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

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125106
• Other study ID #: IIT20230044C-R1
• Status: Recruiting
• Phase: Phase 1
• Start date: November 16, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: October 2023
• Source: Zhejiang University
• Contact: Jimin Shi
• Phone: +8613657119907
• Email: jiminshi[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: February 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Blinatumomab
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.

Locations

Country	Name	City	State
China	The first affiliated hospital of medical college of zhejiang university	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-Free Survival	Progression-free survival (PFS) is defined as the time from transplantation to disease progression or death from any cause.	At Year 1
Secondary	Overall Survival	Overall survival (OS) is defined as the time from transplantation to death	At Year 1
Secondary	Cumulative Incidence of Relapse	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.	At Year 1
Secondary	Non-relapse Mortality	NRM was defined as death after transplant that was not preceded by recurrent or progressive malignancy.	At Year 1
Secondary	Minimal Residual Disease	Minimal residual disease is a small number of cancer cells left in the body after treatment.	At Year 1
Secondary	acute graft versus host disease	assessment of acute GVHD	At Day 100
Secondary	chornic graft versus host disease	assessment of chronic GVHD	At Year 1