Blinatumomab
DrugRecruited patients will receive Blinatumomab since day 29 of induction for 14 days.
NCT Number: NCT06607419
The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is:
• If the flow cytometric MRD negative (<0.01%) rate and the NGS- MRD negative (<0.0001%) rate at the end of induction for patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol).
Participants will:
* Take 14 days full dose Blinatumomab; * With bone marrow evaluated before and after Blinatumomab treatment.
Interested in participating?
Request Info1 month–18 year
All sexes
Interventional
Phase 2 / Phase 3
Anhui Provincial Children's Hospital, Hefei, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;
Exclusion criteria
Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.
Time frame: From the date of Blinatumomab completion to one week after its treatment course
The flow cytometric MRD negative (<0.01%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)
Time frame: From the date of Blinatumomab completion to one week after its treatment course
The NGS- MRD negative (<0.0001%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)
Time frame: 5 years since the last recruited patient completed Blinatumomab.
The 5-year EFS of study group was significantly higher than that of the control group.
Time frame: From day 19 of induction therapy until the start of the second high-dose methotrexate regimen.
Comparison of adverse events in study and control groups
Time frame: Six-month since window phase
Comparison of healthcare costs in study and control groups
Time frame: From the day of or before Blinatumomab to 3-7 days after termination of Blinatumomab.
Immune cell subgroup, T-cell activation, depletion, and cytokine releasing will be studied before Blinatumomab and day 7 and day 14 during Blinatumomab, and 1 week after Blinatumomab discontinuation.
Contact information is provided by the study sponsor or research team.
Shuhong Shen, PhD/MD
CONTACT
Wenting Hu, MD
CONTACT
Shanghai Jiao Tong University School of Medicine
Other
Acronym: BBClean
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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