New treatment options for children with high-risk B-cell 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 improve outcomes for children diagnosed with intermediate- and high-risk B-cell acute lymphoblastic leukemia (B-ALL) by evaluating the efficacy of two treatment approaches: a randomized controlled trial using Blinatumomab and a modified mini-hyperCVD regimen combined with Venetoclax for those who cannot afford Blinatumomab. The study will assess the rates of minimal residual disease (MRD) negativity as a primary endpoint, alongside overall survival and quality of life measures. Additionally, it will incorporate advanced evaluation techniques such as IgH rearrangement NGS MRD and pharmacotyping studies to enhance treatment personalization.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age older than 1 month to younger than 18 years.
2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
3. Diagnosis of B-ALL by immunophenotyping.

Exclusion Criteria:

1. Low-risk ALL
2. sIgM+
3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
4. ALL evolved from chronic myeloid leukemia (CML).
5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction
6. Secondary leukemia
7. Known underlying congenital immunodeficiency or metabolic disease
8. Congenital heart disease with cardiac insufficiency.
9. 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)

Where it's running

• Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
  Tianjin, Tianjin Municipality, China Recruiting
• Anhui Medical University Second Affiliated Hospital
  Hefei, Anhui, China Not yet recruiting
• Anhui Provincial Children's Hospital
  Hefei, Anhui, China Not yet recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Not yet recruiting
• Guangzhou Women and Children's Medical Center
  Guangzhou, Guangdong, China Not yet recruiting
• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Xiaofan Zhu, MD — Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
• Study coordinator: Jingliao Zhang, MD
• Email: zhangjingliao@ihcams.ac.cn
• Phone: +86 22 23909196

Similar studies

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

• Newly diagnosed low‑risk pediatric B‑cell ALL treatment with short blinatumomab courses

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• Plasma cell-free DNA in children with ALL to help monitor disease

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• Vaccine protection after blinatumomab in children with B-ALL

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• Laughter and fun yoga to ease chemotherapy pain in children

  This tests whether a home-based program of laughter and kid-friendly yoga can lower pain in children aged 2–10 who are receiving chemotherapy for acute lymphoblastic leukemia.

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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.