Mitoxantrone Hydrochloride Liposomes in Combination With GDP in Relapsed/Refractory PTCL

This is an interventional treatment trial for Treatment Read More

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. Expected survival ≥ 3 months;
4. Histologically confirmed diagnosis of peripheral T-cell lymphoma, is one of the following subtypes (1) Peripheral T-cell lymphoma non-specific type (PTCL-NOS) (2) Angioimmunoblastic T-cell lymphoma (AITL) (3) Anaplastic large cell lymphoma (ALCL), ALK+ (4) Anaplastic large cell lymphoma (ALCL), ALK- (5) Other subtypes of PTCL that the researcher considered to be included in the group;
5. The criteria for relapsed/refractory lymphoma: Relapsed lymphoma is defined as lymphoma that relapsed after a complete response (CR) was achieved with initial chemotherapy. Refractory lymphoma is diagnosed by meeting any of the following criteria: 1) tumor reduction < 50% or disease progression after 4 cycles of standard regimens of chemotherapy; 2) CR was achieved by standard chemotherapy, but relapse occurred within six months; 3) Two or more times of recurrence after CR; 4) Relapse after hematopoietic stem cell transplantation;
6. 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;
7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2；
8. Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥75×109/L, Hemoglobin(HB)≥ 80g/L(Bone marrow invasive patient ANC≥1.0×109/L,PLT≥50×109/L,HB≥75 g/L)
9. Liver and kidney function：Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) , The liver invasion≤3.0×ULN）;Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN , The liver invasion≤5.0×ULN; Serum creatinine (Scr) ≤1.5× ULN

Exclusion Criteria:

1. The subject had previously received any of the following anti-tumor treatments:

   1. Those who have previously received mitoxantrone or mitoxantrone liposomes;
   2. Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin is more than 550 mg/m2 (1 mg doxorubicin converted from other anthracycline drugs is equivalent to 2 mg epirubicin);
   3. Have received anti-tumor treatment (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 drugs;
   4. 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. Non controlled systemic diseases (such as active infection, non controlled hypertension, diabetes, etc.)

4. Heart function and disease meet one of the following conditions:

   1. Long QT c syndrome or QTc interval > 480 ms;
   2. Complete left bundle branch block, grade II or III atrioventricular block;
   3. Serious and uncontrolled arrhythmias requiring drug treatment;
   4. New York Heart Association grade ≥ III;
   5. Cardiac ejection fraction (LVEF)< 50%;
   6. 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.
   7. Baseline NT-proBNP is greater than 800pg/ mL, cTnI is greater than the normal upper limit of our center, and the retest in three days which is still higher than the above range.
5. Hepatitis B, Hepatitis C infection in active stage (if there is a positive hepatitis B surface antigen or core antibody, additional test HBV DNA, Hepatitis B virus DNA more than 1x103 copies /mL excluded; If HCV anti-body is positive, add test for HCV RNA, and exclude HCV RNA over 1x103 copies /mL)
6. Past or current co-occurrence of other malignancies (except effectively controlled non-melanoma cutaneous basal cell carcinoma, breast/cervical carcinoma in situ, and other malignancies effectively controlled without treatment within the past five years)
7. Have primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;
8. Pregnant and lactating women and patients of childbearing age who do not want to use contraception;
9. Conditions that other researchers deem inappropriate to participate in this study.