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New treatment option for Leukemia, Myeloid, Acute
Official title Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML
ClinicalTrials.gov ID: NCT05305859
What this study is testing
What is venetoclax combining chidamide and azacitidine (VCA)?
venetoclax combining chidamide and azacitidine (VCA) is an investigational medicine, being studied as a potential treatment for leukemia, myeloid, acute.
Also referred to as VCA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- Diagnosis of acute promyelocytic leukemia (APL)
- Central nervous system leukemia
- Uncontrolled or significant cardiovascular disease, including any of the following:
- Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family...
- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular...
- History of second (Mobitz II) or third degree heart block (people with pacemakers are eligible if they have no history of fainting or clinically...
See the full eligibility 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:
- Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L
- ALT and AST ≤ 3 × upper limit of normal (ULN)
- Able to understand and sign an informed consent form (ICF).
- Diagnosis of acute promyelocytic leukemia (APL)
- Central nervous system leukemia
- Uncontrolled or significant cardiovascular disease, including any of the following:
- 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);
- 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);
- History of second (Mobitz II) or third degree heart block (people with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
- History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
- History of New York Heart Association Class 3 or 4 heart failure;
- Complete left bundle branch block;
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.