Back to resultsA Phase I/II Study of Mitoxantrone Liposome Combined With Chidamide in Relapsed/Refractory Peripheral T-cell Lymphoma
Primary Purpose
Relapsed and Refractory Peripheral T-cell Lymphoma
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Mitoxantrone liposome combine with Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed and Refractory Peripheral T-cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Patients participated voluntarily and signed informed consent；
- PTCL confirmed by histopathology；
- There must be at least one evaluable or measurable lesion that meets Lugano2014 criteria；
- The ECOG score is 0 to 1；
- ANC≥1.5×10*9/L，PLT≥75 × 10*9/L；HB≥80 g/L；TBIL≤1.5ULN；ALT or AST≤2.5 ULN； Scr≤1.5ULN；
- Use contraception during treatment and for one year after the end of treatment.
Exclusion Criteria:
- Patients with central nervous system (CNS) involvement and/or hemophagocytic syndrome；
- The estimated survival time is less than 6 months；
- History of allergy to anthracyclines or liposomes; Previous recipients of mitoxantrone or mitoxantrone liposome;Previous treatment with doxorubicin or other anthracyclines had a cumulative dose of doxorubicin > 360 mg/m2（For other anthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin, and the maximum cumulative dose of liposomal doxorubicin is 2460mg/m2）；
- The use of Chidamide is contraindicated;
- Impaired heart function or significant heart disease;
- Hepatitis B, hepatitis C active stage infection;
- Had undergone major surgery within 4 to 6 weeks prior or expected to undergo major surgery during the study;
- severe infection;
- Poorly controlled high blood pressure or diabetes;
- A history of active visceral bleeding within the previous 3 months
- A history of malignancy within five years;
- History of mental illness;
- A history of substance abuse or dependence;
- pregnant or lactating woman;
- The investigators did not consider it appropriate to participate in this study.
Sites / Locations
- Department of Medical Oncology,Sun Yat-Sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mitoxantrone Hydrochloride Liposome Injection Combined With Chidamide
Arm Description
Outcomes
Primary Outcome Measures
RP2D
Phase II recommended dose
ORR
Objective remission rate
Secondary Outcome Measures
MTD
Maximum tolerated dose
DLT
Dose-limiting toxicity
DOR
Duration of remission time
Full Information
NCT ID
NCT05527275
First Posted
August 30, 2022
Last Updated
September 1, 2022
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05527275
Brief Title
A Phase I/II Study of Mitoxantrone Liposome Combined With Chidamide in Relapsed/Refractory Peripheral T-cell Lymphoma
Official Title
A Multicenter, Single-arm, Prospective Phase I/II Trial of Mitoxantrone Hydrochloride Liposome Injection Combined With Chidamide in Relapsed or Refractory Peripheral T-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous group of aggressive non-Hodgkin lymphoma (NHL) originating from mature thymus T cells.Mitoxantrone Hydrochloride Liposome Injection can accelerate the entry of mitoxantrone into cells, reduce the efflux of mitoxantrone, ensure the concentration of intracellular drugs, reverse the drug resistance mechanism, and enhance anti-tumor activity.We will explore the dose-limiting toxicity (DLT) of Mitoxantrone Hydrochloride Liposome Injection combined with Chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma, estimate the maximum tolerated dose (MTD) of the combination, and determine the phase II recommended dose RP2D.In the phase II study, we will evaluate the safety and efficacy of the combination regimen.
Detailed Description
This study was a single-arm, open, multicenter phase I/II clinical study. An estimated 87 to 96 patients with relapsed or refractory PTCL will be enrolled. This program is divided into two parts:
The phase I study is expected to enroll 9 to 18 patients with relapsed or refractory PTCL who will be treated with Mitoxantrone Hydrochloride Liposome Injection combined with Chidamide.The phase II study is expected to enroll 78 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed and Refractory Peripheral T-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mitoxantrone Hydrochloride Liposome Injection Combined With Chidamide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone liposome combine with Chidamide
Intervention Description
Mitoxantrone Hydrochloride Liposome Injection： Grade 1: 14mg/ m2, D1; Grade 2: 17mg/ m2, D1; Grade 3: 20mg/ m2, D1; Chidamide：20mg twice a week (D1 and D4 or D2 and D5 or D3 and D6) Every 28 days for a cycle, a maximum of 6 cycles of treatment. Mitoxantrone Hydrochloride Liposome Injection RP2D was determined in the phase I trial, and the combination regimen will be used to in the phase II study, with a cycle of every 28 days and a maximum of 6 cycles of treatment.
Subsequently, maintenance treatment was performed: Chidamide, 20mg twice a week, for 1 year.
Primary Outcome Measure Information:
Title
RP2D
Description
Phase II recommended dose
Time Frame
24 months
Title
ORR
Description
Objective remission rate
Time Frame
24 months
Secondary Outcome Measure Information:
Title
MTD
Description
Maximum tolerated dose
Time Frame
24 months
Title
DLT
Description
Dose-limiting toxicity
Time Frame
24 months
Title
DOR
Description
Duration of remission time
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients participated voluntarily and signed informed consent；
PTCL confirmed by histopathology；
There must be at least one evaluable or measurable lesion that meets Lugano2014 criteria；
The ECOG score is 0 to 1；
ANC≥1.5×10*9/L，PLT≥75 × 10*9/L；HB≥80 g/L；TBIL≤1.5ULN；ALT or AST≤2.5 ULN； Scr≤1.5ULN；
Use contraception during treatment and for one year after the end of treatment.
Exclusion Criteria:
Patients with central nervous system (CNS) involvement and/or hemophagocytic syndrome；
The estimated survival time is less than 6 months；
History of allergy to anthracyclines or liposomes; Previous recipients of mitoxantrone or mitoxantrone liposome;Previous treatment with doxorubicin or other anthracyclines had a cumulative dose of doxorubicin > 360 mg/m2（For other anthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin, and the maximum cumulative dose of liposomal doxorubicin is 2460mg/m2）；
The use of Chidamide is contraindicated;
Impaired heart function or significant heart disease;
Hepatitis B, hepatitis C active stage infection;
Had undergone major surgery within 4 to 6 weeks prior or expected to undergo major surgery during the study;
severe infection;
Poorly controlled high blood pressure or diabetes;
A history of active visceral bleeding within the previous 3 months
A history of malignancy within five years;
History of mental illness;
A history of substance abuse or dependence;
pregnant or lactating woman;
The investigators did not consider it appropriate to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhiming, M.D.
Phone
020-87343292
Email
Lizhm@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhiming, M.D.
Phone
02087343292
Email
Lizhm@sysucc.org.cn
Facility Information:
Facility Name
Department of Medical Oncology,Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Phase I/II Study of Mitoxantrone Liposome Combined With Chidamide in Relapsed/Refractory Peripheral T-cell Lymphoma
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