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Phase II Clinical Study of PLM60 for the Treatment of Cutaneous T Cell Lymphomas

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ClinicalTrials.gov Identifier: NCT02597153
Recruitment Status : Terminated (Just one subject enrolled in this trial during one and a half years.)
First Posted : November 5, 2015
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary:
To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with relapsed cutaneous T cell lymphomasell

Condition or disease Intervention/treatment Phase
Relapsed Cutaneous T Cell Lymphom Drug: Mitoxantrone HCL Liposome Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: Mitoxantrone HCL Liposome Injection
Each treatment cycle lasts for 28 days with 20mg/m2
Drug: Mitoxantrone HCL Liposome Injection



Primary Outcome Measures :
  1. Objective response rate (ORR; complete response + partial response [CR + PR]) [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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 ]
  4. 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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597153


Locations
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China
Beijing Cancer Hospital
Beijing, China
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02597153     History of Changes
Other Study ID Numbers: CSPC-HE154/PRO/Ⅱ
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Mitoxantrone
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action