Relapsed or Refractory Acute Myeloid Leukemia
Conditions
Interventions
Experimental group:hartaxidine and cytarabine combined with mitoxantrone liposome
Sponsors
Tianjin Medical University General 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 (including boundary values 18 and 75); 3. Relapsed refractory AML other than acute promyelocytic leukemia (APL) diagnosed by clinical diagnosis; (1)Relapsed AML: after complete remission (CR), leukemia cells in peripheral blood or primordial cells in bone marrow > 5% (except for bone marrow regeneration after consolidation chemotherapy) or leukemia cell infiltration outside the bone marrow; (2)Relapsed/refractory AML (one of the following is sufficient): 1)Untreated cases that were ineffective after 2 courses of standard regimen; 2)Relapse within 12 months after consolidation and intensive therapy after CR; 3)Relapse after 12 months but ineffective after conventional chemotherapy; 4)>= 2 recurrences; e)Persistence of extramedullary leukemia; 4. Eastern Oncology Collaboration (ECOG) Physical status score: 0-2; 5. Expected survival >= 3 months; 6. Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x upper limit of normal (ULN) (<= 5 x ULN for patients with liver infiltrates); Total bilirubin <=1.5 x ULN (<= 3 x ULN for patients with liver infiltration); Serum creatinine <=1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. The subject had previously received any of the following anti-tumor treatments: Those who have previously received mitoxantrone or mitoxantrone liposomes; Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin is more than 360 mg/m2 (1 mg doxorubicin converted from other anthracycline drugs is equivalent to 2 mg daunorubicin or 0.5 mg idarubicin); 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 5 weeks or 21 days before the first use of the study drugs; 2. Heart function and disease meet one of the following conditions: Long QTc syndrome or QTc interval > 480 ms; Complete left bundle branch block, grade II or III atrioventricular block; Serious and uncontrolled arrhythmias requiring drug treatment; New York Heart Association grade II; Cardiac ejection fraction (LVEF)< 50%; 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. 3. Treatment-related or secondary (transformation of hematological diseases such as early MDS/MPN) AML; 4. Central nervous system leukemia; 5.Other malignancies, except for effectively controlled non melanoma skin basal cell carcinoma, breast / cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment in the past five years; 6. Non-controlled systemic diseases (such as active infection, non controlled hypertension, diabetes, etc.); 7. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 8. Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA over 1x103 copy/mL; hepatitis C virus RNA over 1x103 copy/mL); 9. Hypersensitivity to any study drug or its components; 10. Pregnant women, lactating women, patients who refused to take effective contraceptive measures during the study; 11. Serious neurological or psychiatric history; 12. Unsuitable subjects for this study determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete response rate (CRc); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Time to response (TTR);Disease free survival (DFS);Overall survival (OS);Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0); | — |
Countries
China
Contacts
Public ContactRong Fu
Tianjin Medical University General Hospital
Outcome results
None listed