venetoclax combining chidamide and azacitidine (VCA)
venetoclax combining chidamide and azacitidine (VCA): information already included in arm/group descriptions
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Complete remission (CR) rate — 2 months CR was \<5% marrow blasts by morphology
Overall response rate (ORR) — 2 months ORR is defined as CR, CRi and PR.
Trial sites (1)
Facility
City
Region
Status
Bing Xu
Xiamen
Fujian
Recruiting
More The First Affiliated Hospital of Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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