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Status unknownNCT05527275Updated Sep 2, 2022

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

A Phase 1/2 interventional study of Mitoxantrone liposome combine with Chidamide in Relapsed and Refractory Peripheral T-cell Lymphoma, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by Sun Yat-sen University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
78
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Relapsed and Refractory Peripheral T-cell Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 78 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    Mitoxantrone Hydrochloride Liposome Injection Combined With Chidamide

    Drug: Mitoxantrone liposome combine with Chidamide

Interventions

  • DrugMitoxantrone 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.

06

What researchers measure

Primary outcomes

  1. RP2D

    Phase II recommended dose

    Time frame: 24 months

  2. ORR

    Objective remission rate

    Time frame: 24 months

Secondary outcomes

  1. MTD

    Maximum tolerated dose

    Time frame: 24 months

  2. DLT

    Dose-limiting toxicity

    Time frame: 24 months

  3. DOR

    Duration of remission time

    Time frame: 24 months

07

Study locations

1 site
  • Department of Medical Oncology,Sun Yat-Sen University Cancer Center
    Guangzhou, Guangdong 510060, China
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05527275
Lead sponsor
Sun Yat-sen University
Responsible party
Li Zhiming (Sun Yat-sen University Cancer Center, Sun Yat-sen University) — Principal investigator
First posted
Sep 2, 2022
Start date
Oct 1, 2022 (estimated)
Primary completion
Sep 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Sep 2, 2022

Study contacts

Li Zhiming, M.D.
Contact
Lizhm@sysucc.org.cn
020-87343292
Li Zhiming, M.D.
Contact
Lizhm@sysucc.org.cn
02087343292

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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