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RECRUITING
NCT06607419
PHASE2/PHASE3

Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

1 Month - 18 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-05-21

Completion Date

2030-05-31

Last Updated

2024-09-23

Healthy Volunteers

No

Interventions

DRUG

Blinatumomab

Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.

Locations (4)

Anhui Provincial Children's Hospital

Hefei, Anhui, China

Fujian Children's Hospital

Fuzhou, Fujian, China

Shanghai Children's Medical center

Shanghai, Shanghai Municipality, China

Ningbo Women and Children's Hospital

Ningbo, Zhejiang, China