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

Peripheral T Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495100
• Other study ID #: 2022-0453
• Status: Recruiting
• Phase: Phase 2
• Start date: August 11, 2022
• Est. completion date: August 11, 2024

Study information

• Verified date: August 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xibin Xiao
• Phone: 13858015535
• Email: xiaoxibinzju[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 11, 2024
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients fully understand this study, voluntarily participate in and sign an informed consent form (ICF);

2. Age: 18~75 years old;

3. Expected survival time = 3 months;

4. 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);

Exclusion Criteria:

1. The subject's previous history of anti-tumor therapy meets one of the following

conditions:

1. Those who have received mitoxantrone or mitoxantrone liposome in the past;

2. 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);

3. Patients who have received autologous hematopoietic stem cell transplantation within 100 days of the first medication, or have received allogeneic hematopoietic stem cell transplantation;

4. 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;

2. Hypersensitivity to any study drug or its components;

3. Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.);

4. Cardiac function and disease meet one of the following conditions:

1. Long QTc syndrome or QTc interval >480 ms;

2. Complete left bundle branch block, second or third degree atrioventricular block;

3. severe, uncontrolled arrhythmia requiring medical treatment;

4. New York College of Cardiology classification = grade III;

5. Cardiac ejection fraction (LVEF) less than 50%;

6. 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.

5. 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);

6. Human immunodeficiency virus (HIV) infection (HIV antibody positive);

7. Past or present with other malignant tumors (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment within the past five years);

8. Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;

9. There are obvious gastrointestinal diseases at the time of screening, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);

10. Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures;

11. Subjects with lymphoma and leukemia (proportion of malignant tumor cells in bone marrow examination> 20%) Circumstances judged by other investigators to be inappropriate to participate in this study. -

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

Intervention

Drug:
• Mitoxantrone liposome?Chidamide?Azacitidine
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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Zhejiang	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Huizhou Municipal Central Hospital, Jinhua Central Hospital, Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	objective response rate	one year