Actively Recruiting
Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-08-09
78
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective of the study is to evaluate the efficacy and safety of maintenance therapy with hypomethylating agent and Venetoclax to improve leukemia free survival for high-risk myeloid malignancies after allogeneic hematopoietic stem cell transplantation .
CONDITIONS
Official Title
Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with AML or MDS who have received allogeneic hematopoietic cell transplantation
- Patients with AML must have one or more high-risk features including adverse risk cytogenetics or molecular markers, requiring more than 2 courses of induction chemotherapy to reach remission, extramedullary disease, second or later remission, or measurable residual disease at transplant
- Patients with MDS must have high or very high-risk IPSS-R scores, TP53 mutation, or measurable residual disease at transplant
- Blood counts with ANC ≥ 1.0 × 10e9/L, hemoglobin ≥ 80 g/L, and platelets ≥ 50 × 10e9/L
- ECOG performance status of 0, 1, or 2
You will not qualify if you...
- Concurrent use of targeted drugs
- Resistance to venetoclax before transplantation
- Allergy to decitabine, azacitidine, or venetoclax
- Active grade II or higher acute graft-versus-host disease (GVHD)
- Active moderate or severe chronic GVHD
- Disease recurrence indicated by abnormal myeloid cells, low donor cell percentage (<90%), or graft rejection
- Blood counts with ANC < 1.0 × 10e9/L or platelets < 50 × 10e9/L
- Severe organ dysfunction including elevated liver enzymes or bilirubin, creatinine clearance < 50 mL/min, or elevated serum creatinine
- Active uncontrolled systemic infections (fungal, bacterial, or viral)
- Pregnant or breastfeeding women
- Other severe complications deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Jiao Tong University School of Medicine Affilated Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
X
Xueying Ding, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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