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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
Enrollment
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Inclusion criteria
(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
The subject's previous history of anti-tumor therapy meets one of the following conditions:
Hypersensitivity to any study drug or its components;
Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.);
Cardiac function and disease meet one of the following conditions:
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);
Human immunodeficiency virus (HIV) infection (HIV antibody positive);
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);
Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;
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.);
Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
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. -
Primary purpose
Allocation
Interventional model
Masking
45 participants in 1 patient group
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Central trial contact
Wenbin Qian; Xibin Xiao
Data sourced from clinicaltrials.gov
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