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

NCT ID: NCT06125106

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2026-02-01

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.

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Blinatumomab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

HSCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

The President of The First Affiliated Hospital, College of Medicine, Zhejiang University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jimin Shi

Role: CONTACT

jiminshi@126.com

+8613657119907

Facility Contacts

He Huang, MD

Role: primary

hehuangyu@126.com

86-13605714822

Yongxian Hu, MD

Role: backup

huyongxian2000@aliyun.com

+8615957162012

Other Identifiers

IIT20230044C-R1

Identifier Type: -

Identifier Source: org_study_id