Leukemia, Myeloid, Acute Clinical Trial
Official title:
A Multi-center, Prospective, Single-arm Study of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of Refractory/Relapsed Acute Myelogenous Leukemia (R/R AML)
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AML
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 31, 2026 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 - Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology - ECOG:0-2 - Life expectancy = 3 months - Adequate laboratory parameters during the screening period as evidenced by the following: 1. Creatinine clearance=30 mL/min and serum Creatinine = 160µmol/L 2. ALT and AST = 3 × upper limit of normal (ULN) 3. Able to understand and sign an informed consent form (ICF). Exclusion Criteria: - Diagnosis of acute promyelocytic leukemia (APL) - Central nervous system leukemia - Uncontrolled or significant cardiovascular disease, including any of the following: 1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome); 2. Systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes); 3. History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker); 4. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening; 5. History of New York Heart Association Class 3 or 4 heart failure; 6. Complete left bundle branch block; 7. Known history of left ventricular ejection fraction (LVEF) =45% or less than the institutional lower limit of normal; - Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy; - Suffered from other non-myeloid malignancies within 2 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease - Females who are pregnant or breastfeeding; - Mental disorders that hinder research participation - Previous solid organ transplantation (SCT treatment is allowed in advance, but if the patient has GVHD or is still receiving immunosuppression/GVHD treatment, it is not allowed) - Any other situation where the investigator believes that the patient should not participate in this trial |
Country | Name | City | State |
---|---|---|---|
China | Bing Xu | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Xiamen University | Dongguan People's Hospital, Fujian Cancer Hospital, Fujian Provincial Hospital, Huizhou Municipal Central Hospital, Jieyang People's Hospital, Zhangzhou manicipal hospital of Fujian Province |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete remission (CR) rate | CR was <5% marrow blasts by morphology | 2 months | |
Secondary | 1 year leukemia free survival (LFS) | Leukemia-free survival (LFS) is defined as survival without evidence of relapse from treatment initiation | 1 year from treatment initiation | |
Secondary | 1year overall survival (OS) | Overall survival(OS)is defined as the time from treatment initiation to death from any cause. | 1 year from treatment initiation | |
Secondary | Adverse events | Adverse event is defined as any untoward medical occurrence associated with treatment | 2 months | |
Secondary | objective response rate (ORR) | ORR is defined as CR, CRi and PR. Partial remission (PR) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate and the normalization of blood counts. | 2 months |
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