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New treatment option for Acute Myeloid Leukemia
Official title Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML
ClinicalTrials.gov ID: NCT06232694
What this study is testing
What is Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;?
Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration; is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Idarubicin (Idarubicin): 10-12mg/m2 on days 1 to 3; intravenous infusion, ;Cytarabine (Cytarabine): 100mg/m2 on days 1 to 7; intravenous infusion or subcutaneous injection..
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 evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML). This study includes the induction and consolidation phases of AML treatment.
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 60
You may be able to join if
- Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification.
- Age between 18 and 60 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2).
- Cardiac ultrasound LVEF ≥ 45%.
- Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample).
You likely can't join if
- Acute promyelocytic leukemia (APL).
- Relapsed/refractory AML patients.
- AML patients with known involvement of the central nervous system (CNS).
- Known HIV-infected participants (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be conducted...
- Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment.
- Participants with New York Heart Association (NYHA) functional classification \> Grade 2. Grade 2 is defined as patients having cardiac disease with...
See the full eligibility criteria
- Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification.
- Age between 18 and 60 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2).
- Cardiac ultrasound LVEF ≥ 45%.
- Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample).
- Liver function: Aspartate aminotransferase (AST) ≤ 2.5 × ULN\ ; Alanine aminotransferase (ALT) ≤ 2.5 × ULN\ ; Total bilirubin ≤ 1.5 × ULN\ (\ unless considered due to leukemia infiltration).
- Signed informed consent form.
- Acute promyelocytic leukemia (APL).
- Relapsed/refractory AML patients.
- AML patients with known involvement of the central nervous system (CNS).
- Known HIV-infected participants (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be conducted during screening according to local guidelines or institutional...
- Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment.
- Participants with New York Heart Association (NYHA) functional classification \> Grade 2. Grade 2 is defined as patients having cardiac disease with no symptoms at rest but experiencing fatigue, palpitations, dyspnea...
- Participants with chronic respiratory disease requiring continuous oxygen therapy.
- Patients unable to take oral medications or with malabsorption syndrome.
- Presence of uncontrolled systemic infection (viral, bacterial, or fungal).
- Participants who have previously received venetoclax treatment and/or are currently participating in any other study involving investigational drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, 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 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, 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.