Relapsed/refractory peripheral T-cell lymphoma
Conditions
Interventions
research group:mitoxantrone hydrochloride liposome injection combined with azacitidine and tislelizumab
Sponsors
Tongji Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients or their legal guardians voluntarily participate and sign the informed consent; 2. Male or female patients aged 18 to 70 (including 18 and 70 years old); 3. PTCL confirmed by histopathology and/or cytology, the subtypes are as follows: (1) Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS); (2) Peripheral T-cell lymphoma with follicular helper cell (TFH) phenotype (PTCL), including angioimmunoblastic T-cell lymphoma (AITL), follicular helper T-cell lymphoma, and extranodal peripheral T-cell lymphoma with a follicular helper T-cell phenotype; (3) ALK+ systemic anaplastic large T-cell lymphoma; (4) ALK- systemic anaplastic large T-cell lymphoma (ALCL, ALK-); Based on the subtype data of previous mitoxantrone liposome monotherapy for relapsed/refractory PTCL, this study tends to enroll patients with angioimmunoblastic T-cell lymphoma (AITL); 4. Meet the criteria for relapsed/refractory lymphoma: Relapsed lymphoma refers to lymphoma that relapses after obtaining a complete remission (CR) after initial chemotherapy. Refractory lymphoma refers to the diagnosis that meets any of the following: (1) After 4 courses of standard chemotherapy, the tumor shrinks 1.5cm in length; non-lymph node lesions, measurable extranodal lesions should be > 1.0cm in length; 6. Patients Main tissues and organs function well: (1) Liver function: ALT/AST = 50%; 7. Patients with ECOG score = 3 months; 9. Bone marrow function: neutrophil count >= 1.5 x 10^9/L, platelet count >= 75 x 10^9 /L, hemoglobin >= 80 g/L (neutrophil count can be relaxed to >= 1.0 x 10^9 in patients with bone marrow involvement /L, platelet count can be relaxed to >= 50 x 10^9 /L, hemoglobin can be relaxed to >= 75 g/L); 10. Women of childbearing age must have a pregnancy test (serum or urine) within 14 days before enrollment, and the results negative and willing to use a reliable method of contraception during the trial.
Exclusion criteria
Exclusion criteria: 1. Extranodal NK/T cell lymphoma and primary or metastatic central nervous system lymphoma; 2. The subject's previous anti-tumor treatment history meets one of the following conditions: (1) Previously received mitoxantrone or mitoxantrone liposome; (2) Previously received PD-1 or PD-L1 inhibitor; (3) Patients with angioimmunoblastic T-cell lymphoma who have previously received azacitidine therapy; (4) Previously received doxorubicin or other anthracycline therapy, and the total cumulative dose of doxorubicin > 360mg/m2 ( For other anthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin, or 2 mg of pirarubicin, or 2 mg of daunorubicin, or 0.5 mg of demethoxydaunorubicin); (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 receiving clinical trial drugs; (6) Those who have received allogeneic hematopoietic stem cell transplantation before and received autologous hematopoietic stem cell transplantation within 6 months; 3. Cardiac function and disease meet one of the following conditions: (1) Electrocardiogram (ECG) during the screening period (ECG) examination, male: QTc>450 ms, female: QTc>470 ms; (2) Clinically significant arrhythmias, including but not limited to complete left bundle branch abnormalities, second-degree atrioventricular block, PR interval > 250 milliseconds; (3) Any risk factor that increases QTc interval prolongation, such as hypokalemia, hereditary long QT syndrome, currently taking QT interval prolonging drugs or discontinued for less than 15 days; (4) New York Heart Disease, USA Congestive heart failure with society grade >= 2; (5) Cardiac ejection fraction is less than 50% or lower than the lower limit of the laboratory test value range of the research center; (6) Myocardial infarction, unstable angina pectoris, history of severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities; (7) Baseline B-type pro-brain natriuretic peptide (NT-proBNP) is greater than 1800pg/L, troponin I (cTnI) is greater than the upper limit of normal in our center, and the retest is still higher than the above range after three days; 5. Patients suffering from uncontrollable infectious diseases or systemic use of hormones within 4 weeks before enrollment (except for patients using inhaled hormones); 6. HBV DNA, hepatitis B virus DNA exceeding 1 x 10^3 copies/mL is excluded; if hepatitis C antibody is positive, additional HCV RNA, hepatitis C virus RNA exceeding 1 x 10^3 copies/mL is excluded); 7. HIV-infected patients and patients with severe autoimmune diseases or immune; 8. Patients with known history of immediate or delayed hypersensitivity reactions to study drugs and similar drugs; 9. Patients with abnormal coagulation function and bleeding tendency; 10. There is clinically significant abnormal thyroid function, and use Patients whose thyroid hormone levels cannot be maintained within the normal range by drugs; 11. Patients with mental illness and drug abuse/addiction; 12. According to the investigator's judgment, the patient has other conditions that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Remission (TTR);best treatment response;safety; | — |
Countries
China
Contacts
Public ContactHuang Liang
Tongji Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology
Outcome results
None listed