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New treatment option for Acute Monocytic Leukemia
Official title Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia
ClinicalTrials.gov ID: NCT05566054
What this study is testing
What is Chidamide?
Chidamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute monocytic leukemia.
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
- This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy
- 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
- Confirmation of acute monocytic leukemia( AML-M5) diagnosis by the French-American-British (FAB) Classification and/or characterized for expression...
- \>= 60 years of age
- \>=18 to 59years of age with at least one of the following comorbidities: Any other comorbidity that the physician judges to be incompatible with...
- Must meet the laboratory requirements per the protocol.
- Female participant must not be pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for...
You likely can't join if
- Patients who are allergic to the study drug or drugs with similar chemical structures
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception
- Active infection
- Active bleeding
- Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment
- Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and...
See the full eligibility criteria
- Confirmation of acute monocytic leukemia( AML-M5) diagnosis by the French-American-British (FAB) Classification and/or characterized for expression of monocytic and myeloid differentiation markers, have a projected life...
- \>= 60 years of age
- \>=18 to 59years of age with at least one of the following comorbidities: Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy: (A)Eastern Cooperative Oncology Group (ECOG)...
- Must meet the laboratory requirements per the protocol.
- Female participant must not be pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 90 days after the last dose of study drug.
- Female participants of childbearing potential must agree to use at least 1 protocol-specified method of birth control and male participants, if sexually active with female partner(s) of childbearing potential, must...
- Did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before enrollment;
- Other comorbidities that are not suitable for intensive chemotherapy;
- The patient refused to receive intensive chemotherapy;
- Ability to understand and willing to sign the informed consent for this trial.
- Patients who are allergic to the study drug or drugs with similar chemical structures
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception
- Active infection
- Active bleeding
- Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment
- Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met
- Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the...
- 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...
- Urgery on the main organs within the past six weeks
- Drug abuse or long-term alcohol abuse that would affect the evaluation results
- Patients who have received organ transplants (excepting bone marrow transplantation)
- Patients not suitable for the study according to the investigator's assessment
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, 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 Suzhou, Jiangsu, 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.