lymphoma
Conditions
Interventions
Experimental group 1:Mitoxantrone hydrochloride liposome and Duvelisib
Experimental group 2:Mitoxantrone hydrochloride liposome and Duvelisib
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand and voluntarily participate in this study and sign informed consent 2. Age =18, =75 years, no gender limitation 3. Histologically confirmed diagnosis of peripheral T-cell lymphoma and Extranodal Natural Killer/T Cell lymphoma, is one of the following subtypes: a) Peripheral T-cell lymphoma non-specific type (PTCL-NOS) b) Angioimmunoblastic T-cell lymphoma (AITL) c) ALK+ systematic anaplastic large T-cell lymphoma (ALCL ALK+) d) ALK- systematic anaplastic large T-cell lymphoma (ALCL ALK-) e) Extranodal Natural Killer/T Cell lymphoma, nasal type (NKTCL) f) Enteropathy-associated T-cell lymphoma (EATCL) g) Primary hepatosplenic ?dT-cell lymphoma (HSTCL,?dT, Type I (traditional type), Type II) h) Primary cutaneous T cell lymphomas for which systemic therapy is indicated (PC-TCLs) i) Other aggressive T-cell-derived non-Hodgkin's lymphoma (except highly aggressive) that investigators consider to be appropriate to be enrolled 4. There must be at least one evaluable or measurable lesion meeting lugano2014 criteria: for lymph node lesions, the length and diameter should be >1.5cm; For non-lymph node lesions, the length and diameter should be >1.0cm 5.Those receivd at least first-line standard treatment (including chemotherapy, hematopoietic stem cell transplantation, asparaginase-containing regimen for NK/ T-cell lymphoma patients), patients were non-remission (or remission duration less than 30 days) or relapsed after remission; Anthracycline sensitivity (response with an anthracycline or anthracycline-containing chemotherapy regimen) is required if prior exposure to an anthracycline or anthracycline-containing chemotherapy regimen is required 6. Subjects must provide a written pathological/histological diagnosis report during the screening period, and agree to provide tumor tissue sections or fresh tumor tissue 7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 8. Expected survival = 3 months 9. Bone marrow function: Absolute neutrophil count (ANC) =1.5×10^9/L, Platelet count (PLT) =75×10^9/L, Hemoglobin (HB)= 80g/L (Bone marrow invasive patient ANC=1.0×10^9/L, PLT=50×10^9/L, HB=75 g/L), No red blood cell transfusions were received within 14 days prior to examination 10. Liver and kidney function: Serum creatinine =1.5 upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN, (The liver invasion=5×ULN); Total bilirubin (TBIL) =1.5×ULN, (The liver invasion=3×ULN); Creatinine clearance=30 mL/min according to Cockcroft-Gault. 11. Other adverse reactions during treatment: Cardiac adverse reactions, interstitial pneumonia must be restored to = grade 1 or baseline level (except hair loss, pigmentation). 12. Female subjects with negative blood or urine HCG (except menopause and hysterectomy), male and female subjects of childbearing age should take contraceptive measures during the test period and within 3 months after the last medication.
Exclusion criteria
Exclusion criteria: 1. Subjects are consistent with one of the following conditions in the previous anti-tumor treatment history: a) Those receiving Mitoxantrone or Mitoxantrone hydrochloride liposome previously b) Those receiving treatment of Adriamycin or other anthracyclines previously, with the total cumulative dose of Adriamycin >400 mg/m^2 (when converted to 1 mg Adriamycin, other anthracyclines shall be equivalent to 2 mg Epirubicin) c) Patients who have received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days of the first medication 2. Hypersensitivity to any study drug or its components 3. Previous treatment with a PI3K inhibitor 4. Chemotherapy and immunotherapy with other cytotoxic drugs were received within 3 weeks before treatment, and small molecule targeted therapy was received within 2 weeks before treatment. 5. Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A within 2 weeks before the first dose, or patients need to be treated with potent CYP3A inhibitors and inducers. 6. Participated in clinical trials within 4 weeks prior to study commencement 7. Those receiving major surgery within 4 weeks prior to the first dose or those who have not completely recovered from any previous invasive operation. 8. Human immunodeficiency virus (HIV) infection (HIV positive). 9. Hepatitis B, Hepatitis C infection in active stage (positive hepatitis B virus surface antigen and hepatitis B virus DNA of more than 1,000 copies/mL, Hepatitis C virus RNA of more than 1,000 copies/mL) 10. If there was active uncontrolled infection, oral treatment was required for infection control, and evaluated by the investigator 11. Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (subjects with detectable viral load) 12. Have serious and/or uncontrolled diseases (unstable angina pectoris, myocardial infarction, congestive heart-failure, severe unstable ventricular arrhythmia, a history of severe pericardial disease and other cardiovascular diseases; uncontrollable hypertension, diabetes, etc) 13. Heart function and disease meet one of the following conditions: a) Long QTc syndrome or QTc interval > 480 ms b) Complete left bundle branch block, grade II or III atrioventricular block c) Serious and uncontrolled arrhythmias requiring drug treatment d) New York Heart Association grade = II e) Cardiac ejection fraction (LVEF)< 50% f) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment. 14. Those with other malignant tumors previously or currently (except the non-melanoma skin basal cell carcinoma under effective control, breast/cervical carcinoma in situ, and other malignant tumors not treated but under effective control in the past five years) 15. Have primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment. 16. People with epilepsy who require medication 17. Severe lung disease; Severe heart disease; A history of mental illness, family history of psychosis, or mood disorder as evaluated by the researcher or psychologist. 18.Inability to swallow capsules, malabsorption syndrome, illness that significantly affects gastrointestinal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicities (DLT);Objective Response Rate (ORR);Recommended Phase II Dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress-free survival (PFS);Overall survival (OS);Complete remission rate (CR);Hematologic and non-hematologic toxicities (NCI CTCAE v5.0); | — |
Countries
China
Contacts
Public ContactZengjun Li
Shandong Cancer Hospital
Outcome results
None listed