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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05495100
Collaborator
Ningbo No. 1 Hospital (Other), Jinhua Central Hospital (Other), Huizhou Municipal Central Hospital (Other)
45
1
1
24
1.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Mitoxantrone liposome、Chidamide、Azacitidine
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 11, 2022
Anticipated Primary Completion Date :
Aug 11, 2023
Anticipated Study Completion Date :
Aug 11, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mitoxantrone liposome combined with Chidamide and Azacitidine

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.

Outcome Measures

Primary Outcome Measures

  1. ORR [one year]

    objective response rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

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

  3. 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);

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

  5. 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;

  6. Hypersensitivity to any study drug or its components;

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

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

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

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

  11. severe, uncontrolled arrhythmia requiring medical treatment;

  12. New York College of Cardiology classification ≥ grade III;

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

  14. 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.

  15. 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);

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

  17. 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);

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

  19. 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.);

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

  21. 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. -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Second Affiliated Hospital, School of Medicine, Zhejiang University Zhejiang Zhejiang China

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Wenbin Qian, 13605801032

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05495100
Other Study ID Numbers:
  • 2022-0453
First Posted:
Aug 10, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022