BridgeMD
Tests treatment safety and results for B-Cell Lymphoblastic Leukemia
Official title Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT06607419
What this study is testing
What is Blinatumomab?
Blinatumomab is an investigational medicine, being studied as a potential treatment for b-cell lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- 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 intermediate-risk: D19MRD ≥ 0.01%;
- people in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee
You likely can't join if
- sIgM+;
- ALL evolved from chronic myeloid leukemia (CML);
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
- Other secondary leukemias;
- CNS involvement;
- History of epilepsy; or convulsions within the last month;
See the full 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: A. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;
- people in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee
- sIgM+;
- ALL evolved from chronic myeloid leukemia (CML);
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
- Other secondary leukemias;
- CNS involvement;
- History of epilepsy; or convulsions within the last month;
- Known underlying congenital immunodeficiency or metabolic disease;
- Congenital heart disease with cardiac insufficiency;
- 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...
- Initial diagnosis of high risk;
- D46MRD ≥1%.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Fuzhou, Fujian, China
- Shanghai, Shanghai Municipality, China
- Ningbo, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Fuzhou, Fujian, China; Shanghai, Shanghai Municipality, China; Ningbo, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.