Clinical trial NCT02131688: Phase I Study of Mitoxantrone Hydrochloride Liposome Injection
Official title: Phase I Dose Escalation Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Malignant Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Malignant Lymphoma
Keywords: safety;malignant lymphoma;
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection
timeFrame: 4 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 4 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital ,Chinese Academy of Mddical Sciences
Study officials:
affiliation: Cancer Hospital ,Chinese Academy of Mddical Sciences
name: Yuankai Shi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: