Relapsed Cutaneous T Cell LymphomPhase 2NCT02597153
Phase II Clinical Study of PLM60 for the Treatment of Cutaneous T Cell Lymphomas
A Phase 2 study testing Mitoxantrone HCL Liposome Injection in people with Relapsed Cutaneous T Cell Lymphom, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with relapsed cutaneous T cell lymphomasell Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed Cutaneous T Cell Lymphom
- What is being tested?
- Mitoxantrone HCL Liposome Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2020
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects are voluntary and sign the informed consent form;
- ECOG score 0 to 2;
- The expected survival time ≥3 months;
- Patients with cutaneous T-cell lymphoma confirmed by histopathology, with measurable lesions, with or without systemic lymph node involvement; clinical stage IB-IVA;
- The patients previously receive at least once of systemic therapy (including systemic electron beam irradiation or chemotherapy, stem cell transplantation) and do not achieve remission (including remission period shorter than 30 days after the treatment;
- An interval of at least four weeks after the target tumor was treated with chemotherapy, radiotherapy, biological therapy, stem cell transplantation or other study drugs;
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- Subjects at childbearing age agree to take effective contraceptive measures during the study; blood pregnancy test result is negative (except infertility due to menopause or operation);
- Laboratory tests (blood routine, liver and kidney function) meet the following requirements:
- ANC≥ 1.5×109/L; b) PLT ≥ 75×109/L; c) Hb ≥ 9 g/dL; d) Cr) ≤ 1.5x ULN ; e) TBIL ≤ 1.5x ULN; f) AST or ALT ≤2.5 x ULN.
Who cannot join
- Pregnant or lactating women;
- An allergic history to anthracyclines or liposome drugs;
- Disease progression or recurrence after anthracycline treatment within six months before the enrollment;"
- Patients who once used mitoxantrone injection;
- Patients who have used doxorubicin (or pirarubicin) with the total cumulative dose> 360mg/m2, or epirubicin with the total cumulative dose > 600mg/m2;
- Left ventricular ejection fraction is < 50% or < the lower limit of normal; clinically significant QT interval prolongation (>450ms in male, >470ms in female); a past history of cardiac disease caused by anthracyclines; a history of severe heart disease;
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- Concomitant treatment as other anticancer drugs are needed;
- With internal organ involvement (including bone marrow, central nervous system;
- Clinically active infection that can significantly affect the clinical trial;
- Within 6 weeks after organ transplantation or major organ surgery;
- Those who are inappropriate to be enrolled as evaluated by the researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm, Open, Multi-center Phase II Clinical Trial of Mitoxantrone HCL Liposome Injection in Subjects With Relapsed Cutaneous T Cell Lymphomas
To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with relapsed cutaneous T cell lymphomasell
- Conditions
- Relapsed Cutaneous T Cell Lymphom
- Being tested
- Mitoxantrone HCL Liposome Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone HCL Liposome InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone HCL Liposome Injection | Experimental | Each treatment cycle lasts for 28 days with 20mg/m2 Receives: Drug: Mitoxantrone HCL Liposome Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR; complete response + partial response [CR + PR])
Measured: Up to 6 months
Secondary outcomes (4)
Duration of Response (DOR)
Measured: Time from the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented (assessed up to approximately 24 months)
Time to Response (TTR)
Measured: Time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR (assessed up to approximately 24 months)
Progression-free survival (PFS)
Measured: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
Pruritus remission rate
Measured: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: Just one subject enrolled in this trial during one and a half years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Cutaneous T Cell LymphomStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597153
- Sponsor's protocol ID
- CSPC-HE154/PRO/Ⅱ
- Status last verified
- May 2017
- First submitted
- 3 Nov 2015
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open, Multi-center Phase II Clinical Trial of Mitoxantrone HCL Liposome Injection in Subjects With Relapsed Cutaneous T Cell Lymphomas
- ClinicalTrials.gov ID
- NCT02597153
- Acronym / sponsor ID
- CSPC-HE154/PRO/Ⅱ
- Conditions
- Relapsed Cutaneous T Cell Lymphom
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Just one subject enrolled in this trial during one and a half years.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 5 Nov 2015 (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.
To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with relapsed cutaneous T cell lymphomasell
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone HCL Liposome Injection | Experimental | Drug: Mitoxantrone HCL Liposome InjectionEach treatment cycle lasts for 28 days with 20mg/m2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subjects are voluntary and sign the informed consent form;
- ECOG score 0 to 2;
- The expected survival time ≥3 months;
- Patients with cutaneous T-cell lymphoma confirmed by histopathology, with measurable lesions, with or without systemic lymph node involvement; clinical stage IB-IVA;
- The patients previously receive at least once of systemic therapy (including systemic electron beam irradiation or chemotherapy, stem cell transplantation) and do not achieve remission (including remission period shorter than 30 days after the treatment;
Key exclusion criteria (11 listed)
- Pregnant or lactating women;
- An allergic history to anthracyclines or liposome drugs;
- Disease progression or recurrence after anthracycline treatment within six months before the enrollment;"
- Patients who once used mitoxantrone injection;
- Patients who have used doxorubicin (or pirarubicin) with the total cumulative dose> 360mg/m2, or epirubicin with the total cumulative dose > 600mg/m2;
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 HCL Liposome Injection | Drug | Mitoxantrone HCL Liposome Injection |
Primary outcome
Objective response rate (ORR; complete response + partial response [CR + PR])
Time frame: Up to 6 months
4 secondary outcomes
Duration of Response (DOR)
Time frame: Time from the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented (assessed up to approximately 24 months)
Time to Response (TTR)
Time frame: Time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR (assessed up to approximately 24 months)
Progression-free survival (PFS)
Time frame: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
Pruritus remission rate
Time frame: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
Results and safety
The study was stopped early (reason given: Just one subject enrolled in this trial during one and a half years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitoxantrone HCL Liposome Injection in people with Relapsed Cutaneous T Cell Lymphom, 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 24 May 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Just one subject enrolled in this trial during one and a half years.). Results are not available in the source record.
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?
Objective response rate (ORR; complete response + partial response [CR + PR]) (time frame: Up to 6 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 24 May 2017.