Evaluating Blinatumomab for Pediatric B-Lymphoblastic Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy of Blinatumomab in children with newly diagnosed acute B-Lymphoblastic leukemia who have shown a poor response to initial chemotherapy. Participants will receive a 14-day treatment of Blinatumomab, with their bone marrow evaluated before and after the treatment to determine the rate of minimal residual disease (MRD) negativity. The study will compare the outcomes of these patients to historical controls to evaluate the effectiveness of the treatment.

Why it matters

Who can join: the full rules

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 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

Exclusion Criteria:

* 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 radiotherapy to relieve airway compression);
* Initial diagnosis of high risk;
* D46MRD ≥1%.

Where it's running

• Shanghai Children's Medical center
  Shanghai, Shanghai Municipality, China Recruiting
• Ningbo Women and Children's Hospital
  Ningbo, Zhejiang, China Recruiting
• Anhui Provincial Children's Hospital
  Hefei, Anhui, China Not yet recruiting
• Fujian Children's Hospital
  Fuzhou, Fujian, China Not yet recruiting

Study contacts

• Study coordinator: Shuhong Shen, PhD/MD
• Email: shenshuhong@scmc.com.cn
• Phone: 86-18930830638

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vaccine protection after blinatumomab in children with B-ALL

  This project will see if children and young adults (ages 1–21) with B-cell acute lymphoblastic leukemia who received blinatumomab keep protective immunity from routine childhood vaccines and whether revaccination restores immunity when levels are low.

  Recruiting at 2 sites Arkansas Children's Hospital Research Institute · Little Rock, Arkansas and 1 other locations · NCT07422337

• Blinatumomab plus low-dose donor cells after transplant for high-risk B-ALL

  This small, early-phase study tests whether giving blinatumomab with low-dose donor lymphocytes after allogeneic transplant is safe and helps long-term survival for people with high-risk B-ALL.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07677878

• LP-118 in combination with standard therapy for newly diagnosed Ph+ ALL

  This study tests whether adding LP-118 to the standard therapy for adults with Philadelphia chromosome–positive ALL is safe and useful.

  Recruiting at 2 sites Phase 1 Wake Forest University Health Sciences · Charlotte, North Carolina and 1 other locations · NCT07614022

• MK-1045 versus blinatumomab for relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia

  This trial will test whether MK-1045 helps people with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia more than the standard immunotherapy blinatumomab.

  Recruiting at 30 sites Phase 2/3 Merck Sharp & Dohme LLC · Toronto, Ontario and 29 other locations · NCT07570173

• Asciminib in children and young adults with relapsed or refractory Ph+ or ABL-class Ph-like ALL

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  Recruiting at 4 sites Phase 1/2 Novartis · Sydney, New South Wales and 3 other locations · NCT07387926

• Subcutaneous blinatumomab treatment for adults with CD19-positive mixed phenotype acute leukemia

  This trial tests whether giving blinatumomab under the skin can help adults with CD19-positive mixed phenotype acute leukemia, including older or unfit newly diagnosed patients, those with measurable residual disease after remission, and those with relapsed or refractory disease.

  Recruiting Phase 2 West Virginia University · Morgantown, West Virginia · NCT07222579

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.