- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02597153
Phase II Clinical Study of PLM60 for the Treatment of Cutaneous T Cell Lymphomas
May 23, 2017 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Beijing Cancer Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Mitoxantrone HCL Liposome Injection
Each treatment cycle lasts for 28 days with 20mg/m2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (ORR; complete response + partial response [CR + PR])
Time Frame: Up to 6 months
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Up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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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)
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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)
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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)
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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
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Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
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Pruritus remission rate
Time Frame: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
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Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
October 1, 2020
Study Registration Dates
First Submitted
November 3, 2015
First Submitted That Met QC Criteria
November 3, 2015
First Posted (Estimate)
November 5, 2015
Study Record Updates
Last Update Posted (Actual)
May 24, 2017
Last Update Submitted That Met QC Criteria
May 23, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Mitoxantrone
Other Study ID Numbers
- CSPC-HE154/PRO/Ⅱ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapsed Cutaneous T Cell Lymphom
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Kyowa Kirin, Inc.Active, not recruitingCutaneous T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma, RelapsedUnited States, United Kingdom, Spain, France, Italy
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Samsung Medical CenterCompletedRelapsed and/or Refractory Cutaneous T-cell LymphomaKorea, Republic of
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National Cancer Institute (NCI)Active, not recruitingCutaneous T-Cell Lymphoma | Peripheral T-Cell Lymphoma | Mature T-cell Malignancies | Relapsed/ Refractory T-cell MalignanciesUnited States
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National Cancer Institute (NCI)CompletedPeripheral T-Cell Lymphoma (PTCL) | T-Cell Prolymphocytic Leukemia | Cutaneous T Cell Lymphoma (CTCL) | T-Cell Lymphoma Relapsed | Adult T-Cell Leukemia (ATL)United States
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University of WashingtonNational Cancer Institute (NCI)TerminatedCutaneous T-cell Lymphoma Stage I | Cutaneous T-cell Lymphoma Stage II | Cutaneous T-cell Lymphoma Stage III | Cutaneous T-cell Lymphoma Stage IVUnited States
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SciTech Development, LLCRush University Medical CenterRecruitingMycosis Fungoides | Cutaneous T-cell Lymphoma | Peripheral T-cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | T-cell Lymphoma | Cutaneous/Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Classified | Primary Cutaneous T-cell Lymphoma | Cutaneous T-Cell Lymphoma, Unspecified | Follicular... and other conditionsUnited States
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John ReneauActive, not recruitingRecurrent T-Cell Non-Hodgkin Lymphoma | Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Stage III Cutaneous T-Cell Non-Hodgkin Lymphoma | Stage IV Cutaneous T-Cell Non-Hodgkin Lymphoma | Primary Cutaneous Anaplastic Large Cell Lymphoma | Refractory Primary Cutaneous T-Cell Non-Hodgkin... and other conditionsUnited States
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Dana-Farber Cancer InstituteRecruitingCutaneous T Cell Lymphoma | Peripheral T Cell LymphomaUnited States
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National Cancer Institute (NCI)CompletedLymphoma | Cutaneous | T-CellUnited States
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