Trials / Not Yet Recruiting
Not Yet RecruitingNCT06763302
NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,220 (estimated)
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine · Academic / Other
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to determine whether pediatric B-cell acute lymphoblastic leukemia (B-ALL) patients with negative deep minimal residue disease (MRD) can benefit from blinatumomab treatment. The main questions it aims to answer are: 1. Whether the application of blinatumomab can improve the long-term survival of next generation sequence (NGS) MRD-positive B-ALL children after consolidation therapy? 2. Whether the application of blinatumomab can benefit the NGS MRD-negative B-ALL children after consolidation therapy?
Conditions
- B Cell Precursor Acute Lymphoblastic Leukemia
- Pediatric
- Minimal Residual Disease
- Next Generation Sequencing (NGS)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Blinatumomab | The FDA has approved blinatumomab for post-consolidation treatment in all Ph-negative B-ALL cases, regardless of MRD status. Considering the high cost of blinatumomab and the financial burden on families, we aim to precisely identify the population who would benefit from blinatumomab and provide appropriate treatment. |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2027-12-31
- Completion
- 2030-12-31
- First posted
- 2025-01-08
- Last updated
- 2025-01-08
Source: ClinicalTrials.gov record NCT06763302. Inclusion in this directory is not an endorsement.