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

NCT ID: NCT05495100

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-11
• Study Completion Date: 2024-08-11

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mitoxantrone liposome combined with Chidamide and Azacitidine

Group Type: EXPERIMENTAL

Mitoxantrone liposome、Chidamide、Azacitidine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo No. 1 Hospital

OTHER

Sponsor Role: collaborator

Jinhua Central Hospital

OTHER

Sponsor Role: collaborator

Huizhou Municipal Central Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenbin Qian

Role: PRINCIPAL_INVESTIGATOR

13605801032

Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University

Zhejiang, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xibin Xiao

Role: CONTACT

xiaoxibinzju@zju.edu.cn

13858015535

Wenbin Qian

Role: CONTACT

13605801032

Facility Contacts

Xibin Xiao

Role: primary

xiaoxibinzju@zju.edu.cn

13858015535

Other Identifiers

2022-0453

Identifier Type: -

Identifier Source: org_study_id