Actively Recruiting
Decitabine, Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL
Led by The First Affiliated Hospital of Soochow University · Updated on 2024-11-19
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate whether maintenance therapy with decitabine, venetoclax and blinatumomab could improve the 2-year progression free survival (PFS) of patients with philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in measurable residual disease-negative remission.
CONDITIONS
Official Title
Decitabine, Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia patients who had an allogeneic stem cell transplant and meet one of these: in first complete remission with high-risk features, lack complete remission after standard induction chemotherapy, have detectable minimal residual disease before transplant, or in second or higher complete remission before transplant
- Negative minimal residual disease before enrollment (less than 0.01% by flow cytometry and fusion gene negative)
- At least 3 months post-transplantation
- Hematopoietic recovery with absolute neutrophil count ≥ 0.5 x 10^9/L and platelets > 20 x 10^9/L
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Total serum bilirubin ≤ 3 times upper limit of normal, alanine aminotransferase (ALT) ≤ 5 times upper limit of normal, aspartate aminotransferase (AST) ≤ 5 times upper limit of normal
- Creatinine clearance ≥ 30 mL/min
- Able and willing to provide informed consent
You will not qualify if you...
- Having another malignant disease
- Having uncontrolled active infection
- Left ventricular ejection fraction less than 0.5 or severe cardiovascular dysfunction (grade III/IV)
- Detectable minimal residual disease after transplant
- Active graft-versus-host disease needing systemic steroid treatment
- Uncontrolled active bleeding
- Pregnant or breastfeeding women; patients of childbearing potential must agree to use contraception during the study
- Other medical conditions deemed unsuitable for participation by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
X
Xiaowen Tang, Ph.D
CONTACT
D
Depei Wu, 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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