Malignant LymphomaPhase 1NCT02131688
Phase I Study of Mitoxantrone Hydrochloride Liposome Injection
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome in people with Malignant Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to determine the maximum tolerated dose,the safety and effectiveness of Mitoxantrone Hydrochloride Liposome Injection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Lymphoma
- What is being tested?
- Mitoxantrone Hydrochloride Liposome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital ,Chinese Academy of Mddical Sciences
Beijing
Yuankai Shi, Ph.D, 010-87788701
Yuankai Shi, Ph.D
About this study
Official title: Phase I Dose Escalation Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Malignant Lymphoma
The purpose of this study is to determine the maximum tolerated dose,the safety and effectiveness of Mitoxantrone Hydrochloride Liposome Injection.
Read the 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.
- Conditions
- Malignant Lymphoma
- Being tested
- Mitoxantrone Hydrochloride Liposome
- Keywords
- safety;malignant lymphoma;
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride LiposomeDrug
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome | Experimental | Not described Receives: Drug: Mitoxantrone Hydrochloride Liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection
Measured: 4 months
Secondary outcomes (1)
Objective Response Rate
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMay 2013
- Primary completionAug 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant LymphomaStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Ph.D, Principal investigator, Cancer Hospital ,Chinese Academy of Mddical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131688
- Sponsor's protocol ID
- CSPC-HE14Ⅰ
- Status last verified
- Mar 2014
- First submitted
- 4 May 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Malignant Lymphoma
- ClinicalTrials.gov ID
- NCT02131688
- Acronym / sponsor ID
- CSPC-HE14Ⅰ
- Conditions
- Malignant Lymphoma
- Keywords
- safety;malignant lymphoma;
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome | Experimental | Drug: Mitoxantrone Hydrochloride Liposome |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome | Drug | Mitoxantrone Hydrochloride Liposome |
Primary outcome
Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection
Time frame: 4 months
1 secondary outcome
Objective Response Rate
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuankai Shi, Ph.D principal investigator
Cancer Hospital ,Chinese Academy of Mddical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome in people with Malignant Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.