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
Overview
- Phase
- Phase 1
- Intervention
- Blinatumomab
- Conditions
- Acute Lymphoblastic Leukemia
- Sponsor
- Zhejiang University
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Progress-Free Survival
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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 effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab.31 patients will be included in the study. Clinical endpoints include progress-free survival, Overall survival, cumulative incidence of relapse, non-relapse mortality, minimal residual disease, and graft versus host disease.
Investigators
He Huang
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Zhejiang University
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
Blinatumomab Group
Haploidentical hematopoietic stem cell transplantation was performed using a Conditioning regimen containing Blinatumomab. 28ug of Blinatumomab was administered intravenously once a day for a total of 7 days, followed by a routine conditioning regimen and haploid hematopoietic stem cell transplantation.
Intervention: Blinatumomab
Outcomes
Primary Outcomes
Progress-Free Survival
Time Frame: At Year 1
Progression-free survival (PFS) is defined as the time from transplantation to disease progression or death from any cause.
Secondary Outcomes
- chornic graft versus host disease(At Year 1)
- Overall Survival(At Year 1)
- Cumulative Incidence of Relapse(At Year 1)
- acute graft versus host disease(At Day 100)
- Minimal Residual Disease(At Year 1)
- Non-relapse Mortality(At Year 1)