OncoMatch/Clinical Trials/NCT05827549
Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Is NCT05827549 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for acute lymphoid leukemia.
Treatment: Reinduction(4weeks) · Cosolodation 1st(3weeks) · Consolidation 2nd(3weeks) · Blinatumomab 1st(High Risk Group)_4 Weeks · Blinatumomab 2nd (High Risk Group)_4 Weeks · Blinatumomab-Salvage 1st (Very High Risk Group)_4 Weeks · Blinatumomab-Salvage 2nd (Very High Risk Group)_4 Weeks · Intensification course · Maintenance(12 Weeks/Cycle) — This study is open-label, multi-center, prospective study, which targets childhood patients with relapsed acute lymphostatic leukemia including bone marrow recurrence. Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for relapsed acute lymphoblastic leukemia in children and adolescents.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Excluded: BCR Philadelphia chromosome positive
Patients with Philadelphia chromosome positive (Ph+) ALL
Excluded: CD19 non-expression
Patients with CD19-negative recurrent progenitor B-cell acute lymphoblastic leukemia (non-expression of CD19 in peripheral blood or bone marrow by flow cytometry) are not eligible for administration of Blinatumomab
Prior therapy
Must have received: — relapsed
1st recurred acute lymphoblastic leukemia patients
Cannot have received: allogeneic stem cell transplant
Patients who have never received allogeneic stem cell transplant
Cannot have received: (blinatumomab)
Patients who have never received blinatumomab before
Cannot have received:
In case of relapsed within 1 month after the end of induction with the same 4-drug therapy used in this study
Lab requirements
Kidney function
A serum creatinine based on age/gender as follows: 1 to < 2 years - Male (0.6) Female (0.6) 2 to < 6 years - Male (0.8) Female (0.8) 6 to < 10 years - Male (1) Female (1) 10 to < 13 years - Male (1.2) Female (1.2) 13 to < 16 years - Male (1.5) Female (1.4) ≥ 16 years - Male (1.7) Female (1.4)
Liver function
Adequate Liver Function defined as a direct bilirubin <3.0 mg/dL
Cardiac function
Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram
Adequate Renal Function -A serum creatinine based on age/gender as follows: ... * Adequate Liver Function defined as a direct bilirubin <3.0 mg/dL * Adequate Cardiac Function defined as: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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