NCT06763302Not yet recruiting
NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL
Source: ClinicalTrials.gov · Last updated 8 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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?
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1220 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- NCT number
- NCT06763302
What you commit to
- Study type: Interventional
- Planned participants: 1220
- From 1 Jan 2025 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other tumors or immunodeficiency diseases present.
Age
- Age \<1 year or ≥18 years.
Other
- Immunophenotyping suggests mature B-cell leukemia, mixed-lineage leukemia, or T-cell acute lymphoblastic leukemia.
- Secondary leukemia or second tumor, CML blast phase ALL.
Who the study is looking for
- Clincial dianogsis of acute lymphoblastic leukemia (B-cell type) by morphology, immunology, cytogenetics, and molecular biology (MICM).
- Age ≥1 year and \<18 years.
- Informed consent signed, with the parents or guardians agreeing to a unified treatment protocol.
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.