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Clinical Trial Summary

This study is open-label, multi-center, prospective study, which targets childhood patients with recurred acute lymphostatic leukemia including recurrence around marrow. This study is designed to administer Idarubicin for Reinduction stage. Patients with recurrence are sorted into groups with their potential risk, and depending on their recurrence point, time, reaction to treatment etc, they are sorted into low-risk group, high-risk group, and highest-risk group. Patients with high-risk group are going to be given blinatumomab at consolidation stage before hematopoietic stem cell transplantation. Patients with low-risk group who are not suitable for hematopoietic stem cell transplantation are going to be maintaining maintenance therapy for 2 years for chemotherapy.


Clinical Trial Description

1. Baseline demographics: Sex, Birth date, expire date (last follow-up date for the survivals) 2. Diagnosis of Acute lymphoblastic leukemia and treatment history: Diagnosed date, treatment history (Stem cell transplantation history, Administration of Blinatumomab history, recurrence date to check whether recurred within a month after received 4 therapies of induction) 3. Tests before actual administration: EKG and or Echo, Blood sample: Complete Blood Count/Diff/Platelets, Chemistry, Urinalysis, HIV, human chorionic gonadotrophin [female], Minimal Residual Disease[Next-generation sequencing, after induction / could be done after 1st, 2nd consolidation therapy] 4. Bone marrow aspiration ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05827549
Study type Interventional
Source Asan Medical Center
Contact Ho Joon Im, Professor
Phone +82-2-3010-3371
Email hojim@amc.seoul.kr
Status Not yet recruiting
Phase Phase 2
Start date April 1, 2024
Completion date December 31, 2032

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