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New treatment option for Acute Myeloid Leukemia
Official title VAC Regimen for AML Patients Who Failed to Response to VA Regimen
ClinicalTrials.gov ID: NCT06220162
What this study is testing
What is chidamide in combination with venetoclax and azacitidine (VAC)?
chidamide in combination with venetoclax and azacitidine (VAC) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid 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
- Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.
- 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 to 80
You may be able to join if
- Patients with AML who are not suitable for intensive chemotherapy according to the WHO diagnosis: age ≥60 years or age \<60 years but fulfil the...
- Age 18 to 59 years;
- Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3;
- Expected survival time ≥3 months;
- Or fulfilment of severe cardiac, pulmonary, hepatic, or renal disease; (A) Presence of a cardiac history of congestive heart failure, or ejection...
You likely can't join if
- Patients with a history of myeloproliferative neoplasms (MPN), including myelofibrosis, thrombocythemia, polycythaemia vera, chronic granulocytic...
- Patients with FLT3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued);
- Patients with less than 50% reduction of blasts after VA regimen;
- Patients with active CNS involvement;
- With prior treatment with chidamide;
- Clinically uncontrolled active infections (including bacterial, fungal or viral infections) and organ hemorrhage;
See the full eligibility criteria
- Patients with AML who are not suitable for intensive chemotherapy according to the WHO diagnosis: age ≥60 years or age \<60 years but fulfil the following criteria;
- Age 18 to 59 years;
- Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3;
- Expected survival time ≥3 months;
- Or fulfilment of severe cardiac, pulmonary, hepatic, or renal disease; (A) Presence of a cardiac history of congestive heart failure, or ejection fraction ≤ 50%, or presence of chronic stable angina; (B) Lung carbon...
- Not received radiotherapy, treatment regimens other than the VA regimen, or haematopoietic stem cell transplantation within 4 weeks prior to enrolment;
- Other comorbidities that, in the judgement of the physician, make the administration of intensive chemotherapy unsuitable;
- Ability to understand and willingness to sign the informed consent for this trial;
- The patient refuses intensive chemotherapy and has the willingness to accept non-intensive chemotherapy.
- Patients with a history of myeloproliferative neoplasms (MPN), including myelofibrosis, thrombocythemia, polycythaemia vera, chronic granulocytic leukemia (CML) with or without BCR-ABL1 translocation, and AML or acute...
- Patients with FLT3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued);
- Patients with less than 50% reduction of blasts after VA regimen;
- Patients with active CNS involvement;
- With prior treatment with chidamide;
- Clinically uncontrolled active infections (including bacterial, fungal or viral infections) and organ hemorrhage;
- Pregnant or lactating women;
- Participation in any other clinical trial within 3 months prior to VAC regimen;
- With other malignant tumours;
- With uncontrolled mental disorders;
- Any other condition that, in the opinion of the investigator, makes it inappropriate to participate in this trial.
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 to 80 years. 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.