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Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

RecruitingPhase 2, Phase 3Ages 1 Month - 18 YearsAllInstitute of Hematology & Blood Diseases Hospital…
NCT06764238 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I/HR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I/HR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore: 1. The efficacy of two randomized Blinatumomab application scheme on I/HR-ALL as determined by MRD negatvitiy rate. 2. The efficacy of modified mini-hyperCVD + Venetoclax in I/HR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Blinatumomab (Group A)
  • Venetoclax (nonRand Group)
  • Blinatumomab (Group B)
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Where

27 sites
Anhui Medical University Second Affiliated Hospital
Hefei, China
Anhui Provincial Children's Hospital
Hefei, China
Fujian Medical University Union Hospital
Fuzhou, China
Guangzhou Women and Children's Medical Center
Guangzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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