Status:
NOT_YET_RECRUITING
Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults AML and MDS
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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
Detailed Description
Multiple clinical trials about chemotherapy plus venetoclax in primary diagnosed AML or relapsed/refractly AML were ongoing to attempt the facility of the combination. Zu et al demostrated that full d...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- younger than 18 years old, or older than 60 years old.
- Diagnosed as acute promyelocytic leukaemia.
- Pretreated with anthracycline.
- CNS involvement.
- 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),
- Inability to sign the informed consent form.
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 2 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06050941
Start Date
April 2 2024
End Date
April 2 2027
Last Update
March 5 2024
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