Clinical trial NCT06125106: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Acute Lymphoblastic Leukemia
Keywords: Minimal Residual Disease
Allogeneic hematopoietic stem cell transplantation
Blinatumomab
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progress-Free Survival
timeFrame: At Year 1
Secondary outcomes:
measure: Overall Survival
timeFrame: At Year 1
measure: Cumulative Incidence of Relapse
timeFrame: At Year 1
measure: Non-relapse Mortality
timeFrame: At Year 1
measure: Minimal Residual Disease
timeFrame: At Year 1
measure: acute graft versus host disease
timeFrame: At Day 100
measure: chornic graft versus host disease
timeFrame: At Year 1
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital of medical college of zhejiang university
state: Zhejiang
Study officials:
References: