Acute myeloid leukemia
Conditions
Interventions
Case series:Cladribine Combined with Low-Dose Cytarabine and Azacitidine Sequential Regimen
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 60 to 80 years old; 2. Diagnosed as acute myeloid leukemia by routine examination of bone marrow and immunophenotyping; 3. Patients did not receive any systemic treatment for acute myeloid leukemia before enrolling in the trial; 4. Patients must sign the informed consent form before taking any test related to the trial. Patients should be aware that he/she has the right to withdraw from the trial at any time without affecting subsequent treatment; 6. Main organs have no serious organic lesions (except for renal insufficiency caused by the disease), and the following laboratory trial indicator requirements shall be met (within 7 days before treatment): 1) Total bilirubin <=1.5 times of upper limit of normal (same age group); 2) AST and ALT <=2.5 times of upper limit of normal (same age group); 3) Myocardial enzyme < 2 times of upper limit of normal (same age group); 4) Cardiac ejection fraction measured by echocardiography (ECHO) is within the normal range.
Exclusion criteria
Exclusion criteria: 1. Previously or currently complicated with primary lesion or tumor that does not meet acute myeloid leukemia histologically; 2. Congestive heart failure > New York Heart Association (NYHA) level II; 3. Active coronary artery disease (patients with myocardial infarction 6 months before enrollment can be enrolled); 4. Arrhythmia requiring antiarrhythmic treatment (except for receptor blockers, calcium antagonists or digoxin); 5. Uncontrollable hypertension (even after treatment with 3 antihypertensive drugs, diastolic blood pressure still cannot be controlled below 90mmHg); 6. Renal failure requiring hemodialysis or peritoneal dialysis; 7. Patients with serious thrombotic event before treatment; 8. Long-term use of warfarin for atrial fibrillation or other reasons; 9. Undergoing major surgery within 30 days prior to enrollment; 10. E-COG score > 3 points; 11. Patients with known human immunodeficiency virus (HIV) infection; 12. History of malignancy other than acute myeloid leukemia, unless the patient's disease is cured for more than 3 years; 13. Severe infectious diseases (unhealed tuberculosis, pulmonary aspergillosis); 14. Epilepsy, dementia, and other abnormal mental conditions requiring medication and not understanding or following the research protocol; 15. Patients with clinically significant gastrointestinal bleeding within 30 days before enrollment; 16. History of allogeneic organ transplantation; 17. Substance abuse and medical, psychological or social conditions which may interfere with patient participation in the study or assessment of the results of the study; 18. Patients with known or suspected allergy to the trial drug or allergy to any drug associated with the trial; 19. Previous or current combined treatments and drugs that need to be excluded; 20. Receiving any systemic anti-tumor treatment for acute myeloid leukemia before enrollment into the trial, such as chemotherapy, immunotherapy and hormone therapy (except for hormonal supportive therapy); 21. Previous use of trial drug therapy for acute myeloid leukemia; 22. Unsuitable for enrollment as considered by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactXiujin Ye
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed