A Single-arm, Multicenter, Prospective Clinical Study of Mitoxantrone Liposome Combined With Chidamide and Azacitidine in the Treatment of Relapsed and Refractory Peripheral T-cell Lymphoma

NCT05495100 | Unknown Phase 2

• 1 other identifier: 2022-0453
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with chidamide and azacitidine in the treatment of relapsed and refractory peripheral T-cell lymphoma

Conditions

Peripheral T Cell Lymphoma

Keywords

Relapsed and refractory peripheral T-cell lymphoma; mitoxantrone liposomes

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  one year

Study Arms (1)

Mitoxantrone liposome combined with Chidamide and Azacitidine

EXPERIMENTAL

Drug: Mitoxantrone liposome、Chidamide、Azacitidine

Interventions

Mitoxantrone liposome、Chidamide、Azacitidine DRUG

Mitoxantrone liposome 20mg/m2, d1; Chidamide 20mg, biw; Azacitidine 100mg, d1\~7; Every 4 weeks is a cycle, with a maximum of 4 cycles of treatment.

Mitoxantrone liposome combined with Chidamide and Azacitidine

Eligibility Criteria

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

You may qualify if:

• Patients fully understand this study, voluntarily participate in and sign an informed consent form (ICF);
• Age: 18\~75 years old;
• Expected survival time ≥ 3 months;
• Histopathologically confirmed PTCL, one of the following subtypes:
• (1) Peripheral T-cell lymphoma unspecified (PTCL-NOS) (2) Angioimmunoblastic T-cell lymphoma (AITL) (3) Anaplastic large T-cell lymphoma (ALCL), ALK+ (4) Anaplastic large T-cell lymphoma (ALCL), ALK- (5) Other subtypes of PTCL that the researchers believe can be enrolled; 5. Relapsed/refractory patients who have received at least first-line systemic therapy with anthracycline-containing regimens in the past. Relapse was defined as relapse after CR or progression after PR; refractory was defined as previous systemic chemotherapy treatment, 2 cycles of response evaluation as PD, or 4 cycles of response evaluation as SD; 6. There must be at least one evaluable or measurable lesion that meets the Lugano2014 criteria: lymph node lesions, measurable lymph nodes should be \>1.5cm in length; non-lymph node lesions, measurable extranodal lesions should be \>1.0cm in length; 7. ECOG score 0-2 points; 8. Bone marrow function: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥80g/L (the neutrophil count in patients with bone marrow involvement can be relaxed to ≥1.0×109/L, Platelet count can be relaxed to ≥50×109/L, and hemoglobin can be relaxed to ≥75 g/L); Liver and kidney function: Serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤2.5 times the upper limit of normal (for patients with liver involvement ≤5 times the upper limit of normal); total bilirubin ≤1.5 times the upper limit of normal (for liver involvement patients ≤ 3 times the upper limit of normal);

You may not qualify if:

• The subject's previous history of anti-tumor therapy meets one of the following conditions:
• Those who have received mitoxantrone or mitoxantrone liposome in the past;
• Have received doxorubicin or other anthracycline therapy in the past, and the total cumulative dose of doxorubicin is more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin converted from other anthracyclines);
• Patients who have received autologous hematopoietic stem cell transplantation within 100 days of the first medication, or have received allogeneic hematopoietic stem cell transplantation;
• Received anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the study drug;
• Hypersensitivity to any study drug or its components;
• Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.);
• Cardiac function and disease meet one of the following conditions:
• Long QTc syndrome or QTc interval \>480 ms;
• Complete left bundle branch block, second or third degree atrioventricular block;
• severe, uncontrolled arrhythmia requiring medical treatment;
• New York College of Cardiology classification ≥ grade III;
• Cardiac ejection fraction (LVEF) less than 50%;
• History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other arrhythmia requiring treatment, clinically significant pericardial disease within 6 months prior to recruitment, or acute ischemic or active ECG evidence of conduction system abnormalities.
• Active infection of hepatitis B and C (HBV surface antigen positive and hepatitis B virus DNA more than 1x103 copies/mL; hepatitis C virus RNA more than 1x103 copies/mL);

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Ningbo No. 1 Hospital: collaborator
• Jinhua Central Hospital: collaborator
• Huizhou Municipal Central Hospital: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Zhejiang, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenbin Qian

  13605801032

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xibin Xiao

CONTACT

13858015535; xiaoxibinzju@zju.edu.cn

Wenbin Qian

CONTACT

13605801032

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 10, 2022
• Study Start: August 11, 2022
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2024
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

CN (1)