Phase
Condition
Leukemia
Acute Myeloid Leukemia
Platelet Disorders
Treatment
MEC Regimen
CAV Regimen
Clinical Study ID
Ages 16-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 16-65 years old.
Diagnosed with R/R AML.
Patients with AML must meet one of the following criteria, A or B: A: Refractory AMLdisease was defined as follows: (1) failure to attain CR following exposure to atleast 2 courses of standard or intensive induction therapy; or (2) bone marrowleukemia cell decline index (BMCDI) < 50% and > 20% after 1 course of standard orintensive induction therapy. B: Relapsed AML disease was defined as follows:
(1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.
- ECOG performance status score less than 2. 5. Expected survival time ≥12 weeks. 6.Without serious heart, lung, liver, or kidney dysfunction. 7. Able to understand andprovide informed consent.
Exclusion
Exclusion Criteria:
Patients who are allergic to the study drug or drugs with similar chemicalstructures.
Pregnant or lactating women, and women of childbearing age who do not want topractice effective methods of contraception.
Active infection.
Active bleeding.
Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or amedical history within one year before enrollment.
Patients with mental disorders or other conditions.
Liver function abnormalities (total bilirubin > 1.5 times of the upper limit of thenormal range, ALT/AST > 2.5 times of the upper limit of the normal range or patientswith liver involvement whose ALT/AST > 1.5 times the upper limit of the normalrange), or renal dysfunction (Ccr<50ml/h).
Patients with a history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation,II-degree heart block, myocardial infarction attack within one year beforeenrollment, and congestive heart failure, and patients with coronary heart diseasewho have clinical symptoms and requiring drug treatment.
Patients who relapsed after allogeneic hematopoietic stem cell transplantation.
Drug abuse or long-term alcohol abuse that would affect the evaluation results.
Patients who have received organ transplants.
Patients not suitable for the study according to the investigator's assessment.
Study Design
Study Description
Connect with a study center
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
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