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New treatment option for AML
Official title Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML
ClinicalTrials.gov ID: NCT06611839
What this study is testing
What is Ivosidenib, Venetoclax, Azacitidine?
Ivosidenib, Venetoclax, Azacitidine is an investigational medicine, being studied as a potential treatment for aml.
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
- Venetoclax can bind to the BCL-2 protein, thereby initiating the apoptosis program and exerting anti-AML effects. The induction regimen combining venetoclax with hypomethylating agents (HMA) significantly improves the remission rate (over 60%) in elderly unfit AML patients and markedly prolongs survival in those achieving complete remission.
- 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 14 and older
You may be able to join if
- Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards with IDH1 mutations detected by PCR or second-generation...
- Age ≥14 years old, male or female.
- The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
- Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :
- Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);
You likely can't join if
- people who meet any of the following criteria are excluded from the study:
- Acute promyelocytic leukemia with PML-RARA fusion gene
- Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
- Acute myeloid leukemia with BCR-ABL fusion gene
- Treated patients (but can receive hydroxyurea or cytarabine to lower tumor burden).
- Concurrent malignant tumors of other organs (those requiring treatment).
See the full eligibility criteria
- Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards with IDH1 mutations detected by PCR or second-generation sequencing.
- Age ≥14 years old, male or female.
- The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
- Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :
- Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);
- AST and ALT≤ 2.5 times the upper limit of normal value (same age);
- Blood creatinine \< 2 times the upper limit of normal (same age);
- Myocardial enzymes \< 2 times the upper limit of normal (same age);
- Left ventricular ejection fraction \>50% by measure of echocardiogram (ECHO) Informed consent must be signed before the commencement of all specific study procedures, and is signed by the patient himself or his...
- people who meet any of the following criteria are excluded from the study:
- Acute promyelocytic leukemia with PML-RARA fusion gene
- Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
- Acute myeloid leukemia with BCR-ABL fusion gene
- Treated patients (but can receive hydroxyurea or cytarabine to lower tumor burden).
- Concurrent malignant tumors of other organs (those requiring treatment).
- Active heart disease, defined as one or more of the following:
- A history of uncontrolled or symptomatic angina;
- Myocardial infarction less than 6 months after enrollment;
- Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;
- Uncontrolled or symptomatic congestive heart failure (\> NYHA level 2);
- Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).
- Those who were not considered suitable for inclusion by the researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.