Status:
RECRUITING
Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing Blinatumomab
Lead Sponsor:
Zhejiang University
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
A study on the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab
Detailed Description
This is a prospective multicenter clinical study. This study is applicable to CD19+ ALL patients undergoing allogeneic hematopoietic stem cell transplantation. The purpose is to evaluate the effective...
Eligibility Criteria
Inclusion
- Diagnosed as acute B-ALL with CD19+ according to the 2022 WHO classification criteria. After induction and intensified chemotherapy, complete hematological remission was achieved, but MRD was positive by flow cytometry;
- Age range from 18 to 70 years old, regardless of gender;
- The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2 points;
- Female patients of childbearing age who had a negative pregnancy test before the trial and agreed to take effective contraceptive measures during the trial until their last visit;
- Organ function is normal, and the following laboratory indicators are met within one week of enrollment: creatinine clearance rate ≥ 60 mL/min (according to the Cockcroft Fault formula); AST and ALT ≤ 3 × Upper limit of normal value range (ULN), total bilirubin ≤ 2 × ULN; Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%;
- Life expectancy greater than 8 weeks;
- Voluntarily sign an informed consent form to understand and comply with the requirements of the study.
Exclusion
- Failure to achieve complete hematological remission, including residual extramedullary infiltration;
- Previously received hematopoietic stem cell transplantation;
- Received systemic chemotherapy within 2 weeks;
- Previously received treatment with Blinatumomab;
- Have a history of central nervous system leukemia or present with central nervous system leukemia;
- Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc;
- Currently suffering from clinically significant active cardiovascular diseases, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease determined according to the New York Heart Association (NYHA) functional classification (see Appendix 1), or having a history of myocardial infarction within 6 months prior to screening;
- Chronic obstructive pulmonary disease with whole lung dysfunction;
- Other serious diseases that may restrict patients from participating in this test (such as advanced infection, uncontrollable diabetes);
- Concomitant arteriovenous thrombosis or hypercoagulable state;
- Known human immunodeficiency virus (HIV) infection, or chronic infection of hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive) beyond drug control;
- Pregnant or lactating women;
- Severe allergies to other monoclonal antibodies in the past;
- Those who are unable to understand, comply with the research protocol or sign an informed consent form.
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06125106
Start Date
November 16 2023
End Date
February 1 2026
Last Update
November 9 2023
Active Locations (1)
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1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310000