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Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol

RecruitingPhase 2, Phase 3Ages 1 Year - 18 YearsAllInstitute of Hematology & Blood Diseases Hospitalโ€ฆ
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In plain words

What the trial is, and whether it could suit you

CCCG-ALL2025 LR-B-ALL plan is designed based on the CCCG-ALL2020 plan. This is a clinical trial using 14 days of blinatumomab (Blina-14) as early intensification after induction therapy and 2nd Blina-14 in consolidation therapy in all newly diagnosed provisional low-risk (LR) pediatric acute lymphoblastic leukemia (ALL) patients, regardless of measurable residual diseases (MRD) status. We will compare the efficacy of chemotherapy combined with Blina-14, comparing to CAT+ intensification or historical regimens. Patients with early remission in depth will receive chemo-light late intensification and maintenance therapy afterwards. Early complete remission in depth and maintenance reduction will be determined by next-generation sequencing (Ig-NGS MRD).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Must meet all items below: 1. Age older than 1 year and younger than 18 years. 2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology. 3. Diagnosis of B-ALL by immunophenotyping. 4. Low risk group Exclusion Criteria: Should be excluded in the presence of any item below: 1. T-ALL 2. I/HR B-ALL group 3. sIgM+ 4. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria. 5. Philadelphia chromosome positive ALL (Ph-ALL) 6. ALL evolved from chronic myeloid leukemia (CML). 7. Down's syndrome, or major congenital or hereditary disease with organ dysfunction 8. Secondary leukemia 9. Known underlying congenital immunodeficiency or metabolic disease 10. Congenital heart disease with cardiac insufficiency. 11. Glucocorticoid treatment for โ‰ฅ14 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
  • Reinduction-2 omission
  • Chemo-light Maintenance 2
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Where

27 sites
Anhui Medical University Second Affiliated Hospital
Hefei, China
Anhui Provincial Children's Hospital
Hefei, China
Chongqing Medical University Affiliated Children's Hospital
Chongqing, 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

โ€ฆand 19 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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