NCT06232694Recruiting
Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML
Clinical Study Protocol of Idarubicin, Cytarabine, and Venetoclax -Induced Remission Followed by Consolidation Therapy With Medium-dose Cytarabine Combined With Venetoclax in Newly Diagnosed Adult Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 31 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 22 Jan 2024
- Start date
- 1 Jan 2024
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06232694
What you commit to
- Study type: Interventional
- Planned participants: 54
- From 1 Jan 2024 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 standards.Participants with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Non-active carriers of viral hepatitis or participants with low viral hepatitis viral titers after receiving non-prohibited antiviral therapy will not be excluded.
- Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment.
- Participants who have previously received venetoclax treatment and/or are currently participating in any other study involving investigational drugs.
Other illness
- 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, or angina with ordinary physical activity.
- 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).
Other
- Acute promyelocytic leukemia (APL).
- Relapsed/refractory AML patients.
- AML patients with known involvement of the central nervous system (CNS).
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.