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

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 marr

Trial Details

NCT ID
NCT06607419
Phase
PHASE2 / PHASE3
Sponsor
Shanghai Jiao Tong University School of Medicine
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • Blinatumomab
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Ningbo, Zhejiang, China|29.87819,121.54945

Key Eligibility Criteria

  • Age older than 1 month to younger than 18 years.
  • Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
  • Immunophenotyping: acute B-lymphoblastic leukemia;
  • Meet one of the following situations:

For full eligibility, visit ClinicalTrials.gov.

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