Back to results

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

Primary Purpose

Relapsed Cutaneous T Cell Lymphom

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Mitoxantrone HCL Liposome Injection

About this trial

This is an interventional treatment trial for Relapsed Cutaneous T Cell Lymphom

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mitoxantrone HCL Liposome Injection

Arm Description

Each treatment cycle lasts for 28 days with 20mg/m2

Outcomes

Primary Outcome Measures

Objective response rate (ORR; complete response + partial response [CR + PR])

Secondary Outcome Measures

Duration of Response (DOR)

Time to Response (TTR)

Progression-free survival (PFS)

Pruritus remission rate

Full Information

NCT ID

NCT02597153

First Posted

November 3, 2015

Last Updated

May 23, 2017

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02597153

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

Just one subject enrolled in this trial during one and a half years.

Study Start Date

October 2015 (Actual)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed Cutaneous T Cell Lymphom

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mitoxantrone HCL Liposome Injection

Arm Type

Experimental

Arm Description

Each treatment cycle lasts for 28 days with 20mg/m2

Intervention Type

Drug

Intervention Name(s)

Mitoxantrone HCL Liposome Injection

Primary Outcome Measure Information:

Title

Objective response rate (ORR; complete response + partial response [CR + PR])

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

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)

Title

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)

Title

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

Title

Pruritus remission rate

Time Frame

Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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: 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.

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs