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

Phase 1

Recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Blinatumomab

• Registration Number: NCT06125106
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-05
• Last Update Submitted: 2023-11-05
• Study First Posted: 2023-11-09
• Last Update Posted: 2023-11-09
• Study Start: 2023-11-16
• Primary Completion: 2025-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blinatumomab Group	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
chornic graft versus host disease	At Year 1	assessment of chronic GVHD
Overall Survival	At Year 1	Overall survival (OS) is defined as the time from transplantation to death
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.
acute graft versus host disease	At Day 100	assessment of acute GVHD
Minimal Residual Disease	At Year 1	Minimal residual disease is a small number of cancer cells left in the body after treatment.
Non-relapse Mortality	At Year 1	NRM was defined as death after transplant that was not preceded by recurrent or progressive malignancy.

Trial Locations

Locations (1)

The first affiliated hospital of medical college of zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China