Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Recruiting
Phase 2
Phase 3
Interventional Study
B-Cell Lymphoblastic Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Month – 18
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Shanghai Jiao Tong University School of Medicine · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion 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:
A. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermed…
Contacts