Actively Recruiting
Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL
Led by Sheng-Li Xue, MD · Updated on 2025-11-21
42
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Sheng-Li Xue, MD
Lead Sponsor
J
Jining Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
As part of postremission consolidative therapy, the decision to proceed with hematopoietic stem cell transplantation is a recommendable regimen in ALL therapy. However, The recurrence rate is high after transplantation. Minimal Residual Disease (MRD) is an important factor affecting the effect of HSCT. The hematologic recurrence rate of MRD-positive patients with adult ALL is high. MRD- is associated with better prognosis. Therefore, maintaining MRD- after transplantation is necessary for long-term survival. The purpose of this study is to explore the efficacy and safety of Inotuzumab Ozogamicin in the treatment of minimal residual disease recurrence after HSCT of ALL patients.
CONDITIONS
Official Title
Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 15 to 65 years
- Diagnosed with CD22-positive B-cell acute lymphoblastic leukemia according to 2023 NCCN standards
- CD22-positive B-ALL patients with minimal residual disease recurrence after hematopoietic stem cell transplantation
- Philadelphia chromosome-positive ALL patients who failed treatment with one or more second-generation BCR::ABL1 tyrosine kinase inhibitors
- ECOG performance status score less than 3
- Expected survival time of at least 3 months
- No serious heart, lung, liver, or kidney disease
- Ability to understand and voluntarily provide informed consent
You will not qualify if you...
- Allergy to Inotuzumab Ozogamicin or similar drugs
- Pregnancy or breastfeeding, or unwillingness to use effective contraception if of childbearing potential
- Active infection
- Active bleeding
- New thrombosis, embolism, cerebral hemorrhage, or related medical history within one year before enrollment
- Mental disorders or conditions preventing informed consent or study participation
- Liver function abnormalities exceeding specified limits or kidney function anomalies
- History of significant heart rhythm problems, heart attack within one year, heart failure, or symptomatic coronary heart disease requiring treatment
- Surgery on major organs within the past six weeks
- Drug or long-term alcohol abuse affecting study evaluation
- Prior organ transplants except bone marrow transplantation
- Deemed unsuitable for the study by the investigator
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
S
Sheng-Li Xue, MD
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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