Actively Recruiting
RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
Led by He Huang · Updated on 2024-08-26
118
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Elderly patients with acute myeloid leukemia (AML) often face unfavorable prognostic factors such as multiple comorbidities, adverse cytogenetic profiles, and pre-existing hematological disorders. The long-term survival rate remains very low, with a 5-year survival rate of only 5% to 10%. The introduction of the BCL-2 inhibitor venetoclax (Ven) has improved the induction remission rates in elderly patients. However, the question of whether to use chemotherapy maintenance or proceed with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for post-remission consolidation therapy remains unclear due to the lack of prospective controlled studies. Therefore, our center plans to conduct a prospective, open-label, two-arm, non-randomized, single-center study to further explore the optimal consolidation treatment strategy for elderly AML patients at intermediate and high risk following induction complete remission (CR).
CONDITIONS
Official Title
RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with AML according to the 2022 WHO diagnostic criteria
- Age 60 to 75 years
- Intermediate to high-risk AML according to ELN criteria, AML with myelodysplasia-related changes, therapy-related AML, or core-binding factor AML with D816 KIT mutation
- Newly diagnosed hypercellular leukemia with white blood cell count 10��������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������
You will not qualify if you...
- Clinically active cardiovascular disease including uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, NYHA class 3 or 4 heart disease, or myocardial infarction within 3 months before screening
- Severe diseases limiting participation such as severe infection or renal failure
- Known HIV infection or severe viral hepatitis not controlled by medication
- Pregnant or breastfeeding women
- Unable to understand or comply with the study protocol or sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
Y
Yanmin Zhao, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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