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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-16
• Primary completion: 2025-01-01
• Completion: 2026-02-01
• First posted: 2023-11-09
• Last updated: 2023-11-09

Locations

1 site across 1 country: China