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

NCT06125106 | Unknown Phase 1

• 1 other identifier: IIT20230044C-R1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Lymphoblastic Leukemia

Keywords

Minimal Residual Disease; Allogeneic hematopoietic stem cell transplantation; Blinatumomab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall Survival

  At Year 1

• Cumulative Incidence of Relapse

  At Year 1

• Non-relapse Mortality

  At Year 1

• Minimal Residual Disease

  At Year 1

• acute graft versus host disease

  At Day 100

Study Arms (1)

Blinatumomab Group

EXPERIMENTAL

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.

Drug: Blinatumomab

Interventions

Blinatumomab 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.

Also known as: HSCT

Blinatumomab Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Age range from 18 to 70 years old, regardless of gender;
• The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2 points;
• 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;
• 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%;
• Life expectancy greater than 8 weeks;
• Voluntarily sign an informed consent form to understand and comply with the requirements of the study.

You may not qualify if:

• Failure to achieve complete hematological remission, including residual extramedullary infiltration;
• Previously received hematopoietic stem cell transplantation;
• Received systemic chemotherapy within 2 weeks;
• Previously received treatment with Blinatumomab;
• Have a history of central nervous system leukemia or present with central nervous system leukemia;
• Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc;
• 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;
• Chronic obstructive pulmonary disease with whole lung dysfunction;
• Other serious diseases that may restrict patients from participating in this test (such as advanced infection, uncontrollable diabetes);
• Concomitant arteriovenous thrombosis or hypercoagulable state;
• 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;
• Pregnant or lactating women;
• Severe allergies to other monoclonal antibodies in the past;
• Those who are unable to understand, comply with the research protocol or sign an informed consent form.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jimin Shi

CONTACT

+8613657119907; jiminshi@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The President of The First Affiliated Hospital, College of Medicine, Zhejiang University

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 9, 2023
• Study Start: November 16, 2023
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 9, 2023

Record last verified: 2023-10

Locations

CN (1)