A Phase I/II Study of Mitoxantrone Liposome Combined With Chidamide in Relapsed/Refractory Peripheral T-cell Lymphoma

NCT ID: NCT05527275

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-12-01

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.

Conditions

Relapsed and Refractory Peripheral T-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mitoxantrone Hydrochloride Liposome Injection Combined With Chidamide

Group Type: EXPERIMENTAL

Mitoxantrone liposome combine with Chidamide

Intervention Type: DRUG

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.

Interventions

Mitoxantrone liposome combine with Chidamide

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhiming

Sun Yat-sen University Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Medical Oncology,Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Li Zhiming, M.D.

Role: CONTACT

Lizhm@sysucc.org.cn

020-87343292

Li Zhiming, M.D.

Role: CONTACT

Lizhm@sysucc.org.cn

02087343292

Other Identifiers

2022-FXY-140-内科

Identifier Type: -

Identifier Source: org_study_id