Actively Recruiting
Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-08-06
31
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia
CONDITIONS
Official Title
Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 65 years, any gender
- Newly diagnosed B-ALL with CD19 positive leukemic cells
- Philadelphia chromosome-negative B-ALL with high-risk features post allo-HSCT
- At least 2 months post-transplant with blood cell recovery
- Bone marrow in remission and minimal residual disease negative before enrollment
- ECOG performance status less than 3 and Karnofsky score 70 or higher
- No history of grade III or IV graft-versus-host disease and no active GVHD at enrollment
- Adequate liver, kidney, and heart function as defined by study limits
- Expected survival longer than 3 months
- Able and willing to provide written informed consent and follow study requirements
You will not qualify if you...
- History of severe allergic reactions to the study drug or similar compounds
- Pregnant or breastfeeding women, or women not willing to use contraception
- Severe heart problems including low ejection fraction, arrhythmias, prolonged QTc, recent heart attack, or symptomatic coronary artery disease
- Severe lung problems with obstructive or restrictive impairment
- Severe liver damage with high liver enzymes or bilirubin
- Severe kidney damage with high creatinine or low creatinine clearance
- Active infection or uncontrolled bleeding
- History of blood clots, embolism, brain bleeding, or major vascular events within the past year
- Psychiatric illness or other conditions affecting consent or study compliance
- Major organ surgery within the last 6 weeks
- Drug abuse or chronic alcoholism impacting study assessments
- Previous organ transplant other than hematopoietic stem cell transplantation
- Any other condition that makes participation unsafe or unsuitable according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Zhejiang University
Hangzhou, China
Actively Recruiting
Research Team
Y
Yi Luo, MD
CONTACT
L
Luxin Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here