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Trial Title:
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
Condition:
Peripheral T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Azacitidine
Mitoxantrone
Conditions: Keywords:
Relapsed and refractory peripheral T-cell lymphoma
mitoxantrone liposomes
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mitoxantrone liposome、Chidamide、Azacitidine
Description:
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.
Arm group label:
Mitoxantrone liposome combined with Chidamide and Azacitidine
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
Criteria for 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. -
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Zhejiang
Country:
China
Status:
Recruiting
Contact:
Last name:
Xibin Xiao
Phone:
13858015535
Email:
xiaoxibinzju@zju.edu.cn
Start date:
August 11, 2022
Completion date:
August 11, 2024
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Ningbo No. 1 Hospital
Agency class:
Other
Collaborator:
Agency:
Jinhua Central Hospital
Agency class:
Other
Collaborator:
Agency:
Huizhou Municipal Central Hospital
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05495100
