NCT06050941Not yet recruitingPhase 2
Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults AML and MDS
A Multi-center Prospective Single Arm Clinical Study of Reduced Intensive 3 + 5 Idarubicin and Cytarabine Chemotherapy Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndrome
Source: ClinicalTrials.gov · Last updated 5 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Reduced intensive 3 + 5 idarubicin and cytarabine chemotherapy plus venetoclax as first-line treatment for adults with acute myeloid leukaemia and high-risk myelodysplastic syndrome
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Apr 2023
- Start date
- 2 Apr 2024
- Primary completion date
- 2 Apr 2026
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- NCT number
- NCT06050941
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 2 Apr 2024 to the primary completion date, 2 Apr 2026
- No sites listed in no 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pretreated with anthracycline.
Other illness
- Positive for HIV, hepatitis B virus, or hepatitis C virus.
- New York Heart Association cardiovascular disability status higher than grade 2 (grade 2 is defined as cardiac disorder that is asymptomatic at rest, but ordinary physical activity might result in fatigue, palpitations, dyspnoea, or angina), chronic respiratory diseases requiring continuous supplementary oxygen, inability to take oral medication or malabsorption syndrome
- Uncontrollable systemic infection (viral, bacterial, or fungal),
Age
- younger than 18 years old, or older than 60 years old.
Other
- Diagnosed as acute promyelocytic leukaemia.
- CNS involvement.
- Inability to sign the informed consent form.
Who the study is looking for
- aged 18-60 years
- had a confirmed diagnosis of previously untreated de novo acute myeloid leukaemia or high risk myelodysplastic syndrome by bone marrow examination according to the criteria presented by WHO.
- Eastern Cooperative Oncology Group performance status of 0-2.
- adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.