Study design and patient selection
thrombosis, cardiac block, bleeding, mental illness, allergic, myocardial infarction, liver dysfunction, AML, aGVHD, embolism, coronary artery heart, active infection, renal dysfunction
THROMBOSIS, CEREBRAL HEMORRHAGE, BLEEDING, MYOCARDIAL INFARCTION, HEART DISEASE, VENTRICULAR TACHYCARDIA, ATRIAL FIBRILLATION, ACUTE GVHD, AML, CONGESTIVE HEART FAILURE, CAVITY, ONCOLOGY, EMBOLISM
This is a phase II, single-arm clinical trial registered at Chinese PLA General Hospital and with ChiCTR.org identifier ChiCTR1800017740. The trial was approved by the Ethics Committee of Chinese PLA General Hospital and conducted according to the Declaration of Helsinki. Its primary objective was to assess the efficacy and safety of CCAG plus DLI regimen. The study was open for patient accrual from September 2018 to April 2022. Eligible patients were ≥ 18 years old and had relapsed AML or MDS after allo-HSCT, Eastern Cooperative Oncology Group performance status ≤ 3, and expected survival time ≥ 4 months. The exclusion criteria included (1) Patients who were allergic or had contraindications to the drugs; (2) Patients at pregnant or lactation period; (3) Patients with active infection; (4) Patients who smoked or indulged in excessive drinking, affected the outcome of the trial; (5) Patients with mental illness or other conditions could not get informed consent, cooperate with treatment and physical examination; (6) Patients with active bleeding; (7) In the past year, patients had thrombosis, embolism, cerebral hemorrhage, and so on; (8) Patients received surgical treatment, and the operation period was less than 6 weeks; (9) Patients with clinically significant QTC interval prolongation (time of male is more than 450 ms, time of female is more than 470 ms), ventricular tachycardia, atrial fibrillation, and above two degree cardiac block. Patients with myocardial infarction within 1 years, congestive heart failure, coronary artery heart with symptom and needed to be treated. Patients with heart disease, the ultrasound showed that the area of the pericardial cavity was more than 10 mm in the end diastole; (10) Patients with liver dysfunction, total bilirubin > 1.5 times normal upper limit, alanine aminotransferase/aspartate aminotransferase > 2.5 times normal upper limit. Patients with liver involvement, alanine aminotransferase/aspartate aminotransferase > 5 times normal upper limit. Patients with renal dysfunction, peripheral blood creatinine > 1.5 times normal upper limit; (11) Patients with grade II–IV acute GVHD (aGVHD); (12) The researchers decided that participants were not suitable to participate in the clinical trial. All participants gave written informed consent.