Recurrent/Refractory LymphomaPhase 1NCT05173545
Clinical Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection in Recurrent/Refractory Lymphoma Subjects
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Recurrent/Refractory Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, open, randomized parallel group design study to investigate the pharmacokinetic characteristics of Mitoxantrone Hydrochloride liposome injection in the treatment of relapsed/refractory lymphoma after the first administration, and the safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent/Refractory Lymphoma
- What is being tested?
- Mitoxantrone Hydrochloride Liposome Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2019to 28 Oct 2020
- 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
- Subjects must satisfy all the following conditions before enrollment:
- Fully understand the clinical trail and sign the Informed Consent Form (ICF).
- Ages range from 18 to 70 years (including 18 and 70 years), men and women are not limited.
- Histopathologically and/or cytologically diagnosed relapsed/refractory lymphoma patients must undergo at least a first-line standard treatment for relapse or no remission and no better choice for advanced patients.
- ECOG≤2.
- The estimated survival time was at least 3 months.
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- The screening period of laboratory examination meet the following conditions, and 7 days before hematological evaluation during screening，subjects did not receive growth factor (long-acting granulocyte colony-stimulating factor needs 2 weeks interval), platelet or granulocyte transfusion:
- WBC≥3.5×109/L
- ANC≥1.5×109/L
- PLT≥75×109/L
- Hb≥90 g/L
- TBil≤1.5×ULN,If elevated bilirubin is caused by lymphoma invading the liver, the total bilirubin is allowed to be less than 3 x ULN.
- ALT/AST≤2.5×ULN，If the elevation is caused by lymphoma invading the liver, allow it to be less than 5 x ULN.
- The toxicity of previous antineoplastic treatments was restored to ≤ 1 (except hair loss and pigmentation).
- Female subjects were HCG negative in urine or blood (excluding menopause and hysterectomy)，men and women of childbearing age of the subjects take effective contraception during the experiment and 30 days of the end of last treatment.
- Ability to visit on time and follow the procedures, limitations and requirements of the scheme.
Who cannot join
- Subjects consistent with any one of the following conditions:
- Subjects are consistent with one of the following conditions in the previous anti-tumor treatment history:
- Those receiving Mitoxantrone or Liposome-entrapped Mitoxantrone previously.
- Those receiving treatment of Adriamycin or other anthracyclines previously, with the total cumulative dose of > 360 mg/m2 (when converted to 1 mg Adriamycin, other anthracyclines shall be equivalent to 2 mg Epirubicin or 2 mg Pirarubicin or 2 mg Daunorubicin or 0.5 mg Idarubicin);
- Those receiving anti-tumor treatment (including chemotherapy, radiotherapy, hormone therapy or administration of TCM with anti-tumor activity) within 4 weeks prior to the first use of the study drug) or taking part in other clinical trials and accept medication in clinical trials;
- Those who have not yet fully recovered from previous surgical or invasive procedures.
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- Those with other malignant tumors previously or currently (except the non-melanoma skin basal cell carcinoma under effective control, breast/cervical carcinoma in situ, and other malignant tumors not treated but under effective control in the past five years).
- Subjects with known or existing primary or metastatic central nervous system lymphoma or active brain metastasis
- Cardiac dysfunction
- Male: QTc>450 ms, female: QTc>470 ms when ECG examination in the Research Center during the screening period;
- Clinically significant arrhythmias, including but not limited to complete left bundle branch block, Degree II atrioventricular block and PR interval > 250 ms;
- Any risk factor that might increase the QTc interval, e.g. hypokalaemia, inherited long-QT syndrome, with current administration of the drug for prolonging the QT interval or discontinuance for less than 15 days;
- Congestive heart failure of ≥Grade 2 in the New York Heart Association;
- Cardiac ejection fraction less than 50% or less than the lower limit of laboratory examination vale range of Research Center;
- Within six months prior to recruitment occurred myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinical history of severe pericardial disease, or electrocardiographic evidence of acute ischemia or abnormal active conduction system.
- Subjects with known history of immediate or delayed hypersensitivity to the similar drug and excipient of the study drug.
- Hepatitis B and hepatitis C active infection (HBsAg positive and HBsDNA more than 1000 copies / mL; HCV RNA more than 1000 copies / mL).
- Human immunodeficiency virus (HIV) infection.
- Uncontrollable systemic diseases (such as uncontrollable hypertension, diabetes, etc.).
- Pregnant or lactating women.
- Investigator believe that subjects have any conditions that are not suitable for participating in the experiment.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center, open, randomized parallel group design study to investigate the pharmacokinetic characteristics of Mitoxantrone Hydrochloride liposome injection in the treatment of relapsed/refractory lymphoma after the first administration, and the safety and efficacy.
Read the detailed description
The study was divided into three dosage groups: 12 mg/m2, 16 mg/m2 and 20 mg/m2,and three dosage groups were randomly divided into parallel groups.Every 28 days is a administration cycle, a total of 4 cycles.Until the subject's PD or intolerable or withdrawal (whichever occurs first).
In the study before administration of the first cycle to cycle second will set up 16 blood points,to calculate the pharmacokinetic parameters of total mitoxantrone and free mitoxantrone after the first administration.
- Conditions
- Recurrent/Refractory Lymphoma
- Being tested
- Mitoxantrone Hydrochloride Liposome Injection
- 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 Liposome InjectionDrug
Every 28 days is a administration cycle, a total of 4 cycles.Until the subject's PD or intolerable or withdrawal (whichever occurs first).
5% Glucose Injection drugs dissolved in 250 ml, intravenous drip for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome Injection（12 mg/m2） | Experimental | itoxantrone Hydrochloride Liposome Injection（12 mg/m2） Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection |
| Mitoxantrone Hydrochloride Liposome Injection（16 mg/m2） | Experimental | itoxantrone Hydrochloride Liposome Injection（16 mg/m2） Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection |
| Mitoxantrone Hydrochloride Liposome Injection（20mg/m2） | Experimental | itoxantrone Hydrochloride Liposome Injection（20 mg/m2） Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic indexes, Cmax Maximum concentration (Cmax)
aximum concentration (Cmax) of Mitoxantrone Hydrochloride Liposome
Measured: Up to 28 days
Pharmacokinetic indexes, Tmax
Time to Cmax (Tmax) of Mitoxantrone Hydrochloride Liposome
Measured: Up to 28 days
Pharmacokinetic indexes, Maximum concentration (Cmax,u)
Maximum concentration (Cmax,u) of Mitoxantrone Hydrochloride Liposome
Measured: Up to 28 days
Secondary outcomes (1)
progression-free survival(PFS)
progression-free survival(PFS) of Mitoxantrone Hydrochloride Liposome
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first（assessed up to 100 months）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start29 Jul 2019
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent/Refractory 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yunhong Huang, Master, Study director, Cancer Hospital of Guizhou Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173545
- Sponsor's protocol ID
- PLM60-PK
- Status last verified
- Nov 2021
- First submitted
- 31 Jul 2019
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection in Recurrent/Refractory Lymphoma Subjects
- ClinicalTrials.gov ID
- NCT05173545
- Acronym / sponsor ID
- PLM60-PK
- Conditions
- Recurrent/Refractory Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 30 Dec 2021 (actual)
- 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.
This is a single-center, open, randomized parallel group design study to investigate the pharmacokinetic characteristics of Mitoxantrone Hydrochloride liposome injection in the treatment of relapsed/refractory lymphoma after the first administration, and the safety and efficacy.
Detailed description
The study was divided into three dosage groups: 12 mg/m2, 16 mg/m2 and 20 mg/m2,and three dosage groups were randomly divided into parallel groups.Every 28 days is a administration cycle, a total of 4 cycles.Until the subject's PD or intolerable or withdrawal (whichever occurs first).
In the study before administration of the first cycle to cycle second will set up 16 blood points,to calculate the pharmacokinetic parameters of total mitoxantrone and free mitoxantrone after the first administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome Injection（12 mg/m2） | Experimental | Drug: Mitoxantrone Hydrochloride Liposome Injectionitoxantrone Hydrochloride Liposome Injection（12 mg/m2） |
| Mitoxantrone Hydrochloride Liposome Injection（16 mg/m2） | Experimental | Drug: Mitoxantrone Hydrochloride Liposome Injectionitoxantrone Hydrochloride Liposome Injection（16 mg/m2） |
| Mitoxantrone Hydrochloride Liposome Injection（20mg/m2） | Experimental | Drug: Mitoxantrone Hydrochloride Liposome Injectionitoxantrone Hydrochloride Liposome Injection（20 mg/m2） |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Fully understand the clinical trail and sign the Informed Consent Form (ICF).
- Ages range from 18 to 70 years (including 18 and 70 years), men and women are not limited.
- Histopathologically and/or cytologically diagnosed relapsed/refractory lymphoma patients must undergo at least a first-line standard treatment for relapse or no remission and no better choice for advanced patients.
- ECOG≤2.
- The estimated survival time was at least 3 months.
Key exclusion criteria (21 listed)
- Subjects are consistent with one of the following conditions in the previous anti-tumor treatment history:
- Those with other malignant tumors previously or currently (except the non-melanoma skin basal cell carcinoma under effective control, breast/cervical carcinoma in situ, and other malignant tumors not treated but under effective control in the past five years).
- Subjects with known or existing primary or metastatic central nervous system lymphoma or active brain metastasis
- Cardiac dysfunction
- Subjects with known history of immediate or delayed hypersensitivity to the similar drug and excipient of the study drug.
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 InjectionEvery 28 days is a administration cycle, a total of 4 cycles.Until the subject's PD or intolerable or withdrawal (whichever occurs first). 5% Glucose Injection drugs dissolved in 250 ml, intravenous drip for 60 minutes. | Drug | Mitoxantrone Hydrochloride Liposome Injection（12 mg/m2）, Mitoxantrone Hydrochloride Liposome Injection（16 mg/m2）, Mitoxantrone Hydrochloride Liposome Injection（20mg/m2） |
Primary outcome
Pharmacokinetic indexes, Cmax Maximum concentration (Cmax)
Time frame: Up to 28 days
aximum concentration (Cmax) of Mitoxantrone Hydrochloride Liposome
Pharmacokinetic indexes, Tmax
Time frame: Up to 28 days
Time to Cmax (Tmax) of Mitoxantrone Hydrochloride Liposome
Pharmacokinetic indexes, Maximum concentration (Cmax,u)
Time frame: Up to 28 days
Maximum concentration (Cmax,u) of Mitoxantrone Hydrochloride Liposome
1 secondary outcome
progression-free survival(PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first（assessed up to 100 months）
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
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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.
Yunhong Huang, Master study director
Cancer Hospital of Guizhou Province
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 Injection in people with Recurrent/Refractory 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 16 inclusion and 21 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: finished, as of the sponsor's last update on 30 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic indexes, Cmax Maximum concentration (Cmax) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. 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 30 Dec 2021.