NCT06607419RecruitingPhase 2/3
Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 23 Sept 2024 · 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 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 4 Sept 2024
- Start date
- 21 May 2024
- Primary completion date
- 31 May 2025
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- NCT number
- NCT06607419
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 90
- From 21 May 2024 to the primary completion date, 31 May 2025
- 4 sites in 1 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.
Prior treatment
- Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression);
Other illness
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
- History of epilepsy; or convulsions within the last month;
- Known underlying congenital immunodeficiency or metabolic disease;
- Congenital heart disease with cardiac insufficiency;
Other
- sIgM+;
- ALL evolved from chronic myeloid leukemia (CML);
- Other secondary leukemias;
- CNS involvement;
- Initial diagnosis of high risk;
- D46MRD ≥1%.
Who the study is looking for
- 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:
- Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;
- Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee
Age in the registry: 1 month to 18 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Children's Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| Anhui Provincial Children's Hospital Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Ningbo Women and Children's Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Shanghai Children's Medical Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.