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

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

NCT ID: NCT05527275

Condition: Relapsed and Refractory Peripheral T-cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Mitoxantrone

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Mitoxantrone liposome combine with Chidamide
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.
Arm group label: Mitoxantrone Hydrochloride Liposome Injection Combined With Chidamide

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

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

Address:
City: Guangzhou
Zip: 510060
Country: China

Start date: October 1, 2022

Completion date: December 1, 2024

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05527275