the use of anthracyclines * Patients with Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2 * Objective tumor from the last chemotherapy, biological therapy or other experimental interval treatment least 4 weeks * Expected survival time ≥ 3 months * Patients agreed to take effective contraceptive measures during the trial * Blood routine, liver and kidney function, cardiac function examination in accordance with the following requirements.
Exclusion criteria
* Pregnancy and breast-feeding women * Multiple sclerosis * Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease * Patients with heart disease induced by anthracycline * Patients requiring other antineoplastic treatment * Patients with temperature above 38 degrees or active infection that may effects in clinical tests * Patients are allergic to anthracycline and liposomal drugs * Patients are allergic to eggs,egg products,soybean and soybean products * Patients with uncontrolled primary or metastatic brain tumorsMultiple sclerosis * Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease * Patients with heart disease induced by anthracycline * Patients requiring other antineoplastic treatment * Patients with temperature above 38 degrees or active infection that may effects in clinical tests * Patients are allergic to anthracycline and liposomal drugs * Patients are allergic to eggs,egg products,soybean and soybean products * Patients with uncontrolled primary or metastatic brain tumors * Total amount of Doxorubicin(or Pirarubicin)≥360mg/m2,Epirubicin ≥600mg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate | 4 months |
Countries
China
Outcome results
None listed