Recruiting
A Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
What is being tested
Blinatumomab
+ Conventional therapy
DrugOther
Who is being recruted
Burkitt Lymphoma+14
+ DNA Virus Infections
+ Hemic and Lymphatic Diseases
From 14 to 65 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: February 2022
Summary
Principal SponsorThe First Affiliated Hospital of Soochow University
Study ContactHuizhu Kang, MDMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2022
Actual date on which the first participant was enrolled.High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.
Official TitleA Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
Principal SponsorThe First Affiliated Hospital of Soochow University
Study ContactHuizhu Kang, MDMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 14 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Burkitt LymphomaDNA Virus InfectionsHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeTumor Virus InfectionsVirus DiseasesLymphoma, B-CellEpstein-Barr Virus Infections
Criteria
4 inclusion criteria required to participate
The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.
ECOG score is 0-2.
Expecting life span is more than 6 months.
Patients are free from severe organ dysfunction.
6 exclusion criteria prevent from participating
Patients are considered as tumer progression.
Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) <30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) >2.5mg/ dL or blood Creatinine clearance rate < 30ml/min.
Patients are combined with infection or other complications that can not tolerate chemotherapy.
Patients are suffering from central nervous system/solitary extramedullary leukemia.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalOn the 1st to 3rd day, Blinatumomab should be continuous intravenous use for 24 hours with 9ug/ day for those whose weight are equal to or greater than 45kg, and 5ug/ m2 / day for those whose weight are less than 45kg (maximum dosage is 9ug/ day) per 24 hours. On the 4th to 14th day, for the patients who are equal to or greater than 45kg, they will receive Blinatumomab at the dose of 28ug/ day with continuous intravenous administration, and those below 45kg are given a 24h continuous infusion of 15ug/ m2 / day (maximum dose is 28ug/ day). Bucy-based myeloablative conditioning regimen will be performed on the 15th day.
Group II
Bucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
The first affiliated hospital of Soochow University
Suzhou, ChinaOpen The first affiliated hospital of Soochow University in Google MapsRecruiting
One Study Center