peripheral T cell lymphoma
Conditions
Interventions
Dose-finding stage:Liposomal mitoxantrone hydrochloride (12 mg/m2, 15 mg/m2, 18 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.
Dose-expansion stage: Liposomal mitoxantrone hydrochloride(RP2D dose) will be administered by an intravenous infusion on day 1 of each 28-day cycle
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand and voluntarily participate in this study and sign informed consent; 2. Aged 18 to 70 years; 3. Histologically confirmed diagnosis of PTCL: Peripheral T-cell lymphoma – not otherwise specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma (AITL), ALK -positive Anaplastic Large cell Lymphoma (ALCL), ALK-negative ALCL; Other PTCL that investigators consider to be appropriate to be enrolled; 4. PTCL with fluorodeoxyglucose (FDG) avidity that can be evaluated by PET/CT; 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1; 6. The following required baseline laboratory data: Absolute neutrophil count (ANC) >=1.5x10^9/L, Platelet count (PLT) >=75x10^9/L, Hemoglobin(HB)>=80g/L, Total bilirubin (TBIL) <=1.5 ULN, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 ULN, Serum creatinine (Scr) <=1.5 ULN; 7. Females of childbearing potential must have a negative serum beta human chorionic gonadotrophin (beta-hCG) pregnancy test result prior to enrollment and must agree to use an effective contraception method for the duration of the study treatment and 12 months after the last dose of study therapy; 8. Males of reproductive potential must agree to use an effective contraceptive method for the duration of the study treatment and 12 months after the last dose of study therapy.
Exclusion criteria
Exclusion criteria: 1. Current diagnosis of any of the following: extranodal natural killer/T-cell lymphoma, nasal type(NKTCL), Mycosis fungoides (MF)/ Sézary syndrome (SS), Primary cutaneous ALCLand Adult T-cell leukemia/lymphoma. 2. Leukemic phase of lymphoma (>=20% lymphoma cell in the bone marrow), or central nervous system (CNS) involvement, or hemophagocytic syndrome; 3. Life expectancy < 6 months 4. History of allergy to anthracyclines or liposomes; 5. History of contraindications to cyclophosphamide, vincristine or prednisone; 6. Prior anti-lymphoma therapy except short-term or low-dose corticosteroid treatment; 7. Impaired cardiac function or significant cardiac disease; 8. Positive test results for HBsAg antigen and HBV-DNA, or hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody; 9. Major surgery within 46weeks prior to screening. Or have a surgical schedule during the study; 10. A serious infection within 4 weeks prior to screening and not suitable for the study according to the judgment of the investigator; 11. Uncontrolled hypertension at screening; 12. Uncontrolled diabetes at screening; 13. History of active visceral hemorrhage in the recent 3 months prior to screening; 14. History of other tumors in the past five years prior to screening. Patients with curable tumors (such as skin basal cell carcinoma, carcinoma in situ of the cervix or of the breast, intramucosal carcinoma in situ of the gastrointestinal tract or localized prostate cancer) could be enrolled after completely cured; 15. History of solid organ transplantation; 16. Known psychiatric disorders or cognitive disorder; 17. Known alcohol or drug abuse; 18. Pregnant or breastfeeding women; 19. Not suitable for this study as determined by the investigator due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response(CR) rate;duration of complete response(DoCR);overall response rate (ORR);progression-free survival(PFS); | — |
Countries
China
Contacts
Public ContactXuefang Xia
CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang)Co., Ltd.
Outcome results
None listed