Clinical Study of Mitoxantrone Hydrochloride Liposome Injection vs. Chidamide in Patients With Relapsed/Refractory PTCL

NCT04668690 | Active Not Recruiting Phase 3

• 1 other identifier: HE071-CSP-013
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, active controlled, multi-center, phase 3 clinical study to compare the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection with Chidamide in patients with relapsed/refractory Peripheral T Cell Lymphoma (PTCL).

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• PFS assessed by the IRC

  PFS (progression-free survival) assessed by the Independent Review Committee (IRC)

  Up to 48 months

Secondary Outcomes (8)

• PFS assessed by investigators

  Up to 48 months

• ORR

  Up to 48 months

• TTR

  Up to 48 months

• DoR

  Up to 48 months

• DoRR

  Up to 48 months

Study Arms (2)

Experimental: Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

Patients with relapsed/refractory PTCL will receive Mitoxantrone Hydrochloride Liposome Injection every 28 days (a cycle) for a maximum of 8 cycles. The dose of Mitoxantrone Hydrochloride Liposome Injection is 20 mg/m2.

Drug: Mitoxantrone Hydrochloride Liposome Injection

Active Comparator: Chidamide

ACTIVE COMPARATOR

Patients with relapsed/refractory PTCL will receive Chidamide 30 mg p.o., twice per week until disease progression.

Drug: Chidamide

Interventions

Mitoxantrone Hydrochloride Liposome Injection DRUG

Drug: Liposomal mitoxantrone hydrochloride (20 mg/m2) administered as an intravenous infusion on day 1 of each 28-day cycle.

Also known as: HE071, Liposomal Mitoxantrone Hydrochloride Injection

Experimental: Mitoxantrone Hydrochloride Liposome Injection

Chidamide DRUG

Drug: Chidamide tablet (30 mg) is given to the patients p.o. 30 minutes after breakfast, twice per week with 3-day intervals.

Active Comparator: Chidamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects fully understand and voluntarily participate in this study and sign informed consent;
• Age ≥18, ≤75 years, no gender limitation;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2;
• Histopathologically confirmed Peripheral T -cell Lymphoma (PTCL) according to World Health Organization (WHO) criteria (version 2016), with the subtypes as follows:
• Peripheral T-cell lymphoma, unspecified (PTCL, NOS);
• Angioimmunoblastic T-cell lymphoma (AITL);
• ALK+ systematic anaplastic large T-cell lymphoma (ALCL, ALK+);
• ALK-systematic anaplastic large T-cell lymphoma (ALCL，ALK-);
• Extranobal NK/T cell lymphoma (nasal type) (NKTCL);
• Other subtypes of PTCL which are appropriate to be enrolled in the opinion of the investigator.
• Patients have relapsed or are refractory to at least one line of prior systemic therapy (anthracycline-containing regimen) for PTCL. Relapse is defined as recurrence after CR or progress after PR; refractory refers to the efficacy of 2 cycles of treatment is PD, or the efficacy of 4 cycles of treatment is SD;
• Subjects have at least one measurable lesion in accordance with the Lugano evaluation criteria (version 2014): the long axis of the lymph node shall be\>1.5 cm, the long axis of the extranodal lesions shall be\>1.0 cm.
• Subjects must provide a written pathology/histological diagnosis report during the screening period and must agree to provide a tumor tissue section or tumor/lymph node tissue specimen to be sent to the central laboratory.
• Life expectancy ≥ 12 weeks;
• During the screening period, the patients should meet the following requirements and have not received infusion of cell growth factor, platelet and granulocyte within 7 days of the hematology test; 1) Absolute value of neutrophils ≥ 1.5 × 109/L; absolute value of neutrophil ≥ 1.0 × 109/L in patients with involvement of bone marrow; 2) Hemoglobin ≥ 90 g/L (no red cell infusion within 14 days), hemoglobin ≥ 75 g/L in patients with involvement of bone marrow; 3) Platelet ≥ 75 × 109/L in patients without involvement of bone marrow; platelet ≥ 50 × 109/L in patients with involvement of bone marrow; 4) Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin ≤ 3 × ULN if bilirubin level increase is caused by lymphoma invading the liver); 5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; if the elevated level of AST or ALT is caused by liver involvement, both AST and ALT shall be ≤ 5 × ULN); 6) Creatinine \< 1.5 × ULN.

You may not qualify if:

• Patients with leukemia type PTCL (adult T-cell leukemia/lymphoma, etc.), or in lymphoma leukemia stage (malignant cell proportion of \> 20% in bone marrow examination); or with central nervous system (CNS) involvement, or with complicated of hemophagocytic syndrome.
• History of allergy and contraindications to the same class and excipients of the experimental drug.;
• Patients have one of the following conditions in the previous anti-tumor treatments:1) Patients received mitoxantrone or liposome mitoxantrone within 6 months;2) Patients who was treated with Chidamide and the efficacy was evaluated as PD; Patients who was treated with Chidamide within 6 months (if the patients have been treated with Chidamide for no more than 2 weeks, had no clear evidence of PD and no intolerable toxicity during the treatment period, and discontinued therapy for other reasons, may be considered with the investigator's consent);3) Those receiving treatment of Adriamycin or other anthracyclines previously, with the total cumulative dose of \> 360 mg/m2 (other anthracycline drugs: 1 mg of epirubicin/pyramycin/daunorubicin is equivalent to 0.5 mg of doxorubicin, 1 mg of deoxydaunorubicin is equivalent to 2 mg of doxorubicin);4) Those received anti-tumor treatment, including cytotoxic chemotherapy, radiotherapy and targeted drug therapy within 4 weeks prior to the first use of the study drug, or immunomodulators (thalidomide, lenalidomide) within 3 weeks; or hormone or herbal therapy with lymphoma as indication within 2 weeks;
• Participated in other clinical studies and received therapy within 4 weeks prior to the first administration of the study drug;
• Those received allogeneic hematopoietic stem cell transplantation previously and autologous hematopoietic stem cell transplantation within 6 months;
• Adverse reactions from the previous anti-tumor treatment have not yet recovered (\>Grade 1 in NCI-CTCAE \[Version 4.03\], with the exception of hair loss and pigmentation);
• Subjects with the impaired cardiac function or significant heart disease, including but not limited to:1) Myocardial infarction, congestive heart failure and viral myocarditis occurred 6 months before screening; heart disease with symptoms requiring treatment and intervention, such as unstable angina, arrhythmia, etc.;2) Congestive heart failure of ≥Grade 2 according to the New York Heart Association Classification;3) Cardiac ejection fraction less than 50% or less than the lower limit of the reference range of the laboratory examination used in the Research Center;4) Persistent myocardial disease;5) QTc \> 450 milliseconds, or congenital long QT syndrome.
• Patients with active infection, including hepatitis B (positive hepatitis B virus surface antigen and HBV-DNA titer higher than the upper limit of the reference range) and hepatitis C (positive hepatitis C virus RNA and HCV-RNA titer higher than the upper limit of the reference range);
• History of severe autoimmune disease and immunodeficiency, including positive for human immunodeficiency virus (HIV); or other acquired or congenital immune deficiency diseases; or a history of organ transplantation;
• Patients with other malignant tumors in the past five years (except the cured non-melanoma skin basal cell carcinoma and cervical carcinoma in situ);
• Major surgery within 6 weeks prior to screening. or have a surgical schedule during the study period;
• Patients have significant gastrointestinal disorders that may affect the ingestion, transportation, or absorption of the drug (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.) during the screening period;
• Patients have uncontrolled hypertension (systolic pressure of 180 mmHg and/or diastolic pressure of 110 mmHg after treatment); or type 2 diabetes that cannot be controlled by oral hypoglycemic drugs or insulin therapy;
• The patients had a history of active bleeding within the previous 3 months before the screening;
• History of mental illness or history of drug abuse or dependence;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 16, 2020
• Study Start: April 13, 2021
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

CN (1)