Clinical trial NCT05527275: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Relapsed and Refractory Peripheral T-cell Lymphoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: RP2D
timeFrame: 24 months
measure: ORR
timeFrame: 24 months
Secondary outcomes:
measure: MTD
timeFrame: 24 months
measure: DLT
timeFrame: 24 months
measure: DOR
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Medical Oncology,Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
References: