Acute Lymphoblastic Leukemia
Conditions
Keywords
Minimal Residual Disease, Allogeneic hematopoietic stem cell transplantation, Blinatumomab
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.
Interventions
DRUGBlinatumomab
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.
Sponsors
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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; 2. Age range from 18 to 70 years old, regardless of gender; 3. The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2 points; 4. 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; 5. 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%; 6. Life expectancy greater than 8 weeks; 7. Voluntarily sign an informed consent form to understand and comply with the requirements of the study.
Exclusion criteria
1. Failure to achieve complete hematological remission, including residual extramedullary infiltration; 2. Previously received hematopoietic stem cell transplantation; 3. Received systemic chemotherapy within 2 weeks; 4. Previously received treatment with Blinatumomab; 5. Have a history of central nervous system leukemia or present with central nervous system leukemia; 6. Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc; 7. 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; 8. Chronic obstructive pulmonary disease with whole lung dysfunction; 9. Other serious diseases that may restrict patients from participating in this test (such as advanced infection, uncontrollable diabetes); 10. Concomitant arteriovenous thrombosis or hypercoagulable state; 11. 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; 12. Pregnant or lactating women; 13. Severe allergies to other monoclonal antibodies in the past; 14. Those who are unable to understand, comply with the research protocol or sign an informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progress-Free Survival | At Year 1 | Progression-free survival (PFS) is defined as the time from transplantation to disease progression or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of Relapse | At Year 1 | The time from the date of transplantation to disease recurrence: Disease recurrence, defined as one of the following: Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions. |
| Non-relapse Mortality | At Year 1 | NRM was defined as death after transplant that was not preceded by recurrent or progressive malignancy. |
| Overall Survival | At Year 1 | Overall survival (OS) is defined as the time from transplantation to death |
| acute graft versus host disease | At Day 100 | assessment of acute GVHD |
| chornic graft versus host disease | At Year 1 | assessment of chronic GVHD |
| Minimal Residual Disease | At Year 1 | Minimal residual disease is a small number of cancer cells left in the body after treatment. |
Countries
China
Contacts
Primary ContactJimin Shi
Outcome results
None listed