CCCG-ALL2025 LR-B-ALL計劃是基於CCCG-ALL2020計劃設計。這是一項臨床試驗,在所有新確診暫定低風險(LR)兒童急性淋巴細胞白血病(ALL)患者中,於誘導治療後使用14天 blinatumomab(Blina-14)作為早期強化治療,並於鞏固治療中使用第二次Blina-14,不論可測量殘留病灶(MRD)狀態如何。
適應症:Acute Lymphoblastic Leukemia ALL、Childhood Leukemia, Acute Lymphoblastic、B Cell Acute Lymphoblastic Leukemia (B-ALL)
收案條件
納入條件
- Must meet all items below:
- Age older than 1 year and younger than 18 years.
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
- Diagnosis of B-ALL by immunophenotyping.
- Low risk group
排除條件
- Should be excluded in the presence of any item below:
- T-ALL
- I/HR B-ALL group
- sIgM+
- Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
- Philadelphia chromosome positive ALL (Ph-ALL)
- ALL evolved from chronic myeloid leukemia (CML).
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction
- Secondary leukemia
- Known underlying congenital immunodeficiency or metabolic disease
- Congenital heart disease with cardiac insufficiency.
- Glucocorticoid treatment 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)
收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。