Last updated: November 5, 2023
Sponsor: Zhejiang University
Overall Status: Active - Recruiting
Phase
1
Condition
Lymphoproliferative Disorders
Leukemia
Platelet Disorders
Treatment
Blinatumomab
Clinical Study ID
NCT06125106
IIT20230044C-R1
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosed as acute B-ALL with CD19+ according to the 2022 WHO classification criteria.After induction and intensified chemotherapy, complete hematological remission wasachieved, 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 trialand agreed to take effective contraceptive measures during the trial until their lastvisit;
- Organ function is normal, and the following laboratory indicators are met within oneweek of enrollment: creatinine clearance rate ≥ 60 mL/min (according to the CockcroftFault formula); AST and ALT ≤ 3 × Upper limit of normal value range (ULN), totalbilirubin ≤ 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 therequirements of the study.
Exclusion
Exclusion Criteria:
- Failure to achieve complete hematological remission, including residual extramedullaryinfiltration;
- 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 nervoussystem leukemia;
- Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc;
- Currently suffering from clinically significant active cardiovascular diseases, suchas uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, anygrade 3 or 4 heart disease determined according to the New York Heart Association (NYHA) functional classification (see Appendix 1), or having a history of myocardialinfarction 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 hepatitisB 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 aninformed consent form.
Study Design
Total Participants: 31
Treatment Group(s): 1
Primary Treatment: Blinatumomab
Phase: 1
Study Start date:
November 16, 2023
Estimated Completion Date:
February 01, 2026
Study Description
Connect with a study center
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting
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